project pre-feasibility report on proposed project...

M/S. UNIQUE C HEMICALS (A di v of J B CHEMIC ALS & PHARMACEUTICALS LTD) PANOLI

Page no. 1

PROJECT PRE-FEASIBILITY REPORT

ON

PROPOSED PROJECT

FOR

EXISTING & EXPANSION PROJECT

FOR BULK DRUGS & INTERMEDIATES MANUFACTURING FACILITY

OF

M/S. UNIQUE CHEMICALS (A Div of J B CHEMICALS & PHARMA LTD)

PLOT NO 5, PHASE-IV, GIDC, PANOLI -394116, DISTRICT – BHARUCH,

GUJARAT


Page no. 2

CONTENTS

Sr. No.

Particulars Page No.

1 SUMMARY 5 2 INTRODUC TIO N 5 2.1 The Project 9 2.2 Project Proponent 14 2.3 Nature of project 14 2.4 Market Feasibility 15 2.5 Demand Supp ly Gap 15 2.6 Employment Generation Due To The Project 15 3 PROJEC T DESCRIPTION 15 3.1 Type of Project 16 3.2 Project Location 16 3.3 Site selection 16 3.4 Size of project 17 3.5 Process Technology 17 3.6 Rawm aterial 17 3.7 Resource optimization/recycling reuse 17 3.7.1 Solvent recovery 18 3.8 Resource requirment 18 3.8.1 Land 18 3.8.2 Building 18 3.8.3 Power & Fuel 18 3.8.4 Water 19 3.8.5 Man power 19 3.9 Mitigation measures & EMP 19 3.9.1 Waste water Management 20 3.9.1.1 Wastewater Management 21 3.9.1.2 Wastewater Characteristics 24 3.9.1.3 Wastewater Treatment & Disposal 25 3.9.2 Gaseous emission & Control 29 3.9.2.1 Flue Gas Emissions 29 3.9.2.2 Process Emissions 30 3.9.3 Hazardous /non hazardous waste managment 30 3.9.4 Noise control& odour 32 3.9.5 Storage ,handling and transport of Hazardous

chemical 32

3.9.6 Health & Safety measures 33 3.10 Statutory permits 35 4 SITE ANALYSIS 35 4.1 Connectivity 35 4.2 Land use and land ownership 35 4.3 Topography 35 4.4 Existing landuse 36


Page no. 3

Sr. No.

Particulars Page No.

4.5 Existing infrastructure 36 4.6 Climate data 36 5 PLANNING BRIEF 38 5.1 Planning concept 38 5.2 Land use planning 38 5.3 Assessment of infrastructure Demand 39 5.4 Ammentities 39 6 PROPOSED INFRASTRUC TURE 39 6.1 Processing area 39 6.2 Non processing area 39 6.3 Green belt area 39 6.4 Social Infrastructure 39 6.5 Connectivity 40 6.6 Drinking water management 40 6.7 Sewerage system 40 6.8 Industrial waste management 40 6.9 Solid waste management 40 6.10 Power requirment & Supply 41 7 REHABILITATION & RESETTLEMENT (R &

R) PLAN 41

8 PROJEC T SCHEDULE & CO ST ES TIMATES 41 8.1 Project Implementation Schedule 41 8.2 Estimated project cost 42 9 ANALYSIS OF PROPOSAL 42

LIS T O F TAB LES

Table No.

Topic Page No.

1.1 List of probable Products ( Existing + proposed) 6 1.2 List of Hazardous Waste Generation & Disposal 8 2.1 List of Directors 12-13 2.2 Manpower Requirement 15 3.1 Salient Features of The Project Site 16 3.2 Water Requirement 19 3.3 Waste Water Generation 21 3.4 Waste Water Charctristics (Existing Scenario) 24 3.5 Waste Water Charctristics (Total Proposed

Scenario) 24

3.6 Name & Size of Each Unit of Effluent Treatment Plant

26

3.7 Details of Flue Gas Emissions 29 3.8 Details of Process Emissions 30 3.9 Detail of Hazardous Waste 31 3.10 Noise Level Measurment 32 3.11 Details of Storage of Hazardous Chemical 33 3.12 Details of area break up 38


Page no. 4

LIST OF APPENDIX

Appendix No.

Topic Page No.

I Brief manufacturing process & Material balance for the product

43-198

II Raw material consumption 199-209 III Safety health & environment policy 210 IV Consolidated Consent & Authorization & amendment 211-224 V C C A compliance report 225-228 VI Factory License & Factory layout 229-230

LIST OF FIGURES

Sr. No.

Description Page No.

1. Location Of Project Site 9

2. Satelite Lmaginary Of Location 10

3. Site Plant 11

4. Water Balance Diagram For Existing Scenario 22

5. Water Balance Diagram For Proposed Scenario 23 6. Flow Diagram Of Effluent Treatmentplant (Existing Scenario) 25

7. Flow Diagram Of Effluent Treatment Plant (Total Proposed Scenario)

26

8. Wind Rose Diagram 35 9. Enviromental Management Cell 222


Page no. 5

M/s. Unique Chemicals (A div of J B CHEMICALS & P HARM ACEUTICALS LTD.) at

plot no.5 phase - IV, GIDC, Panoli- 394116, District: Bharuch, State: Gujarat, existing

operating unit

It is proposed for Industrial project (Bulk drugs & Intermediates) for

v Existing project capacity -78.02 MT/month as well as

v Enhancement of existing product capacity & addition of new products.

Total capacity (Existing + proposed) -290 MT/Month.

v The unit is ZERO LIQUID DISCHARGE (ZLD) & will continue to reamian ZERO

LQUID DISCHARGE.

v Pollution load for Waste water is ZERO & continue to maintain Pollution load

ZERO.

v Unit has set up Reverse osmosis plant & evaporation system. Entire quantity of

waste water generated from ex isting pro ject & proposed enhancement treated in R-O

plant & reuse in Utility.

2.0 INTRODUC TIO N OF THE PROJEC T / BACKGROUND INFORMATION

BACKGROUND INFORMATION:

M/S. Unique Chemicals (A div of J B CHEMICALS & PHARMACEUTICALS LTD.) at

plot no.5, Phase IV, GIDC, Pano li-394116, District- Bharuch (Gujarat) India is engaged in

manufacturing of Bulk drugs and intermediates.

It is proposed for Industrial project (Bulk drugs & Intermediates) for




v The unit is ZERO LIQUID DISCHARGE (ZLD) & will continue to reamian ZERO

LQUID DISCHARGE. v Pollution load for Waste water discharge is ZERO & continue to maintain Pollution

load ZERO for Industrial waste water discharge.

v Unit has set up Reverse osmosis plant & evaporation system. Entire quantity of

waste water generated from ex isting pro ject & proposed enhancement treated in R-O

plant & reuse in Utility.

v The plot area of the unit is 64233 sq. meter.

1.0 EXEC UTIVE S UMMARY


Page no. 6

TABLE-1.1

LIS T O F PRO DUCT & CAPACITY

Capacity (MT/Month) Sr. No

Nam e of Products Existing Proposed

Total (Existing + Proposed

I Bulk drugs & Intermediates 1 Synthetic Active Pharmaceutical

Ingradients & Intermediates ( All sellable) 78.02 211.98 290

TO TAL O F PRO DUCT 78.02 211.98 290 II By Products 2 Methanol 120 301 421 3 IPA 10 20 30 4 Acetic acid 10 10 20 5 Dimethyl Formamide 0 7 7 6 Acetone 10 10 20 7 MIX PHENOL 10 20 30 8 Aluminum Chloride/ Aluminum hydroxide 140 380 520 9 Toluene 20 20 40

10 Sodium Chloride 15 40 55 11 Butanol 5 5 10 12 Hexane 10 15 25 13 Ethyl acetate 0 15 15 14 Dimethyl acetamide 0 10 10 15 Piperizine 0 15 15 16 Tetra Hydro Furan 0 5 5 17 Pyridine 0 10 10 18 Ethyl Cello-sol 0 30 30 19 Aceto nitrile 0 2 2 20 Ethylene dichloride/Methylene dichloride 0 2 2 21 Chloroform 0 5 5 22 Sodium Acetate 0 55 55 23 Dimethyl Sulphoxide 0 1 1 24 Methyl Iso butyl Ketone 0 2 2 25 Sodium Glyconate 0 15 15 26 *Other byproducts based on product

manufact ured -- -- Qty. depends on

products These are some of the by-product for the probable products as given in process descr iption. *This can change based on product manufact ured Investment:

v There is investment of Rs 45 Crore for the project.

Fuel: Unit uses natural gas as a fuel for bo iler & thermopac. Nat ural gas consumption will be 25000 SCM/Day. DG Sets are provided but stand by facility utilized in case of power failur Em ission:

v The stack emissions are from Boiler, Thermopac & DG Set.

v The process emissions are HCl gas generated from process reactors. HCL gas are carried

by HDPE p ipelines to alkali water double packed Tower, where HCl gas neutralize.


Page no. 7

Power:

v The present connected electrical load is 2500 KVA. This will be sufficient for capacity

Enhancement. However if require additional power available from DGVCL.

Water:

v The existing fresh water consumption is 200 KL/Day. It is proposed for additional

Fresh Water Consumption will be 325 KL/Day. Total fresh water consumption

will be- 525 KL/Day. For existing scenario Fresh water consumption for industrial

purpose- 145KL/Day , Domestic-35KL/Day & gardening- 20 KL/Day.

v For total proposed scenario fresh water consumption for Industrial purpose will be 437

KL/Day, Domestic purpose -50 KL/day & gardening- 38 KL/day.

Industrial waste water:

v In the existing practice, the Industrial waste water generated is 99KL/Day.

Waste water is treated in primary, secondary & tertiary treatment plant. The waste

Water is further treated in R-O plant. The permeate water from R-O plant used in

Utility. The R-O rejection evaporated in evaporation system. Salt generated from

Evaporation system is packed & sends to TSDF -site. The Unit is ZERO LIQUID

DISCHARGE for Industrial waste water.

v Under total proposed scenario (existing + expansion) the Industrial waste water

Generation for the unit will be 400 KL/Day. Under total proposed scenario the

Total industrial waste water will be treated in waste water treatment plant.

The waste water will be further treated in reverse osmosis plant, where waste water

recovery will be performed. The permeate water from R-O p lant will be used in utility &

R-O rejection will be send for evaporation & So lid waste collected will be send to TSDF

site. The unit will continue to maintain ZERO LIQUID DISCHARGE for Industrial

waste water.

Ø Thus there is no change in Pollution load for Industrial Waste water as there is no

discharge of waste water from the unit.

Domestic waste water:

v Under present scenar io Domestic waste water generated is collected & treated

Through Soak p it & Septic tank.

v Under total proposed scenario ( Existing + Proposed) Domestic waste water

Generated will be connected & treated through Septic tank & Soak p it. The

Overflow from the Soak pit will be collected & treated by Soil Bio Technology

Plant(SBT). SBT technology is patented environment friendly green technology.


Page no. 8

Hazardous waste: v Hazardous waste generation under existing & proposed scenario

TABLE-1.2

LIS T O F HAZARDO US WASTE GENERATION & DISPO SAL

S N

Type of Waste

Category of

Haz Waste

Existing Generation

Proposed Generation

Total Generation

Disposal

1. ETP sludge Category 34.3

120 MT/ Month

80 MT/ Month

200MT/ Month

Sent to common TSDF site BEIL Ankleshwar

A empty barrels & carboy

(R M)

Category 33.3

600 No/ Month

100No/ Month

700No/ Month

After decontamination Sell to Dealer hav ing PCB consent or send for refilling of same material

B Plastic liner

Category 33.3

1.8 MT/ Month

1.7 MT/ Month

3.5 MT/ Month

After decontamination Sell to Dealer hav ing PCB consent.

2.

C Glasswool, Thermocol

Category 33.3

25 kg/ Month

25 kg/ Month

50 kg/ Month

Sent to BEIL Ankleshwar

3. Used oil from DG set & compressor

Category 5.1

72 liter/ Month

28 liter/ Month

100 liter/ Month

Sold to authorize Recycler having PCB &

CPCB approval.

4. Distillation residue/ spent solvent

Category 25.2

5 MT/ Month

30 MT/ Month

35 MT/ Month

Incineration at common Incineration facility BEIL Or Co processing at Cement plant

5. Expired Drugs

Category 25.2

25 MT/ Month

10 MT/ Month

35 MT/ Month


6. Used Charcoal

Category 28.2

2.5 MT/ Month

12.5 MT/ Month

15 MT/ Month



Page no. 9

2.1. INTRODUC TION OF TH E PRO JEC T M/s. Unique Chemicals (A div of J B CHEMICALS & P HARM ACEUTICALS LTD.) at

plot no.5, Phase IV, GIDC, Pano li-394116, District- Bharuch (Gujarat) India is engaged in

manufacturing of Bulk drugs and intermediates. It is proposed for Industrial pro ject (Bulk

drugs & Intermediates) for


v Enhancement of existing product capacity & addition of new product s. Total

capacity (Existing + proposed) -290 MT/Month. v The unit is ZERO LIQUID DISCHARGE (ZLD) & will continue to reamian ZERO

LQUID DISCHARGE.

v Pollution load for Waste water discharge is ZERO & continue to maintain Pollution

load ZERO waste water discharge.

v The sole cr iteria of ZLD adopated by the Unit has been achieved by setting up

Reverse osmosis p lant & evaporation system.

v The plot area of the unit is 64233 sq. meter. Location map is attached as f igure 1 & 2.

FIGURE: 1

LOCATIO N OF PROJEC T SITE

Proje ct Site


Page no. 10

FIGURE: 2

SATELITE IMAGINARY O F LOCATIO N


Page no. 11

FIGURE: 3

SITE PLAN

UNIQUE C HEMICALS


Page no. 12

TABLE 2.1

LIS T O F DIREC TORS


Page no. 13


Page no. 14

2.2 INTRO DUCTION O F PRO JEC T PROPO NENT v Unique chemicals is a Bulk drugs & intermediate manufact uring div ision of

J. B.CHEMICALS & PHARMACEUTICALS LTD., located in t wo states Gujarat

& Maharashtra as well as Union tertiary Silvasa.

v Core business of the group company is manufacturing pharmaceutical formulation,

Bulk drugs & intermediates & marketing across the globe.

v Unique chemicals, is the flagsh ip company, for manufacturing of bulk drugs &

Intermediates. Operations of unit commenced in 1995 at Panoli.

v Unique chemical is having various certification & accreditations from USFDA &

EDQM Certificate of suitability as well as WHO GMP.

v The plants & system are built in accordance with Local & International regulatory

Compliance.

v The focus of the company is towards regulated markets like USA, EUROPE, and

JAP AN etc. 95% of the products manufactured is exported & balances 5% for

Captive consumption, thus earn export revenue.

v The company’s manufacturing un it in GIDC Panoli known to be quite attentive

towards their environmental and social obligation to the society. The unit is also

known for its excellent track record in environmental performance, safety & health.

UNIQUE QUALITY PO LIC Y Quality establishes the faith in the brands of the company therefore it cannot be

compromised at any cost. Quality is the prime focus, as we inculcate the spirit of quality in

every employee at all levels. Our quality standards meet all international norms, as they are

supported by well-written SOP s, which are continuously updated.

It is our commitment to design and manufacture products that respect the people and

environment.

2.3 NATURE OF PROJEC T

The proposed pro ject is for existing capacity as well as products & capacity enhancement

for existing Bulk drugs, intermediates & new products. The various categories of the drugs

like, anti inflammatory, anti hypertension, radio diagnostic, anti bacterial, antifungal, anti

histaminic, antidiabatic, sedative, anti parkinson, anti depressant, anesthetic etc. are

manufactured.


Page no. 15

2.4 NEED FO R THE PROJEC T The proposed expansion project is for ex isting anti inflammatory (NSID),radio diagnostic,

anti hypertension & cardiac, anti bacterial, antifungal, anti h istaminic, antidiabatic, sedative,

anti parkinson, anti depressant, anesthetic etc product requirement increases & introduction

of next generation new bulk drugs where efficacy is higher. Huge demand for generic drugs

from US & European market. During the year 2014, API industry growth is expected to

remain 21% & in terms of value to reach US $ 17 Billion. Average export of API remains

more than 50%.

2.5 DEMAND SUPPLY GAP Demand & supply gap is huge for the export market. Since existing products are generic in

nature. Inventors of generic products stop manufact uring & they prefer to import from

Indian market.

Demand for the anti inflammatory (NSID), radio diagnostic, anti hypertension & cardiac,

anti bacterial, antifungal & antidiabatic is increasing at the rate of almost 28-30 % during

last three years.

2.6 EMPLOYMENT G ENERATION DUE TO THE PROJEC T Due enhancement of existing product capacity & addition of new product, there will be increase in employment, for the technically qualified workforce.

Major employment force will be from in & around Local areas.

TABLE 2.2

MANPOW ER REQUIREMEN T

Sr. No.

Headings Existing work force

Proposed work force

Total after expansion

1 Technical Managerial level 4 4 8 2 Administrative Manager Level 6 1 7 3 Technical staff 30 5 35 4 Administrative staff 6 0 6 5 Technical skilled 34 9 43 6 Unskilled 120 10 130 7 Others – Secur ity etc 20 1 21 8 Total 220 30 250


Page no. 16

3.0 PROJEC T DESCRIPTION

Existing operating industrial project for Bulk drugs & intermediates, proposed for




The project falls under 5 (f) category of EIA notification 2006

3.2 PROJEC T LOC ATION The project is already located at block: p lot no 5, Phase-IV, Gujarat Industrial Development

Corporation, (GIDC) Panoli-394116, District –Bharuch, Gujarat. For proposed capacity

enhancement & addition of new product of the unit, no new land will be purchased. It will

be on Block: Plot no 5, Phase-IV, Gujarat Industrial Development Corporation, (GIDC)

Panoli-394116, District –Bharuch, Gujarat Notified Industrial area. Developed by Gujarat

Industrial Development Corporation.

The geograph ical positioning of the existing operational project site is at Latitude: 210 55’

North, Longitude: 730 00’ East.

TABLE: 3.1 SALIENT FEATURES OF THE PRO JEC T SITE Particulars Details Tehsil Panoli District Bharuch Approx. Geographical positioning

Latitude: 210 554446’ North Longitude: 730 000277’ East

Nearest city Panoli – 5.5 Km Nearest Highway National Highway No. -08 at a distance of 1 Km Nearest railway station Panoli at a distance 5 Km Nearest Air port Vadodara at a distance 75 Km Protected Areas/ Sanctuaries Nil within 25 Km radius The unit is in existance since year 1995-1996 3.3 CRITERIA FOR SITE SELEC TION

The proposed capacity enhancement & new product addition will be carried out in the

existing running site & plot only. Major infrastructure is already available on the site.

Located in a chemical industrial estate developed by GIDC and Government of Gujarat to

promote industrial activities in the region having all the necessary infrastructure facilities.

3.1 TYPE OF PROJECT


Page no. 17

For the project site was selected as major common facilities required for industrial activity

like, landfill T SDF site, incineration facility, CETP, treated eff luent conveyance pipe line to

deep sea etc. are already developed in the surrounding cluster. (Unit is Zero Liquid

Discharge , treated effluent conveyance to deep sea will not be utilized).

Notified Industrial area is developed by Gujarat Industrial Development Corporation.

3.4 SIZE & MAGNITUDE OF OPERATION Medium scale of industrial operation. The existing production capacity is 78.02 MT/Month,

after enhancement, total capacity (Existing + proposed) will be 290 MT/Month

3.5 PROC ESS TECHNOLOGY Process & technology for all bulk drugs & intermediate manufact uring has been developed

indigenously by companies R & D Centre. The material balance & chemical formulas for

the probable products are attached as Appendix- I.

3.6 RAW-MATERIALS Raw materials are available locally. The list of raw material for the probable product is as

per attached Appendix-II

3.7 RESO URC E OPTIMIZATION/REC YC LING AND REUS E The major resources required for the project is land, plant equipments, raw materials, power,

fuel, water etc.

As a part of resource optimization & recovery of products /byproducts it is proposed for

several byproducts. Some of the By-products are already recovered & so ld to GP CB

approved vendor.The Bye-products recovered will be either recycled or so ld to end users.

As a part of resource optimization it is proposed to carry out waste water treatment &

recovery of water. To reuse recovered water in utility with reverse osmosis plant. Thus

Project is “Zero Liquid discharge” for Industrial waste water & No pollution load for

Industrial waste water discharge.

New equipments will be purchase like for

Utility: Ch illing plant, Cooling tower, electrical PCC; Air compressor, DG Set, Bo iler &

Thermopac etc.

Process: Reactors (MS Glasslined,S S 316, M S Rubberlined),RCVD/VTD( SS 316 ,MS

Glasslined); Driers , filters, Centrifuges, ANFD , Storage tank (S S & HDPE) , heat

exchangers ( S S 316 , Graph ite), receivers ( S S316; MS lined) etc..

Environment protection: Scrubbers, MEE plant, Decanters, Filter press, Direct coal/baggase

fired hot gas spray drier, Aerators etc.

Laboratory: Lab. equipments like HPLC & GC etc.

& other equipment for material transfer, loading & unloading etc. as per needs.


Page no. 18

3.7.1 SOLVENT RECO VERY Recovery of so lvents is performed under closed system with maximum condensation &

traps, thus normal % recovery of the solvents ranges to more than 95%.

Some of the recovered solvents are reuse in the process for manufacturing at intermediates

stage. The so lvent recovered from finished product manu. are sold to end users. This is

because for the finished product impur ities levels are checked in PPB level & impurity

present in recovered solvents can affect the product quality.

3.8 RESO URC E REQUIREMENTS

The total water requirement for the existing and proposed scenar io will be met from local

authority GIDC notified area. The net fresh water requirement for total scanerio (ex isting +

proposed) after implementation of the proposal will be around 525 KL/Day, which is with

additional requirement of fresh 325 KL/Day. Power supply is from DGVCL. DGVCL is a corporation developed by government of

Gujarat for power supply & distribution management.

Being a developed area, facility like transport, road, rail & other infrastruct ure (hospital; fire

brigade etc) are easily available.

3.8.1 LAND The total plot area of the unit is 64233 sq. meter on which manufacturing activities is carried

out. The land is fairly plain terrain land and well-developed industrial estate. The proposed

project enhancement on same land. The altitude of area is about 19.2 meter above mean sea

level.

3.8.2 BUILDING New construction activities will be done for the proposed capacity enhancement & addition of new products. Construction activity will be done for the equipment for environment

protection measures.

3.8.3 POWER AND FUEL Power: Power supply is from DGVCL, developed by Government of Gujarat for power

supply & distribution management in the region. Electrical load is 2500 KVA, which will

take care of expansion of project. If require additional power will be available from

DGVCL. For emergency a standby power supply arrangement is provided through low noise

power generating sets.

Fuel: As a fuel environment friendly & clean fuel Natural Gas is used by unit. Nat ural gas is

supplied by Gujarat Gas Co. Ltd through network of pipeline & no storage is required to

keep at the unit. Natural gas consumption will be 25000 SCM/Day.


Page no. 19

3.8.4 WATER

The total water requirement for the existing and proposed capacity enhancement of the unit

is met from local authority GIDC notified area. The net fresh water requirement for total

scanerio (existing + proposed) after implementation of the proposal will be around 525

KL/Day, which is with additional requirement of fresh 325 KL/Day.

TABLE: 3.2 WATER REQ UIREMENT

Proposed Water

Consum ption

Total scenario (existing+

proposed)Water

C onsum ption

Water

consum ption (All quantity

in KL/Day)

Existing

Water

Consumption

Total Fresh Recovered Total Fresh Recovered

Process 84 298 298 0 382 382 0

Washing *11 19 0 19 30 0 30

Garden ing 20 18 18 0 38 38 0

Cooling

Tower

45 + (Rec. 80) 135 0 135 260 45 215

Boiler 5 20 5 15 25 10 15

Domestic 35 15 15 0 50 50 0

Total Water

consum ption

200 +

(Rec. 80)

505 336 164 785 525 260

*Under total scenario for washing on ly rec. water will be used.

3.8.5 MANPOW ER The total manpower requirement skilled & unskilled is fulfilled locally from the vicinity.

Bharuch being district centre & no. of technical & management institutions are established;

technically qualified manpower is easily available.

3.9 MITIGATIO N MEASURES & EMP As a part of environment management system EMP plans are defined & mitigation measures

are under taken with compliance of statutory provision. The detail of mitigating action &

EMP plan is as under for waste water, Air emission control & hazardous waste, noise

pollution. Environment management cell as per figure- 6


Page no. 20

3.9.1 WASTEW ATER MANAGEMENT Industrial waste water generated from manufact uring bulk drugs & intermediates is treated

in primary, secondary & tertiary treatment plant. Treated waste water further treated in R-O

Plant & evaporation system.

The existing scenario fresh water consumption is 200 KL/Day & Industrial waste water

generation is 99KL/Day. Domestic waste water will be -30 KL/day.

With total proposed scenario (Existing + proposed) the unit will be consuming additional

fresh water 325 KL/Day. The additional Industrial waste water generation will be 301

KL/Day. Domestic waste water generation will be – 35 KL/day. The break up of waste

water generation is given in Table 3.7. The water balance diagram for ex isting scenario is

given in Figure-4 & for total proposed scenario (Existing + proposed) is given in Figure-5.

In the existing scenar io, the Industrial waste water is treated in primary, secondary & tertiary

treatment plant. Treated effluent is than passed from Sand filter & Activated Carbon filter.

Company has set up R-O Plant for treatment of waste water with evaporation system.

The tertiary treated eff luent send to R-O Plant where waste water recovery is carried out.

The R-O Permeate is used back in the plant. The R-O rejection is evaporated in Evaporation

systems. The salt generated from the Evaporation system is send to TSDF site BEIL-

ANKLESHWAR. Thus unit is “ZERO LIQUID DISCHARGE” for Industrial waste water.

Domestic waste water is passed from Septic tank & Soak p it.

With total proposed scenario (Ex isting + proposed) unit will treat total Industrial waste

water 400 KL/Day in Waste water treatment plant, followed by treatment in R-O Plant.

Recovery of Waste water will be performed. Recovered water sends for use to Utility. R-O

Rejection will be evaporated in evaporation system. The salt generated from the evaporation

system will be packed & send to T SDF –site. Thus unit Pollution Load for waste water

discharge will be ZERO. Unit will continue to maintain “ZERO LIQUID DISCHARGE”

status for Industrial waste water. Pollution load for Industrial waste water discharge will be

continued to maintain ZERO.


Page no. 21

Domestic waste will be passed from Septic tank & Soak pit. The overflow from the Soak pit

will be send to Soil Bio Technology (SBT) technology. SBT technology is a patented

technology from IIT – Mumbai & Green techno logy.

3.9.1.1 WASTEW ATER G ENERATION

TABLE: 3.3

WASTE W ATER GENERATION

Waste Water

Generation

Existing Waste

Water Generation

Proposed W aste

Water Generation

Total

(Existing + Proposed)

Waste W ater Generation

Industrial waste water

Process 82.5 277.5 360

Washing 10.5 9.5 20

Cooling Tower 3 2 5

Boiler 3 12 15

Total Industrial

waste water

99 301 400

Dom estic waste water : Domestic 30 5 35

Total Dom estic

waste water

30 5 35

All quantities are in KL/Day


Page no. 22

FIGURE: 4 WATER BALANCE DIAGRAM FOR EXISTING SCENARIO

2, 00,000

5,000 45,000 35,000 20,000

PROCESS BOILER COOLING DOMESTIC AGRICULTURE

84,000

65,000

WASHING

ETP Plant

65,000 68,000

11,000

10,500 TO ETP 82,500

TO ETP 3,000

TO ETP 3,000

TO ETP 30,000

Loss 1500 Loss 2000 Loss 122000 Loss 5000

Loss 500

SOAK PIT & SEPTIC TANK Loss 6000

93,000

Reverse Osmosis Plant 33,000 R-O rejectio ns to Evaporation system R-O Permeate to utility

CON DEN ASTE

80,000

60000

20000

Solid was te (Salts) to TSDF site

Loss 6000

The I ndustria l waste wa ter trea te d in ETP pla nt. Treated waste wa ter is se nd to R-O Plant. R-O permeate water utilize in Utility. R-O Reje ction evaporate d in M EE syste m. Unit is ZERO LIQUID DISCHARGE for Industrial waste water. Domestic wa ste water is treated in Septic ta nk followed by Soa k pit. All quantity in Liters.

M/s. Unique C hemicals. (A Div. of J B CHEMICALS & PHARMACEUTICALS LTD.), PANO LI.

Page no 23

FIGURE: 5

WATER BALANCE D IAGRAM FOR TO TAL PRO POSED SCENARIO (EXISTING + PRO POSED)

All quantity is in Liters/Day

5, 25, 000

10,000 45000 50,000 38,000

PROCESS BOI LER COOLI NG

DOM ESTIC AGRI CULTURE

3, 82 ,000

WASHI NG

ETP

85,000

Loss 255000

20,000 TO ETP

3, 70 ,000 TO ETP

5,000 TO ETP

5,000 TO ETP

35000 To Sep tic tank, Soa k pit & than to SBT p lant

Loss 20,000 Loss

15000

Loss 10,000

Loss 5 ,000

90,000

Reverse Osmosis Pla nt TREATMENT

R O reject to Evap oration PLANT For Evaporation

R –O permea te f or re use

in Utility -260 KL

3, 95 ,000 TO RO PLANT

30,000

2 1 5 0 0 0

Solid wastes from MEE pla nt packe d & se nd to TSDF site BEI L -ANKLESHWAR

The I ndustria l waste wa ter treate d in ETP pla nt. Treated waste wa ter send to R-O Pla nt. R-O Per mea te wa ter send for utilization f or Utility. R-O Reje ction will be e vap orate d in Evaporation syste m. Unit will continue to maintain ZERO LIQUID DISCHARGE for Industrial waste water. Thus unit Wa ste water Loa d for disposal will be ZERO. Domestic wa ste water t reated in Septic tank & Soak pit, followed by SBT plant. Th e SBT treated water reused.

Loss 12,000

1 5 0 0 0

Loss 5 ,000


Page no 24

3.9.1.2 WASTEW ATER CHARAC TERIS TIC S

The characteristics of waste water before & after treatment is given in Table3.3

TAB LE: 3.4

WASTE WATER CHARCTRIS TIC S (EXISTING SCENARIO )

Sr. No.

Parameters Before Treatm ent

After Treatment

1 Ph 4- 6 6.8-7.5 2 Colour in Hazen 1000-1200 10-15 3 T.S.S in mg/L 1000- 1300 50-60 4 T.D.S. in mg/L 4000-6000 100- 150 5 B.O.D. in mg/L 2000- 3000 10-15 6 C.O.D. in mg/L 5000- 7000 30-50 7 Oil & Grease in mg/L 300-400 BDL 8 Phenolic Compound in mg/L 15-25 BDL 9 Ammonical Nitrogen in mg/L 5-10 Less than 1 10 Chlor ides in mg/L 3000-4500 30-40 11 Sulphate in mg/L 300-500 Absent 12 Sulphide in mg/L Absent Absent

TAB LE: 3.5

WASTE WATER CHARCTRISTICS (TOTAL EXISTING+ PROPOSED SCENARIO)

Sr. No.

Parameters Before Treatm ent

After Treatment

1 . p H 4- 6 6.8-7.5 2 Colour in Hazen 1000-1200 7-10 3 T.S.S in mg/L 1000- 1500 10-15 4 T.D.S. in mg/L 5000-8000 100- 150 5 B.O.D. in mg/L 2000- 3500 10-15 6 C.O.D. in mg/L 6000- 8000 30-50 7 Oil & Grease in mg/L 300-450 BDL 8 Phenolic Compound in mg/L 15-25 BDL 9 Ammonical Nitrogen in mg/L 10-15 Less than 1 10 Chlorides in mg/L 3000-5000 40-60 11 Sulphate in mg/L 300-500 10-15 12 Sulphide in mg/L Absent Absent

Unit is ZERO LIQUID DISCHARGE for Industrial waste water with R-O plant & Evaporation system. There is ZERO pollution load for waste water dischrge

Unit will continue to maintain ZERO LIQUID DISCHARGE for Industrial waste water with R-O plant & Evaporation system. There is ZERO Pollution load for the Industrial waste water discharge.


Page no 25

3.9.1.3 WASTEW ATER TREA TMEN T & DISPOSAL DETAILS OF EFFLU ENT TREATMENT PLANT The waste water generated from industrial activities is treated in an Effluent Treatment Plant Comprising of pr imary, secondary treatment & Tertiary treatment plant. The effluent generated from the plant is collected in a collection sump from where it is pumped to oil and grease trap to remove free oil from the raw effluent. After oil and grease removal the effluent goes to equalization cum Neutralization tank where Lime and Alum dosing is done. The effluent is pumped from equalization cum Neutralization tank & filtered through Filter press. The filtered clear effluent goes to Aeration tank for activated sludge biological treatment where non-settable suspended and colloidal organic matters are converted in settable biological mass which are settled in Clarifier. To maintain biomass concentration in Aeration tank active sludge from the Clarifier is partly recirculated in Aeration tank the over flow of the Clarifier. Treated eff luent is again passed from Sand filter & Activated Carbon filter. Company has set up R-O Plant for treatment of waste water with evaporation system. In R-O Plant waste water recovery is carried out. The R-O Permeate is used back in the p lant the R-O rejection is evaporated in Evaporation systems. The salt generated from the Evaporation system is send to TSDF site BEIL- ANKLESHWAR. In existing Scenario: Under present scenario Industrial waste water is treated in Waste water treatment plant followed by R-O plant. Recovered water is reused. Thus there is no discharge of the waste water from the unit. The R-O rejection is evaporated in evaporation system. The unit is “ZERO LIQUID DISCHARGE” for In dustrial waste water. Domestic waste water treated in Septic tank followed by Soak p it. Under total proposed scenario (Existing + proposed) Under total proposed scenario Industrial waste water generated will be continued to be treated in Waste water treatmnet plant followed by Reverse Osmosis Plant for Waste water recovery. R-O permeate water is collected & send to the Utility for reuse. R-O Rejection water to Evaporation plant, concentrated dried & salt collected are packed in bags & send to TSDF site BEIL – ANKLESHWAR. The unit is “ZERO LIQUID DISCHARGE” for In dustrial waste water. The Pollution load for Industrial waste water discharge will be ZERO. Pollution load for Industrial waste water discharge with total proposed scenario(Ex isting + proposed) will remain ZERO. Domestic waste water treated in Septic tank, Soak p it. The overflow from Soak pit will be treated in SBT (Soil Bio Technology) plant. SBT is pateneted green technology. v The solid waste generated from the effluent treatment facility, from the Filter

press.The solid sludge is transferred to the sludge collection & drying bed. The sludge collection/drying bed are two nos. The sludge a collection cum drying bed is provided with HDPE liner & from the bottom are connected to the Leatchet collection sump from leatchet collection sump what ever liquid eff luent collected are transferred to Collection tank for treatment.

v The sludge after drying collected in to the HDPE bags & send to the common secured land fill facility at Ankleshwar Bharuch Enviro Infrastructure Ltd


Page no 26

TAB LE: 3.6

NAME & SIZE O F EAC H UNIT O F EFFLUENT TR EATM ENT PLANT

CAPACITY SN NAME O F UNIT

EXIS TING PRO PO SED TO TAL (Existing + Proposed)

1 Oil & Grease Trap 7KL 13KL 20KL - 1no.

2 Equalization/ Neutralization Tank

400KL 400KL 800 KL

3 Filter press 1 2 3 no. 4 Collection sump 20KL 40KL 60 KL 5 Primary Aeration tank 600KL 600KL 1200 KL - 2 no. 6 Primary Clar ifier 30KL 40KL 2 nos.

7 Secondary Aeration tank 310KL X 2no.

310KL X 1 no.

960 KL- 3no.

8 Secondary Clarifier 40 KL 40 KL 80 KL – 2 no. 9 Final Clar ifier 40KL 40KL 80 KL – 2 no.

10 Chemical Solution Tank 5KL X 2no.

5KL X 1 no.

3 no.

11 Chemical solution house 18 m3 space --

12 Sludge dry ing bed 200KL 300KL 500 KL

13 Sand filter 1 1 2 14 Carbon filter 1 1 2 15 Treated water tank 3 1 4

16 ONLINE CAMERA SYST EM 1no. 1 no.

17 Reverse Osmosis Plant 210M3/day ( 160+50)

200M3/day 3 no.

18 MEE system 75M3/day (50+25) - 2 no.

19 Direct Baggase/Coal fired hot gas Spray dr ier /MEE

-- 150 M3/day 1 no.


Page no 27

FIGURE: 6

FLO W DIAGRAM O F EFFLUENT TR EA TMEN TPLANT

(EXISTING SC ENARIO)


Page no 28

FIGURE: 7

FLO W DIAGRAM O F EFFLUENT TR EA TMEN T PLANT (TOTAL PROPO SED SC ENARIO )


Page no 29

3.9.2 GAS EOUS EMISSIONS & CONTROL The unit is generating

v Flue gas emission from bo iler , thermopac, Direct fired Baggase/ Coal f ired hot

Gas spray drier, & D G set (stand by facility)

v Process emissions are HCl gas generated from reaction.

3.9.2.1 FLUE GAS EMISSIONS

TAB LE 3.7

DETAILS OF FLUE GAS EMISSIONS

STACK EMISSION S N

Stack/ Vent attached to

Heig ht of stack

Dia of

Stack

Type of Fuel

Fuel Consumptio n Pa rameter Permissible

limit

1.

Boiler -6 MT/Hr

(Existing)

30 meter 60 cm Natural

Gas 12000

SM3/Day

SPM SO2 NOX

150 mg/Nm3

100 pp m 50 pp m

2.

Boiler -8 MT/Hr

(Proposed)


Gas 15000

SM3/Day

SPM SO2 NOX

150 mg/Nm3

100 pp m 50 pp m

3.

Boiler -3 MT/Hr (Existing)


Gas 3600 SM3/Day SPM SO2 NOX

150 mg/Nm3

100 pp m 50 pp m

4.

Direct hot gas Bagg ase/co al

fired sp ray drier ( Proposed) 6.5 m3/hrs

30 meter 60cm Natural

gas/ Co al 9600/12000 SPM SO2 NOX

150 mg/Nm3

100 pp m 50 pp m

5.

Th ermo Pac TP-04

(Existing-1 No &

Proposed -2 No )


Gas 2400 SM3/Day SPM SO2 NOX

150 mg/Nm3

100 pp m 50 pp m

6.

D.G Set as stand by(Existing – 400 KVA -2no & 250

KVA -1No 1010 K VA – 1 no) Proposed

2000 K VA-1 no.

07 meter above

building height

15 cm HSD

70 Lit/ hrs/ 1010KVA & 45 Lit /hrs 400 KVA 90 liter /hr -1010 KVA . 170 liter/hrs.- 2000KVA

SPM SO2 NOX

150 mg/Nm3

100 pp m 50 pp m


Page no 30

3.9.2.2 PROC ESS EMISSIO NS TAB LE 3.8

DETAILS OF PROC ESS EMISSIO NS

Process emissions

S N

Stack/Vent attached to

Height of stack

Dia of Stack

Pollution Control

equipment Pa rameter Permissible

limit

1.

Indolinone Reactor & quench er – 8 Vent 3 -

Existing & 5-Proposed

17 meter 30 cm Double packed Alkali Scrubber HCl 20 mg/N m3

2

CPDCA Reactor- 4 Vent

2- E xisting & 2 – propos ed

17 meter 30 cm Double packed Alkali Scrubber HCl 20 mg/N m3

3.9.3 HAZARDO US WASTE MANAG EMEN T

Unit generates hazardous waste from effluent treatment & process. The hazardous

generated is collected, packed & stored in a place as per category of waste. The

hazardous waste like drums, a liner etc. are decontaminated & than disposal is carried

as per P CB permission. The hazardous waste is generated from effluent treatment &

process is as under. The Hazardous waste treatment & disposal is carried out as per

PCB permission.

ETP Sludge: At effluent treatment plant during treatment ETP sludge is generated,

which are filtered through filter press. Collected in sludge bed, packed in bags & send

to TSDF site BEIL- ANKLESHWAR

Used drum s & Plastic liners: The drums & carboys which after use, ret urned to the

party refilling of the same raw material. The drums which not returned to party for

refilling are decontaminated & then sold to PCB approved dealer

Used C arbon: The spent carbon after used in the final crystallization separated &

collected into LDPE liner bags & packed in to spent carbon collection area spent

carbon is being sent to Ankleshwar at BEIL Ankleshwar OR for coprcessing at

cement industry.


Page no 31

Expired drugs & Medicine/ off specification m aterial: expired drugs & medicine /

off specification material is sending for incineration at common facility BEIL

Ankleshwar OR for coprocessing at cement industries.

Distillation residue: Distillation residue material is sending for incineration at

common facility BEIL Ankleshwar OR for coprocessing at cement industries.

Used Oil: Used oil is send to CPCB approved oil recycler OR is send for

coprocessing at cement industries.

The details of hazardous waste is as per table no 3.9

TAB LE: 3.9

DETAIL O F HAZARDO US WASTE

Sr. No.

Type of Waste

Category Existing Generation

Proposed Generation

Total (Existing + proposed) Generation

Disposal

1. ETP sludge 34.3 120.0 MT/Month

80.0 MT/Month

200.0 MT/Month

Sent to common TSDF site BEIL Ankleshwar

A Empty barrels & carboy from R .M

33.3 600. No/ Month

100.0 No/ Month

700.0 No/ Month

After decontamination Sell to Dealer hav ing PCB consent or send for refilling of same material

B Plastic liner

33.3 1.8 MT/Month

1.7 MT/Month

3.5 MT/Month

After decontamination Sell to Dealer hav ing PCB consent.

2.

C Glass wool, thermocol

33.3 25 kg/ Month

25 kg/ Month

50 kg/ Month

Sent to BEIL Ankleshwar

3. Used oil from DG set & compressor

5.1 72 liter/ Month

28 liter/ Month

100 liter/ Month

Sold to authorize Recycler having PCB & CPCB approval.

4. Distillation residue/spent solvent

25.2 5 MT/ Month

30 MT/ Month

35 MT/ Month


5. Expired Drugs

25.2 25 MT/ Month

10 MT/ Month

35 MT/ Month


6. Used Charcoal

28.2 2.5 MT/ Month

12.5 MT/ Month

15 MT/ Month



Page no 32

3.9.4 NOISE CONTROL & ODOUR

NOISE: There will be no major activities due to which noise would be generated, other than

compressor & D G Set. For control of noise pollution D G Set are prov ided with

CANOPY. The control measures taken for noise level reduction are

v Proposed DG Set & compressor will be with CANOP Y.

v Ear plug & muffs provided to the employee work ing in utility area.

The details of Noise level measurement are as per table no. 3.10

TAB LE: 3.10

NOISE LEVEL MEASURMEN T

Sr. No.

Location Noise Level Measured(d B(A))

1 Near Main Gate 61-63 2. Plant Area 71-73 3. Near Boiler House 79-80 4. ETP Area 64-66 5. Nr D G Set 72-75

ODOUR: For odour control the operations are carr ied out in close system. Charging of liquid

raw materials is done through fix pipeline either by pump having mechanical seal or

vacuum transfer. So lid transfer done by vacuum or under negative pressure.

3.9.5 STORAG E, HANDLING AND TRANSPORT O F HAZARDO US CHEMICALS Storage, handling & transport of hazardous chemicals are done through dedicated

storage tanks, fix piping, pumps having mechanical seal. For each liquid chemical

handling a measur ing receiver is provided, through which required quantity is

transferred & used for the reaction. Overflow of the measur ing receiver is connected

back to the tank. All the tanks & measuring receivers are provided with close type

calibrated level indicator. The tanks & receivers are examined & tested by third party

regularly. The liquid raw material is received through road tankers from

manufact urer. Unloading of the road tanker is done with tanker unloading permit. It is

ensured that there is no leakage spillage or exposure of chemicals.


Page no 33

TAB LE: 3.11

DETAILS OF STORAGE O F HAZARDO US CHEMICAL

Sr. No.

Name of Chemical Material of C onstruction

Storage C apacity ( KL)

1 Sodium Methoxide solution

Mild steel 20+20 +10= 50

2 Methanol Mild steel 20+10 +5 =35 3 Toluene Mild steel 10 4 Ethyl Cello sol SS/M S 15 +15 =30 5 Caustic lye Mild steel 10/10 6 Aniline Mild steel 20/20 7 HCl HDPE 20/10 8 High speed Diesel Mild steel 10 9 Acetone Mild steel/ SS 10/5 10 Isopropyl Alcoho l Mild steel/ SS 10/5 3.9.6 HEALTH AND SAFETY MEAS URES

The unit is having well defined safety, health & environment policy. EHS policy is

attached as per Appendix-III.

The unit is having on site & off site emergency plan. The rehearsal of onsite

emergency plan is performed at regular interval. Safety manual is in place. Safety

booklet in local language is given to each employee.

The brief description of safety measures implemented is as under.

1) At the storage tank of the acid & alkali provided with label capacity. Proper

material of construction, Level indicator, Dyke wall with acid proof brick lining for

Acid st. tank. All tanks are prov ided with pumps & transfer pumps with mechanical

seal.

2) The statutory notice for acid & alkali danger is published in storage area.

3) Safety shower eye washers are prov ided in plant

4) Transfer of corrosive & toxic chemicals by close circuit only by pump & wearing

necessary personal protective equipments

5) At the hazardous chemicals marked with separate colour code

6) At the revolving & moving parts of the machiner ies are properly guarded.

7) Electrical cables, Earthing, Earth leakage circuit breakers lighting arrestor shock

proof safety equipment are provided to avoid electric shock


Page no 34

8) The vessels, Pipelines etc are properly earthed & the test of earthing continuity is

done regular ly.

9) The adequate quantity of Foam DCP, CO2 type fire f ighting equipment is

available

10) We have got both overhead & underground water tank for emergency. Total water

storage is 9,50,000 liters available at site.

11) Emergency light, Siren, veh icles, f irst aid center etc are prov ided & lighting

arrestor is provided at the top of the factory

12) The complete plant is having total flame proof electrical installation

13) Proper care for lighting & ventilation is taken at design level

14) Necessary antidotes. Medicines are provided in our OHC room.

15) All buildings plan & installation are as per relevant acts & duly approved by

competent Government Authorities

16) Process & equipment are designed by qualified & experienced professionals &

fabr icated to applicable national international codes with stage wise inspection.

17) Pressure relief valves installed on the reactor & jackets where ever required.

18) Hazardous process are controlled by trained workers & qualified & experienced

supervisor

19) Safety feat ure such as fire extinguishers. Fire hydrant system & suitable personal

protective equipment (PPE) provided. Regular operation & testing of fire

extinguishers

20) Safety tank provided to collect contaminated fire-water, in case of f ire emergency.

21) Use of flame proof electrical equipment flame arresters & breather valves

22) Provision of earthing & lighting arrester to prevent electrical fires & explosion

inflammable explosive chemicals storage processing areas

23) Periodic inspection & testing of pressure vessels, equipment, machineries &

equipment handling hazardous substance

24) Training of workers & staff for the fire fighting work permit system, first aid, and

safe handling of hazardous chemicals & integrating safety, in all activities.

25) Adequate scrubber system provided to control air po llution

26) Safety work permit system for all work to perform including vessel entry, hot

work, work ing at height etc.

27) Accident incident reporting system & information to employer

28) Mutual aid arrangement with neighbor ing unite & Disaster Preventation


Page no 35

Management Center (DPM C) for quick assistance for any emergency

29) Occupational Health Center is available in the campus. Qualified Doctors is

visiting the site, routine & annual medical check-up for the employees being

carried out

30) Total 3-seat of SBA available & adequate training given to the worker.

31) MSDS available for all chemicals handled.

32) Emergency telephone no are displayed at strategic locations.

33) Periodical medical check up all employees

3.10 STATUTO RY PERMITS Unit is having valid consolidated consent & authorization from Gujarat Pollution

Control Board. Attached as Appendix-IV. CC & A compliance report is attached

Unit is having valid factory license from department of industrial health & safety.

Attached as per Appendix-V.

4.0 SITE ANALYSIS

4.1 CO NNEC TIVITY The GIDC Panoli is connected by road & rail to major cities like Bharuch-30 Km,

Vadodara-75 Km, Ahmedabad-200 Km, Surat- 60 Km & Mumbai- 380 Km. National

high way no. 8 is 1 Km from the unit. Nearest railway station Panoli is at 5 Km

distance. The nearest air port Vadodara is at approx 75 Km distance from un it.

4.2 LAND US E AND LAND OWNERSHIP

GIDC has allotted a plot to M/s. Unique Chemicals (A div of J B CHEMICALS &

PHARMACEUTICALS LTD.) for establishing bulk drugs & intermediate

manufact uring unit. The plot is fully owned by M/s. Unique Chemicals (A div of J B

CHEMICALS & PHARMACEUTICALS LTD.). The plot is utilized exclusively for

manufact uring of bulk drugs & intermediates only. There is no residential facility.

There are well design roads, with tree plantation on the road side & periphery of

compound wall. The boards are displayed for direction, safety & buildings. A proper

compound wall with gate including emergency gate is provided.

4.3 TO POGRAPHY Total plot area is plain terrain land, when allotted. Surrounding area is also fairly p lain

& flat.


Page no 36

4.4 EXIS TING LAND US E, FORES T, WATER BO DIES, NATIO NAL PARK ETC…

There are no forest area, no water bodies, no national park, no wild life Sanctuary &

no monuments of historical importance located within 20 Km area of ex isting plot.

4.5 EXISTING INFRAS TRUC TURE The project is located in a well developed & established industrial zone. The essential

facility like internal roads, storm water drains, water supply, and power supply to

industries, transport vehicles etc. are already available.

4.6 CLIMATE DATA

For Baseline St udy, site specific meteorological data for st udy period from October

2012 to December 2012 is shown at below Table. As per gathered meteorological

data, the maximum temperature is 33.8o C; whereas the minimum temperature is

13.2o C. The relative humidity levels varied from 32 to 71. The maximum and

minimum as well as relative humidity for a period of October 2012 to Decem ber

2012 are presented in below Table

MIC RO METRO LOGIC AL DATA

Based on the site specific metrological data, wind rose has been prepared for the

post monsoon season period bet ween the October 2012 to Decem ber 2012. As per

the metrological data, it shows that the average wind speed in October, November,

and December 2012 is 1.33 m/s with wind direction blowing to SW. The wind rose

prepared from same data is shown at Figure No. 8.

Temperature(oC ) Humidity (%) Rain fall (mm) Month (2012) Maximum Minimum Maximum Minimum Maximum Minimum October 37.4 19.4 071 042 00 00 November 36.4 14.4 063 032 00 00 December 33.8 13.2 068 036 00 00


Page no 37

FIGURE: 8

WIND ROSE DIAGRAM


Page no 38

5.0 PLANNING BRIEF

5.1 PLANNING CONCEPT The total proposed project (Existing + proposed) is on existing plot. The demand for

the gener ic drugs for the export market have rise tremendously for the quality product.

Our company’s existing products are registered through regulatory process with many

countries & MNC company. Products are registered with DMF no, hence huge

international market is open to products manufact ured by company.

5.2 LAND US E PLANNING There will be no change in GIDC land use pattern. total proposed project (Existing +

proposed) will be carr ied out in existing company plot only. There will be no change

in plan layout in existing premises. The breakup of area is as per Table 5.1.

TAB LE 3.12

DETAILS OF AREA BREAKUP

Sr.

No.

Particulars Area in Sq. Meter % Total Area

1 Production area ( GF) 7100 11

2 Raw material storage area 1058. 1.6

3 Hazardous Chemicals storage area 855.84 1.3

4 Finished product storage area 300.0 0.5

5 Solvent storage area 2604 4

6 Efflu. treatment & Haz waste

storage

2026.68 3.15

7 Utility area 1570 2.4

8 Office building & Q C Lab (GF) 1736.4 2.7

9 Green belt area 13500 21

10 Road & open space 33359 51.9

11 Transformer yard 125 0.2

Total 64233 100

The detailed plan layout is attached as APPENDIX-VI


Page no 39

5.3 ASS ESSMENT O F INFRAS TRUC TURE DEMAND

Since the project enhancement is proposed on the existing plot only, no additional

infrastructure will be required to develop. The ex isting effluent generated &

additional effluent generated will be treated in ETP plant followed by R-O plant. The

waste water recovery will be done & unit’s Load for Industrial waste water Discharge

will remains ZERO same as present. The Industrial waste water generated after

proposed enhancement of existing product & new products will be recovered through

R-O plant & recovered water will be utilized for utility.

Additional haz waste generated due to enhancement will be send to BEIL –

Ankleshwar & haz waste with calorific value will be send to cement industry for co

processing.

5.4 AMENITI ES/FACILITI ES The area around GIDC, panoli is very well developed. Villages are having drinking

water supply facility. A hospital, primary health centre & other well equipped medical

facility is accessible to all population.

Educational facility is also available for technical, non technical & management

education around GIDC. Good tar & rcc road, with transportation facility is available.

The villages have connectivity through telephone lines & mobiles. Other facility like

bank, f ire brigade, police station, Aaganwadi etc are available in vicinity.

6.0 PROPOSED INFRAS TRUC TURE

6.1 PROC ESSING AREA Existing plot area will be utilized for proposed expansion activity with development

of process, Utility & waste water treatment area.

6.2 NO N PROCESSING AREA The non processing area comprising of ETP plant & haz waste storage area is 2026.68

sq. meter

6.3 GREEN B EL T AREA The 21 % of total area is used for green belt.

6.4 SOCIAL INFRAS TRUC TURE The existing facility will be adequate to take care of social Infrastructure.


Page no 40

6.5 CO NNEC TIVITY

The GIDC Panoli is connected by road & rail to major cities like Bharuch-30 Km,

Vadodara-75 Km, Ahmedabad-200 Km, Surat- 60 Km & Mumbai- 380 Km. National

high way no 8 is 1 Km from the unit. Nearest railway station Panoli is at 5 Km

distance. The nearest air port vadodara is at approx 75 Km distance from unit.

6.6 DRINKING WATER MANAG EMEN T The unit has already made provision for dr inking water at various locations within the

industry.

6.7 SEWAGE SYSTEM

The sewage is collected through a chamber & transferred through underground

pipeline to Septic tank. From Septic tank sewage water is transferred to soak pit.

Under total proposed scenario the sewage water after treatment in Septic tank & Soak

pit will be treated in SBT technology plant & than used.

6.8 INDUS TRIAL WAS TE MANAGEMENT

DETAILS OF EFFLU ENT TREATMENT & PLANT The waste water generated from industrial activities is treated in an effluent treatment

plant comprising of primary, secondary treatment & tertiary treatment plant. The

treated effluent from ETP plant further treated Reverse osmosis plant for waste water

recovery. From R-O plant, R-O permeate water is co llected & send to the utility for

reuse. R-O rejection water is send to evaporation plant, concentrated dried & solid

waste collected are packed in bags & will be send to TSDF site BEIL – Ankleshwar.

Unit Load for the Industrial Waste water DISCHARGE is ZERO. Unit is ZERO

LIQUID DISCHARGE.

Under Total proposed scenario Industrial waste water generated from the (Existing +

proposed activity) will be treated in Waste water treatment plant followed by R-O

plant. R-O permeate recovered will be utilized in utlity after & R-O rejection

evaporated in Evaporation system. Thus Pollution load for waste water discharge will

remain ZERO. Unit is ZERO LIQUID DISCHARGE.

6.9 SO LID WAS TE MANAGEMENT

Unit generates hazardous waste from effluent treatment & process. The hazardous

waste generated is collected, packed & stored in a place as per category of waste. The

hazardous like drums, a liner etc. are decontaminated & than disposal is carried as per


Page no 41

PCB permission.The hazardous waste is generated from effluent treatment & process

is as under.

Each hazardous waste is treated & disposal is carried out as per GPCB.

ETP Sludge: At effluent treatment plant during treatment ETP sludge is generated,

which are filtered through filter press. Collected, packed in bags & send to TSDF site

BEIL- Ank leshwar.

Used drum s & Plastic liners: The drums & carboys which after use, ret urned to the

party refilling of the same raw material. The drums which not returned to party for

refilling are decontaminated & then sold to GP CB approved drum dealer

Used C arbon: The spent carbon after used in the final crystallization separated &

collected into LDPE liner bags & packed in to spent carbon collection area spent

carbon is being sent to Ankleshwar at BEIL Ankleshwar for incineration OR for

coprcessing at cement industry.

Expired drugs & medicine/ off specification m aterial: Expired drugs & medicine /

off specification material is sending for incineration at common facility BEIL

Ankleshwar OR for coprocessing at cement industries.

Distillation residue: Distillation residue material is sending for incineration at

common facility BEIL Ankleshwar OR for coprocessing at cement industries.

Used Oil: Used oil is send to CPCB approved oil recycler OR is send for

coprocessing at cement industries.

6.10 POW ER REQUIREMENT & SUPPLY

The unit is hav ing electrical load is 2500 KVA, which will take care of total proposed

scenario. For emergency a standby power supp ly arrangement through low noise

Power generating sets.

7.0 REHABILITA TION AND RES ETTL EMENT(R & R) PLAN Since enhancement project is located in existing plot allotted by GIDC, in Notified

area, no R & R p lan is required.

8.0 PROJEC T SC HEDULE & COST ESTIMATES

8.1 PROJEC T IMPLEM ENTA TIO N SCHEDULE

The enhancement project will be implemented on ly after obtaining Environment

Clearance from Ministry of Environment & Forest & immediately after getting EC,


Page no 42

the project proponent will app ly for Consent to Establish to Gujarat Pollution Control

Board. It is expected that this process will be completed by January-2018.

8.2 ES TIMATED PROJEC T COST

Estimated project cost for the proposed activity is Rs. 45 Crore.

9.0 ANALYSIS O F PRO PO SAL The company will be generating employment with proposed enhancement activity

Indirect employment opportunity will be availed by local contractors & transporters

during operational phase of project.

Due to expansion activity environment will not be affected. In fact there will be

improvement due to use of green technology.

Noise pollution will remain under control.

The solid waste handling & disposal system is adequately defined. Thus there will not

be any adverse effect.

CSR activities company has taken up for COMMUNITY WELFARE are as under.

Community welfare & peripheral development within area. * Smt. Jayaben Mody Hospital, Ankleshwar

* Sardar Vallabhbhai Patel Hosp ital, Ank leshwar

* Rural Hospital, Jhagadiya

* Manubhai Patel Rotary Youth Centre, Bharuch

* J B Mody Fountain, Bharuch

* Development of Shantivan at Bharuch.

* J.B Mody Park, Bharuch

* Aanganwadi at Village-Kharod, Village–Bhadi, Village – Shukaltirth

* Women empowerment project in nearby villages.

Community welfare & development work in other area

1. COMMON WELFARE AREA Smt. Jayaben Mody Hall, Lion’s Community Centre, Bardoli

2. EDUCATIO NAL AREA

B K Mody Pharmacy Collage at Rajkot

B V Patel Centre for Pharma Research, Ahmedabad

3. HEALTHCARE AREA

H J Joshi Hindusabha Hospital , Ghatakopar

Smt. Sushilaben R Mehta & K K Shah Premachand Cardiac Institute, Mumbai


Page no 43

APPENDIX-I

PRO BABLE PRODUCTS FO R MANUFACTURING

(Step-I: Diclofenac Sodium)

2,6 DCP, sodium methoxide, ethyl chloro acetate, aniline caustic are added to reactor

in required proportion.The mass is allowed to react together at required temperature

and pressure condition, once the reaction is over, the material is filtered and dried in

drier and packed in drums and stored as DCDPA

(Step-II: Diclofenac Sodium )

DCDPA, ethoxy ethanol, chloro acetyl ch loride are added to a reaction vessel,

hydrogen chloride gas generated during the reaction is scrubbed off with the help of

caustic solution in scrubber tower. The material filtered, washed and dried packed and

store as CP DCA

(Step-III: Diclofenac Sodium )

CPDCA, aluminium chloride to allow react in a reactor and controlled temperature

condition. The mass is then quenched in water and filtered, hydrogen ch loride gas

generated during reaction and quenching is taken to scrubber system. Neutralized

material is f iltered, washed, dried, packed and store as Indolinone

Diclofenac Sodium (DFS) (Step IV: Diclofenac Sodium)

Indolinone, caustic and so lvent added reaction vessel, reaction is done under

controlled condition the material after reaction is over, filtered, and dried packed and

stored as DFS


Page no 44

1) Diclofenac Sodium Reaction scheme:

Cl

Cl

OH+ ClCH2COOC 2H5 +

NH2 Cl

Cl

NH

2, 6-Dichlorophenol Aniline

Ethyl Chloroacetate

Stage-01: Dichlorodiphenyl amine

+ ClCH2COCl

Chloroacetyl chloride

Cl

Cl

N

OCl

Stage-02: CPDCA

Aluminum chloride AlCl3Cl

Cl

N

O

Stage-03: Indolinone derivative

Sodium Hydroxide NaOH

Cl

Cl

NH

OO

Na

Diclofenac sodium

Mol. weight: 318

C14H10Cl2O2N.Na

C6H4OCl2Mol.wt:163

mol.wt: 122.5 C6H7NMol.wt: 93 C12H9NCl2 MOL.WT: 238

Mol. wt: 113

C14H10NCl3O Mol. wt: 314.5

C14H9Cl2NO Mol. wt:278

Stage-02

Stage-03

Stage-04

Stage-01


Page no 45

Material flow sheet: Step – 1

Qty Kgs

Input Reaction & Equipment Qty Kgs

Output

0.772 1.82 0.544 0.424 0.275 2.41

2,6 D.C.P Sodium Methoxide Soln. 25% Ethyl Chloro Acetate Aniline Caustic Lye Water

2.3 0.24 0.01 2.295 0.4

Recovery of Solvent – mix. NaCl DCP recovery Aqu. Effiuent Drying loss

Kgs Starting Material

Kgs Product Kgs Waste

0.772 1.82 0.544 0.424 0.275 2.41

2,6 D.C.P Sodium Methoxide Soln. 25% Ethyl Chloro Ace Aniline Cautic Lye Water

1.00

D.C.D.P.A 2.295 0.01 0.24 2.3 0.4

1) To ETP waste Waste water DCP recovery Sodium Chloride 2) To recovery 3) Moisture loss

6.245 Total 1.00 Total 5.245 Total

Receiver

Reactor – 101

Filter

Collection pit

Moisture Removal


Page no 46

Product: Step-II Material flow sheet

Qty Kgs

Input Reaction & Equipm ent Qty Kgs

Output

0.8 0.58 2.22

D.C.D.P.A Chloro Acetyl Chloride

Ethoxy ethanol

0.15 2.37 0.08

HCl gas to Scrubber Ethoxy ethanol recovery Drying loss


Kgs Product Kgs W aste

0.8 0.58 2.2

DCDP A Chloro Acetyl Chloride Ethoxy Ethanol

1

C.P.D.C.A 0.15 2. 37 0.08

1) HCl gas 2) To recovery 3) Drying loss

3.6 Total 1 Total 2.58 Total

Reactor – 201

Filter

Collection

Tank

Drying


Page no 47

Product: INDOLINO NE (Step-III) Material flow sheet

Qty Kgs


Output

1.12 0.656 3.7

C.P.D.C.A Aluminium Chlor ide

Water

0.149 3.977 0.35

HCl Gas PAC solution for sell Drying loss



1.12 0.656 3.7

C.P.D.C.A Aluminium Chlor ide Water

1.00

Indolinone 3.977 0.149 0.35

1) PAC solution for sell 2)HCl 3) Moisture loss


Reactor – 301

Filter

Collection

pit

Moisture removal

Quencher


Page no 48

Product: Diclofenac Sodium Material flow sheet: Diclofenac Sodium step – 4

Qty Kgs


Output

1.089 0.302 0.008 2.6

Indolinone Sodium Hydroxide Charcoal

Water

2.691 0.008 0.3

Aqu. Effiuent charcoal Moisture drying loss



1.089 0.302 2.6 0.008

Indolinone Sodium Hydroxide Water Charcaol

1

Diclofenac Sodium 2.691 0.3 0.008

1) To ETP waste water 2) Drying loss 3) Charcaol to Incineration


Reactor – 401

Filter

Collection pit

Moisture removel

Crystallizer


Page no 49

2) Nifedipine In order to prepare Nifedip ine first Methanol Acetyl Chloride (M AC) is produced in

MAC reaction vessel. The other raw material required for Nifedipine is Beneze

Derivative (BD). The BD and MAC are reacted in a Nifedipine reaction vessel.

Fitered in centrifuge after crystallization and subsequently these crystals are dried

2.1) Reaction scheme of Benzylidene derivative (BD): Interm ediate of Nifedipine:

CH3O CH3

O O

C5H8O3 Mol. w t: 116.11

+ NH3

CH3

O CH3

O NH2

+ OH2

Methyl-3-Amino Crotonate

C5H9NO2 Mol. w t: 115.13

AmmoniaMol. w t: 17.02

Water

Mol. w t: 18

Methyl acetoacetate

Methanol

Stir for 24 hourw ater

Reaction Temp.: 20°-25°C


Page no 50

2.2) Reaction scheme of 3-Methyl amino crotonate (MAC ) Intermediate of Nifedipine:

+ C7H5NO3 CH3 COCH2COOCH3

Mol wt. 151.12 Mol wt. 116.12 NO 2 O O –CH 3 O CH 3 Benzylidine derivative C 12 H 11 NO 5 M.Wt. 249


Page no 51

2.3) Reaction scheme of Nifedipine:

O CH3

O

CH3O

NO2

+ CH3O CH3

ONH2

Benzyl idine Derivative

C12H11NO 5 MW: 249 MW: 249

Methyl-3-aminocrotonate (MAC)Methyl-3-aminocrotonate (MAC)Methyl-3-aminocrotonate (MAC)

C5H9NO 2 MW: 115.13

NH

CH3 CH3

O CH3

OOCH3

ONO2

Nifedipine C17H18N2O6 MW: 3446.34 MW: 3446.34 MW: 3446.34 MW: 3446.34

Nifedipine Reaction scheme


Page no 52

Nifedipine step-I Qty Kgs


Output

1.60 1.60 1.1

Methyl Aceto Acetate Methanol Liq NH3

3 0.3

Methanol rec Drying loss

Kgs Starting Material Kgs Product Kgs W aste 1.60 1.6 1.1

Methyl Aceto Acetate Methanol Liq NH3

1 Nifedi[pine step-i

3 0.3

Methnaol recovery Drying loss

4.3 Total 1 Total 3.3 Total Nifedipine step-II Qty Kgs


Output

0.65 6.60 1.5

Methyl Aceto Acetate Methanol ONBA

3 0.3

Methanol rec Drying loss

Kgs Starting Material Kgs Product Kgs W aste 0.65 6.60 1.5

Methyl Aceto Acetate Methanol ONBA

1 Nifedi[pine step-II

6.55 0.3 0.4

Methnaol rec. Drying loss Waste water



Page no 53

Nifedipine step-III Qty Kgs


Output

0.78 1.80 5.5 3.2

Nifedipine-St ep-I Nifedipine-St ep-II Methanol Acetic acid

5.4 3.1 1.48 0.3

Methanol rec Acetic acid rec Waste water Drying loss

Kgs Starting Material Kgs Product Kgs W aste 0.78 1.80 5.5 3.2

Nifedipine-I Nifedipine-II Methanol Acetic acid

1 Nifedipine 5.4 0.3 3.1 1.48

Methnaol rec Drying loss Acetic acid rec Waste water

11.28 Total 1 Total 7.25 Total 3) Diclofenac Potassium (DFK) 2, 6 DCP, sodium Methoxide, Ethyl Chloro Acetate, An iline Caustic Are added to

reactor in required proportion.

The mass is allowed to react together at required temperature and pressure condition,

once the reaction is over, the material is f iltered and dried in dreir and packed in

drums and stored as DCDPA

DCDPA, Toluene, Chloro Acetyl chloride are added to a reaction vessel, Hydrogen

Chlor ide gas generated during the reaction is scrubbed off with the help of caustic

solution in scrubber tower. The material filtered, washed and dried packed and store

as CPDCA

CPDCA, aluminium chloride to allow react in a reactor and controlled temperature

condition. The mass is then quenched in water and filtered, Hydrogen chlor ide gas

generated during reaction and quenching is taken to scrubber system. Neutralized

material is f iltered, washed, dried, Packed and store as Indolinone

Indolinone, Caustic Potash and solvent added to reaction vessel, reaction is done

under controlled condition and so lvent recovered during the process, the material after

reaction is over, filtered dried packed and stored as DFK


Page no 54

DIC LO FENAC POTASSIUM REAC TION SCHEME:

Cl

Cl

OH+ ClCH2COOC 2H5 +

NH2 Cl

Cl

NH

2, 6-Dichlorophenol Aniline

Ethyl Chloroacetate

Stage-01: Dichlorodiphenyl amine

+ ClCH2COCl

Chloroacetyl chloride

Cl

Cl

N

OCl

Stage-02: CPDCA

Aluminum chloride AlCl3Cl

Cl

N

O

Stage-03: Indolinone derivative

Potassium Hydroxide KOH

Cl

Cl

NH

OO

K

Diclofenac Potassium

Mol. weight: 334.23

C14H10Cl2O2N.K

C6H4OCl2Mol.wt:163

mol.wt: 122.5 C6H7NMol.wt: 93 C12H9NCl2 MOL.WT: 238

Mol. wt: 113

C14H10NCl3O Mol. wt: 314.5

C14H9Cl2NO Mol. wt:278

Stage-01

Stage-02

Stage-03

Stage-04


Page no 55

Product: Diclofenac Potassium Material flow sheet: Step – 1 Qty Kgs


Output

0.82 1.82 0.544 0.424 0.275 2.41

2,6 D.C.P Sodium Methoxide Soln. 25% Ethyl Chloro Ace Aniline Caustic Lye Water

2.3 0.24 0.01 2.343 0.4




0.82 1.82 0.544 0.424 0.275 2.41


1.00

D.C.D.P.A 2.343 0.01 0.24 2.3 0.4

1) To ETP waste water DCP recovery Sodium Chloride 2) To recovery 3) Moisture loss


Receiver

Reactor – 101

Filter

Collection

pit

Moisture removal


Page no 56

Product: DFK Step-II Material flow sheet

Qty Kgs


Output

0.8 0.42 1.18 1.5

D.C.D.P.A Chloro Acetyl Chloride

Toulene Water

0.15 1.17 1.38 0.2

HCl gas to Scrubber Toluene recovery Waste water for treatment Drying loss



0.8 0.42 1.8 1.15

DCDP A Chloro Acetyl Chloride Toluene Water

1

C.P.D.C.A 0.15 1. 17 0.2 1.38

1) HCl gas 2) To recovery 3) Drying loss 4). Waste water for treatment


Reactor – 201

Filter

Collection Tank

Drying


Page no 57

Product: DFK (Step-III) Material flow sheet

Qty Kgs


Output

1.12 0.656 3.7

C.P.D.C.A Aluminium Chloride

Water

0.149 3.977 0.35




1.12 0.656 3.7

C.P.D.C.A Aluminium Chloride Water

1.00

Indolinone 3.977 0.149 0.35



Reactor – 301

Filter

Collection pit

Moisture removal

Quencher


Page no 58

Diclofenac Potassium Material flow sheet:

Qty Kgs


Output

1.09 0.38 0.009 2.4

Indolinone Potassium Hydroxide Charcoal

Water

2.57 0.009 0.3

Aqu. Effiuent Charcoal for Incineration Moisture drying loss



1.09 0.38 0.009 2.4

Indolinone Potassium Hydroxide Charcoal Water

1


2.57 0.009 0.3

1) To ETP waste water 2) Charcoal 3) Moisture loss


Reactor – 801

Filter

Collection pit

Moisture removel

Crystallizer


Page no 59

4) Product nam e: Fluconazole Epoxide compounds intermediate & 1, 2, 4 Triazole are treated in presence of potassium carbonate. Once reaction is over treated with ethyl acetate, purif ied from IPA, filtered & dried to give Fluconazole.

N

N NH+

N

NN

O

F

F

N

NN

F

F

OHN

NN

MW: 306.27

Fluconazole

1H-1,2,4-triazole

MW: 69MW: 237

Epoxide intermediate


Page no 60

PRO DUCT: FLUCONAZOLE Qty Kgs


Output

1.20 1.43 0.175 2.0 2.00 2.4 1.50

Epoxide Intermediate 1,2,4-Triazole Pottasium Carbonate Dimethyl Formide Water Ethyl Acetate Isopropyl Alcoho l

1.92 5.785 1.2 0.3

DMF recovery Aqua Eff luent IPA recovery Drying loss

Kgs Starting Material Kgs Product Kgs W aste 1.20 1.43 0.175 2.0 2.00 2.4 1.50

Epoxide Intermediate 1,2,4-Triazole Pottasium Carbonate Dimethyl Formide Water Ethyl Acetate Isopropyl Alcoho l

1.0 FLUCONAZOLE

1.92 6.285 1.2 0.3

DMF recovery Aqua Eff luent IPA recovery Drying loss



Page no 61

5) Product nam e: Ciprofloxacin Fluoro quonlinic acid & piper izine treated in presence of dimethyl sulphox ide.

Caustic lye is added, to form a base. Treated with HCl to give ciprof loxacin. Pur ified

using Methanol filtered & dried to give ciprof loxacin.

+NH

NH

Piperazine

Cl

F

N

OH

OO

Fluoro Chloro Quinolonic acid ( Q-Acid) (Intermediate for Ciprofloxacin)

MW: 281.5

N

F

N

OH

OO

NH

Ciprofloxacin MW: 331.34


Page no 62

Product: C iprofloxacin Stage-01 (Base) Material Flow Sheet:

Quantity Kgs

Inputs Reaction & Equipment Quantity Kgs

Out put

150 Q-Acid

102 Piperazine

121.5 n-Butanol 175 Caustic lye so lution 100 Conc. HCl 130 Acetic acid

4050 Water

90 Recovery of n-Butanol

Waste water

30 Evopration n-Butanol

100 Moisture drying lost

Kgs Starting Material Kgs Product Kgs Waste 150 Q-Acid 1) To ETP waste:

102 Piperazine 4458 2) Waste Water

121.5 n-Butanol 175 Caustic lye so lution

90 3) Recovery of n-Butanol

100 Conc. HCl 30 4) Recovery loss 130 Acetic acid

4050 Water

150 Ciprof loxacin stage-01 (Base)

100 5) Drying Loss 4828.5 150 Total 4678 Total

Reactor

Filter

Drying

Receiver

Collection Pit


Page no 63

Product: C iprofloxacin Stage-02 (Ciprofloxacin HCl) Material Flow Sheet:

Quantity Kgs


Out put

150 Ciprof loxacin Base stage-01

90 Conc. HCl

1020 Methanol 375 Water

1190 Recovery of methanol + water

Waste water

275 Evopration loss


Kgs Starting Material Kgs Product Kgs Waste

150 Ciprof loxacin Base stage-01

1) To ETP waste:

90 Conc. HCl 2) Waste Water

1020 Methanol 375 Water

1190 3) Recovery

275 4) Recovery loss

150 Ciprof loxacin stage-02 (Ciprof loxacin HCl)

20 5) Drying Loss

1635 Total 150 Total 1485 Total

Reactor

Filter

Drying

Receiver

Collection Pit


Page no 64

6).Product nam e- Ofloxacin: Quonalinic acid & N- methyl piperizine reacted in

butanol. The reaction mass acetic acid is added mass is neutralized to give of loxacin.

Purified, filtered & dried to give of loxacin.

Q-Acid

FO H

O O

N

OC H 3

F+

N H

NCH 3

N-Methyl Piperazine

FO H

O O

N

OC H 3

N

N

CH 3

Ofloxacin

MeOH105-110°C 105-110°C105-110°C105-110°C

MW: 361.37

MW: 280.20

9 , 1 0 -D if lu o ro - 3 - M e th y l- 7 -O x o - 2 , 3 -D ih y d r o 7 -H - P y ri d o - 1 , 2 , 3 - D E ] - 1 , 4 -B e n zo xy a z in e -6 - C a rb o x y lic A c i d

Product: O FLOXACIN Qty Kgs


Output

1.25 0.9 1.0 0.3 0.45

Quinolic Acid N-Methyl Piperazine Butanol Acetic Acid Liq. Ammonia

0.95 1.95 0.35

Butanol recovery Aqu Effluent Drying loss


Filter & dry Solid


Page no 65

1.25 0.9 1.0 0.3 0.45

Quinolic Acid N-Methyl Piperazine Butanol Acetic Acid Liq. Ammonia

1.0 Ofloxacin 1.95 0.35 0.95

1) To ETP waste water 2) Dry loss 3) Butanol recovery

3.9 Total 1.0 Total 2.9 Total 7).Product nam e: Levetirecetam

L- 2- amino butyric acid reacted with thionyl chloride. Neutralized with ammonia,

treated with 4- chloro butyl chloride. The mass is crystallized from water, filtered &

dried to give leveticetam.

O

CH3

NH2OH

+ ClCl

O

4-Chlorobutyryl chlorideL(+)-2-Aminobutyric acid

MW: 103.12 MW: 141

N CH3

CH3

O

Levetriracetam

MW: 170.21


Page no 66

LEVITIRACITEM 1.45 0.85 1.12 0.35 1.79

L-2- amino butyric acid Thionyl chloride Ammonia 4-Chloro butyl ch loride Water

1.73 2.60 0.23

Butyric acid recovered Aqu. Effluent Drying loss

Kgs Starting Material Kgs Product Kgs W aste 1.45 0.85 1.12 0.35 1.79

L-2- amino butyric acid Thionyl chloride Ammonia 4-Chloro butyl ch loride Water

1.00 Levetiracetam 1.73 2.60 0.23

Butyric acid recovery Aqu. Effluent Drying loss


Purification

Drying, Milling Sifting


Page no 67

8).Product nam e: Lostaran Potassium 2-Butyl-4 chloro-5 hydroxy methyl imidazole reacted with 4-bromomethyl-2-cyanobiphenyl & Na Methoxide. Further treated with sodium azide & NH4 Cl in presence of DMF. The mass is crystallized from methanol to give lostaran potassium Reaction schem e:

N

NH

CH3

Cl

OH

2-Butyl-4 chloro-5 hydroxy methyl imidazole

+

MW: 188.65

4-bromomethyl-2-cyanobiphenyl

Br

N

MW: 272.14

NaN3

CH3ONa

NN

NH

N

N

N

CH3

ClKO

Losartan Potassium

MW: 461.01

KOH


Page no 68

Product: Losartan potassium (Material flow sheet) Qty Kgs


Output

1.95 1.01 3.1 0.35 0.21 2.32 2.79

2-Butyl-4 chloro-5 hydroxy methyl imidazole 4-bromomethyl-2- cyanobipheny l Na Methoxide Sodium azide NH4 Cl DMF Methanol

2.48 2.18 3.43 2.51 0.13

Methanol recovery DMF recovery Effluent treatment (Methanol recovery) Drying loss


2-Butyl-4 chloro-5 hydroxy methylimidazole 4-bromomethyl-2- cyanobipheny l Na Methoxide Sodium azide NH4 Cl DMF Methanol + water

1.00 Losartan potassium 2.48 2.18 3.43 2.51 0.13

Methanol mix recovery DMF recovery Effluent treatment (Methanol recovery) Drying loss


Purification

Drying, Milling, Sifting


Page no 69

9).Product nam e: Lisinopril N-[N2-Benzyloxycarbonyl-N6-tertiarybutoxycarbonyl-Lysyl]-L-Praline benylester Hydrogenated with Catalyst Hydrogenated & Water. The mass is further treated with 2-Oxo-4 Phenyl Butyric acid & Sodium Hydroxide. The resultant mass is crystallized from Methanol to yield Lisinopril.

OH

O

O

2-Oxo-4-phenylbutyric acid

MW: 178.8

+N

OH

O

NH2

ONH2

N-[N2-Benzyloxycarbonyl-N6-tertiarybutoxycarbonyl-Lysyl]-L-Praline benylester

N

OH

O

NH2

ONH

OHO

Lisinopril

MW: 441.52

NaOH


Page no 70

Product: Lisinopril (Material flow sheet): Qty Kgs


Output

1.36 0.12 2.1 0.8 1.1 2.33

N-[N2-Benzyloxycarbonyl- N6-tertiarybutoxycarbonyl- Lysyl]-L-Praline benylester Catalyst Hydrogenated Water 2-Oxo-4 Phenyl Butyric acid Sodium Hydroxide Methanol

2.49 1.98 2.24 0.1

Aqueous effluent for catalyst recovery Aqu. Liquid for Fe acetate recovered (Methanol recovery) Drying loss

Kgs Starting Material Kgs Product Kgs W aste 1.36 0.12 2.1 0.8 1.1 2.33

N-[N2-Benzyloxycarbonyl- N6-tertiarybutoxycarbony l- Lysyl]-L-Praline benylester Catalyst Hydrogenated Water 2-Oxo-4 Phenyl Butyric acid Sodium Hydroxide Methanol

1.00

Lisinopril

2.49 1.98 2.24 0.1

Aqueous effluent for catalyst recovery Aqu. Effluent for Fe. Acetate recovered Mother liquor (methanol recovery) Drying loss



Purification


Page no 71

10).Product name: Levocetrizine 1-[4-Chlorophenyl) pheny lmethyl] piperizine is treated with L-Tartaric acid, (2-Chloroethoxy) & Acetonitrile. The mass is further treated with Sodium Carbonate, KI, .n-Butanol & Conc. HCl. The crude obtained is crystallized from ethyl acetate to give levocetrizine.

N

NH

Cl

+ O

OH

O

Cl

L-Tartaric acid,(2-Chloroethoxy) 1-[4 -Chlorophenyl)phenylmethyl]piperizine

N N

Cl

O

OH

O

Levocetirizine HCl

.HCl

HCl

Na 2CO3


Page no 72

Material flow sheet:

Qty Kgs


Output

1.82 0.62 1.45 0.35 0.15 2.25 0.32 2.95

1-[4- Chlorophenyl)phenylmeth yl]piperizine L-Tartaric acid (2-Chloroethoxy) Acetonitrile Sodium Carbonate Kl N-Butanol Conc. HCl E. Acetate

0.12 2.08 3.92 2.66 0.13

Solvent lo ss N-Butanol reco. Aqu. Effluent for Kl & Tartaric acid recovery E. Acetate recovery Drying loss

Kgs Starting Material Kgs Product Kgs Waste 1.82 0.62 1.45 0.35 0.15 2.25 0.32 2.95

1-[4Chlorophenyl) phenylmethyl]piperizine L-Tartaric acid (2-Chloroethoxy) Acetonitrile Sodium Carbonate Kl N-Butanol Conc. HCl E. Acetate

1.0 Levocetirizine

0.12 2.08 3.92 2.66 0.13

Solvent lo ss N-Butanol reco. Aqu.Effluent for Kl & Tartaric acid recovery E. Acetate recovery Drying loss


Purification

Crude Levocetirizine



Page no 73

11). Product name: Ropinrole 3-Chloro-4-[Carbonyl oxophenyl) ethyl]-1, 3-dihydro-2-H-2-Indolinone hydrogenated using Palladium Hydrogen catalyst, neutralized with Caustic lye. The mass is treated with N, N dipropylamine in Methanol. The crude obtained is crystallized from IPA to give Ropinrole.


Page no 74

NH

O+CH3

NCH3

Cl

1,3-dihydro-2H-indol-2-one

H2

NaOH

CH3

NCH3

NH

O

N-(2-chloroethyl)-N-propylpropan-1-amine

Ropinirol

MW: 296.84

CH3

NCH3

NH

O

HCl

Ropinirol Hydrochloride

HCl

Material flow sheet:

Qty Kgs


Output

2.1

3-Chloro-4-[Carbonyl oxophenyl)ethyl]-1,3- dihydro-2-H-2-Indolinone


Page no 75

0.12 0.45 0.95 2.45 2.0

Palladium Hydrogen Caustic lye N,N dipropylamine Methanol IPA

2.7 0.12 2.22 1.89 0.14

Aqu. Effluent For Palladium recovery To effluent Methanol recovery IPA recovery Drying loss

Kgs Starting Material Kgs Product Kgs Waste 2.1 0.12 0.45 0.95 2.45 2.0

3-Chloro-4-[Carbonyl oxophenyl)ethyl]-1,3- dihydro-2-H-2-Indolinone Palladium Hydrogen Caustic lye N,N dipropylamine Methanol IPA

1.0 Ropinro le 2.7 0.12 2.22 1.89 0.14

Aqu. Effluent For Palladium recovery To effluent Methanol recovery IPA recovery Drying loss

8.07 Total 1.0 Total 7.07 Total 12). Product name: Atorvastatin Calcium (2R-trans)-5-(4-Fluorophenyl)-2-(1-Methyl)-N,4diphenyl-1-[2-Tetra hydroxy-4hydroxy-6-Oxo-2H-pyran-2-yl)ethyl]-1H-pyrrole-3-carboxamide treated with NaOH in IPA. The mass is treated with calcium acetate solution. The crude obtained is crystallized from IPA to give atorvastatin calcium.


Page no 76

ATO RVAS TATIN CALC IUM reaction schem e:-

NH N

O CH3 CH3O

OH

OHOH

F

NaOH

NH N

O CH3 CH3 O

O

OHOH

F

Na

Calcium acetate

NH N

O CH3 CH3O

O

O HO H

F

K

Atorv astatin Calsium

MW: 1155.36

(2R-trans)-5-(4-F luorophenyl)-2-(1-Methyl)-N ,4diphenyl-1-[2-Tetra hydroxy -4hydroxy-6-Oxo -2H-pyran-2-y l)ethy l]-1H -pyrro le-3-carboxamide

Product: Atorvastatin Calcium (Material flow sheet): Qty Kgs


Output

1.91

(2R-trans)-5-(4-Fluoropheny l)-2-(1-

3.58

Aqueous


Page no 77

2.25 0.31 1.4 1.73

Methyl)-N,4diphenyl-1-[2- Tetra hydroxy-4-hydroxy-6-Oxo-2H-pyran-2-yl)ethyl]- 1H-pyrrole-3-carboxamide IPA NaOH Calcium acetate solution IPA

1.28 2.24 0.1

effluent for IPA recovery Aqu. Liquid for Ca acetate recovered Mother liquor (IPA recovery) Drying loss


2R-trans)-5-(4- Fluoropheny l)-2-(1- Methyl)-N,4diphenyl-1-[2- Tetra hydroxy-4-hydroxy-6-Oxo-2H-pyran-2 yl)ethyl]- 1H-pyrrole-3-carboxamide IPA NaOH Calcium acetate solution IPA

1.00 Atorvastatin Calcium

3.58 1.28 2.24 0.1

Aqueous effluent for IPA recovery Aqu. Liquid for Ca acetate recovered Mother liquor (IPA recovery) Drying loss

7.6 Total 1.00 Total 6.6 Total 13).Product name: Clopidogril Sulphate Amino Ester (VIII) (+)-10-Camphorsulphonic acid reacted with Formic acid & Formaldehyde. The mass is treated with Sulphuric acid, IPA + Water. The crude obtained is crystallized using water + Methanol, filtered, and dried to give Clopidogril Sulphate.



Page no 78

Clopidogril Bisulphate reaction schme:

NS

Cl

HCHO

HCOOH

NS

Cl

OO CH3

7-(2-chlorobenzyl)-2-thia-7-azaspiro[4.5]dec-3-ene

Clopidogrel BiSulfate

H2SO4

MW: 419.90 Material flow sheet: Qty Kgs


Output

2.82 Amino Ester


Page no 79

1.85 0.33 1.17 1.5 0.25 + 1.2

(VIII) (+)-10-Camphorsulphonic acid Formic acid Formaldehyde Sulphuric acid IPA + Water Water + Methanol

0.12 2.48 4.05 1.36 0.11

Solvent lo ss IPA reco. Aqu. Effluent Methanol + water recovery Drying loss

Kgs Starting Material Kgs Product Kgs W aste 2.82 1.85 0.33 1.17 1.5 0.25 + 1.2

Amino ester (VIII) (+)-10-Camphorsulpho ic acid Formic acid Formaldehyde Sulphuric acid IPA + Water Water + Methanol

1.0 Clop idogril Bisulphate

0.12 2.48 4.05 1.36 0.11

Solvent lo ss IPA Reco. Aqu. Effluent Methanol + Water recovery Drying loss

9.12 Total 1.0 Total 8.12 Total 14).Product name: Sertraline HCl 4-(3, 4-Dich lorophenyl)-3, 4-dihydro-1(2H)-naphthalene, Methyl amine Lewis acid & Hydrogen; D (-) Mandelic acid with Conc. HCl. The crystallized from Methanol + Water, filtered & dr ied to give Steraline HCL.

Purification

Crude Clopidogril Bisulphate



Page no 80

Cl

Cl

NH CH3H

H

HCl

Cl

Cl

NH CH3H

H

. HCl

(1S,4S)-4-(3,4-dichlorophenyl)-N-methyl-1,2,3,4-tetrahydronaphthalen-1-amine

Setral ine HClMW: 342.70

Qty Kgs


Output 1.42

4-(3,4-Dich lorophenyl)- 3,4-dihydro-1(2H)-

Reactor


Page no 81

15).Product name: Oxcabazepine 5H-Dibenz[b,f]azep ine-5- carbonitrile ; Sodium nitrite treated in presence of Acetic acid & Iron

0.37 0.29 0.16 0.85 3.5 1.2

naphtholene Methyl amine Lewis acid Hydrogen D (-) Mandelic acid Conc. HCl Methanol + Water

` 2.24 4.46 0.09

Aqu. Effluent for Mandelic acid recovery Methanol + water recovery Dryi`ng loss


4-(3,4-Dich lorophenyl)- 3,4-dihydro-1(2H)- naphtholene Methyl amine Lewis acid Hydrogen D(-) Mandelic acid Conc. HCl Methanol + Water

1.0 Sertraline. HCl 2.24 4.46 0.09

Aqu. Effluent for Mandelic acid recovery Methanol + water recovery Drying loss


Reactor

Purification

Crude Sert raline HCl



Page no 82

Boron Trifluoride is added. The mass is filtered to give crude product, crystallized from IPA, filtered & dried to give Oxcabazepine.

N

O

ClO

N

O

NH2O

NH4OH

10-oxo-10,11-dihydro-5H-dibenzo[b,f]azepine-5-carbonyl chloride

Oxcarbazepine

MW: 252.27 Product: O xcarbazepine Material flow sheet: Qty Kgs


Output


Page no 83

1.35 0.08 1.1 0.35 2.25

5H-Dibenz [b,f]azep ine-5- carbonitrile Sodium nitrite Acetic acid Iron Acetic acid Boron Trifluoride IPA

2.79 1.75 2.02 0.1

Aqueous effluent for Sod. Ace. recovery Aqu. Liquid for Fe acetate recovered Mother liquor (IPA recovery) Drying loss


5H-Dibenz[b,f]azep ine-5- carbonitrile Sodium nitrite Acetic acid Iron Acetic acid Boron Trifluoride IPA

1.00 Oxcarbazepine 2.79 1.75 2.02 0.1

Aqueous effluent for Sod. Ace. Recovery Aqu. Effluent for Fe. Acetate recovered Mother liquor (IPA recovery) Drying loss

7.6 Total 1.00 Total 6.6 Total 16).Product name: Midazolam & derivative 2-(2’-aminomethyl Carbonyl Methoxy)-7- Ch loro-5-(2-Fluoro Phenyl)-1, 3-dihydro-2H- 1, 4-benzodiazepine & Triethyl orthoacetate treated, hydrolysed with NaOH. Further neutralized with Conc. HCl. The crude product obtained is crystallized from Methanol + Water. Filtered, dr ied to give MIDAZOLAM.


Purification


Page no 84

NH

ClF

N

NH2

1-[7-chloro-5-(2-f luorophenyl)-2,3-dihydro-1H-1,4-benzodiazepin-2-yl]methanamine

CH3C(OC2H5)3

Cyclization

N

ClF

N

N Me

8-chloro-6-(2-f luorophenyl)-1-methyl-3a,4-dihydro-3H-imidazo[1,5-a] [1,4]benzodiazepine

Dehydrogenation

N

ClF

N

N Me

8-chloro-6-(2-fluorophenyl)-1-methyl-4H-imidazo[1,5-a][1,4]benzodiazepine

(MIDAZOLAM)

Triethyl orthoacetate

MW: 325.77 Product: Midazolam. HCl Material flow sheet: Qty Kgs


Output


Page no 85

1.89 1.12 0.27 1.09 3.2

2-(2’-aminomethyl Carbony l Methoxy)-7- Chloro-5-(2-Fluoro Phenyl)-1,3-dihydro-2H- 1,4-benzodiazepine Triethyl orthoacetate NaOH Conc. HCl Methanol + Water

2.21 1.3 2.95 0.11

M/L for Recovery of T.E.O Aqu. Effluent Mother liquor (Methanol recovery) Drying loss


2-(2’-aminomethyl Carbony l Methoxy)-7- Chloro-5-(2-Fluoro Phenyl)-1,3-dihydro-2H- 1,4-benzodiazepine Triethyl orthoacetate NaOH Conc. HCl Methanol + Water

1.00 Midazolem. HCl 2.21 1.3 2.95 0.11

M/L for Recovery of T.E.O Aqu. Effluent Mother liquor (Methanol recovery) Drying loss


17). Product name : Nebivolo l Benzopyran-2-Carboxaldehyde Derivative treated with Trimethyl sulfoxon ium iodide In presence of Potassium hydroxide & Water. The mass is further treated with Benzyl


Purification


Page no 86

amine & Toluene, Ammonium formate using Pd/Catalyst. The mass is crystallized from Methanol, filtered & dried to give Nebivolol.

O

F

OO

F

O

T rimethyl sulphoxonium iodide

KOH

NH2

O

F

NHOH

Benzyl amine

6-f luoro-3,4-dihydro-2H-chromene-2-carbaldehyde

O

F

O

O

F

N

OH

O

F

OH

HCOONH2 Toluene

O

F

NH

OH

O

F

OH

Benzyl nebivolol Nebivolol

MW: 405.43 Product: Nebivolol Material flow sheet: Qty Input Reaction & Equipm ent Qty Output


Page no 87

Kgs Kgs 1.4 1.15 0.56 3.0 0.4 3.0 0.6 0.01 1.2 4.0

Benzopyran-2- Carboxaldehyde Derivative Trimethyl sulfoxonium iodide Potassium hydrox ide Water Benzyl amine Toluene Ammonium formate (Hydrogen source) Pd/C Methanol Methanol

5.3 4.6 3.0** 0.3 0.4

Aqueous effluent Methanol (recover) à recycle Toluene Recovery à recycle Drying loss Carbon dioxide

Kgs Starting Material Kgs Product Kgs Waste 1.4 1.15 0.56 3.0 0.4 3.0 0.6 0.01 5.2

Benzopyran-2- Carboxaldehyde Deri Trimethyl sulfoxonium Iodide Potassium hydrox ide Water Benzyl amine Toluene Ammonium formate (Hydrogen source)Pd/C Methanol

1.00 Nebivo lol 5.3 4.6 0.7 3.0 0.3 0.4

Aqueous effluent for KI (1.1 Kg) recovery Methanol Solvent lo ss Toluene Recovery Drying loss Carbon dioxide

15.32 Total 1.0 Total 14.32 Total 18).Product name: Bicalutamide 2-Cyano-4-amido benzo trifluoride is treated with Hydrogen peroxide & Water. The mass is treated with 4-Fluorobenzenethiol, Hydrogen peroxide & Acetic acid. The crude obtained is crystallized from IPA to give Biclutamide.

Protected Nebivo lol

Nebivo lol

Purification



Page no 88

NH2CF3

NC + CH3

OH

CH3O

S+

O

O

F

NaOH

CF3

NC

NH

CH3

OH

O

S+

O

O

F

2-Cyano-4-amido benzo trifluoride 4-Fluorobenzenethiol

Bicalutamide

MW: 430

H2O2

Acetic acid

MW: 186MW: 280.5

Material flow sheet: Qty Kgs


Output


Page no 89

3.85 0.12 2.85 0.95 0.18 1.1 2.25

2-Cyano-4-amido benzo trifluoride Hydrogen peroxide Water 4-Fluorobenzenethiol Hydrogen peroxide Acetic acid IPA

3.7 0.02 4.39 2.09 0.10

Aqu. Effluent To ETP Acetic acid recovery IPA recovery Drying loss

Kgs Starting Material Kgs Product Kgs Waste 3.85 0.12 2.85 0.95 0.18 1.1 2.25

2-Cyano-4-amido benzo trifluoride Hydrogen peroxide Water 4-Fluorobenzenethiol Hydrogen peroxide Acetic acid IPA

1.00 Bicalutamide 3.7 0.02 4.39 2.09 0.10

Aqu. Effluent To ETP Acetic acid recovery IPA recovery Drying loss


19). Gadopentatic acid: Gadonium Oxide is treated with DTPA, mass is dried to give Gadopentatic acid

Purification

Crude Bicalutamide



Page no 90

NN N

C O O H

C O O H

C O O H

H O O C

H O O C

NN N

C O O

C O O H

C O O

H O O C

O O C

O H 2

G d 2 O 3

+

W a t e r 9 5 0 C

G d 3 +

_

_

_

( M . W . 3 6 2 . 5 )

( M . W . 3 9 3 . 2 5 )2

+

( M . W . 5 4 7 . 5 8 )

G a d o p e n t e ti c A c id

D ie t h y l e n e t r i a m i n e P e n t a a c e t ic A c i d ( D T P A )

G a d o l i n i u m ( I I I ) O x id e

2

( M . W . 1 8 )

3

Product: gadopentetic acid Material flow sheet: Qty Kgs


Output

1.47 0.68 4.0 0.5

DTPA Gadolinium oxide Water IPA

1.25 0.025 3.37 0.45 0.45

Aqueous Effluent Insoluble solid water recovered Mother liquor (IPA recovered) Drying loss

Kgs Starting Material Kgs Product Kgs Waste 1.47 0.68 4.0 0.5

DTPA Gadolinium oxide Water IPA

1.00 Gadopentetic acid

1.25 3.37 0.45 0.1 0.025 0.45

waste water Water Recov IPA recovery Solvent lo ss Insolubleso lid Drying loss

6.645 Total 1.00 Total 5.645 Total 20).Gadodiamide; Gadonium Oxide is treated with Diethanolamine. The mass is allow to reflux, cooled & filtered to give Gadodiamide Product: Gadodiamide

Chelation & water evaporation

Purification



Page no 91

NH 2CF3

NC + CH 3

O H

CH 3O

S+

O

O

F

NaOH

CF3

NC

NH

CH 3

O H

O

S+

O

O

F

2 -C y a n o -4 -a m i d o b e n z o tr if l u o r i de 4-Fluorobenzenethiol

Bicalutamide

MW: 430

H2O2

Acetic acid

MW: 186MW: 280.5

Material flow sheet: Qty Kgs


Output

1.47 0.68 4.0 0.5

DTPA anhydride Gadolinium oxide Water IPA

1.25 0.025 3.37 0.45 0.45

Aqueous Effluent Insoluble so lid water recovered Mother liquor (IPA recovered) Drying loss

Kgs Starting Material Kgs Product Kgs W aste 1.47 0.68 4.0 0.5

DTPA anhydride Gadolinium oxide Water IPA

1.00 Gadodiamide

1.25 3.37 0.45 0.1 0.025 0.45

Waste water Water Reco. IPA recovery Solvent lo ss Insoluble so lid Drying loss

6.65 Total 1.00 Total 5.65 Total 21). Product name: Pioglitazone HCL 5 Ethyl 2 Pyridyl ethanol; Toluene; 4-Hydroxy Benzaldehyde & Sodi. Boro hydroxide with K2CO3 & Thiozolidinone in presence Caustic lye. The crude is crystallized with IPA to give Pioglitazone.

Chelation & water

evaporation

Purification



Page no 92

N OH

CH3

+OH

O

H

N O

CH3 O

H

S

NH

O

O

N O

CH3

S

NH

O

O

N O

CH3

S

NH

O

O

2-(5-ethylpyridin-2-yl)ethanol 4-hydroxybenzaldehyde

4-[2-(5-ethylpyridin-2-yl)ethoxy]benzaldehyde

1,3-thiazolidine-2,4-dione

Pioglitazone HCl

HCl

MW: 390.5

MW: 151MW: 122

Product: Pioglitazone Qty Kgs


Output


Page no 93

1.10 0.86 1.06 1.2 0.20 1.48 0.7 2.50

5 Ethyl 2 Pyridyl ethanol Toluene 4-Hydroxy Benzaldehyde Sodi. Borohydroxide K2 CO3 Thiozolidinone Caustic lye IPA

4.81 0.82 2.35 0.12

Effluent Toluene recovery IPA recovery Drying loss

Kgs Starting Material Kgs Product Kgs Waste 1.10 0.85 1.06 1.2 0.20 1.48 0.7 2.50

5 Ethyl 2 Pyridyl ethanol Toluene 4-Hydroxy Benzaldehyde Sodi. Borohydroxide K2 CO3 Thiozolidinone Caustic lye IPA

1.0 Pioglitazone 4.81 0.82 2.35 0.12

Aqueous effluent Toluene recovery IPA recovery Drying loss

9.1 Total 1.00 Total 8.1 Total 22).Product name: FEXOFENADINE Sod. Borohydride; KI; Intermediate -8 treated in presence MIBK. The mass is further treated Azycyclonol & Denatured Spir it. The mass is treated with K2 CO3. The crude is crystallized from Methanol to give Fexofenadine.


Page no 94

OOH

O

O

CH3 CH3CH3

+

NH

OH

N

OH

OH

O

O

CH3CH3CH3

K2CO3

N

OH

OH

OH

O

CH3CH3

Sodium Borohydride

NaBH4

Fexofenadine

MW: 501.65 Qty Kgs


Output


Page no 95

1..2 0.28 1.11 2..85 0.60 1. 0 4.2 3.50

Sod. Borohydride KI Intermediate -8 MIBK Azycyclonol Denat ured Spirit Water +K2CO3 Methanol

9.74 3.70 0..3

Aqu. Effluent Mother liquor Drying loss



1..2 0.28 1.11 2..85 0.60 1.0 4.2 3.50

Sod. Borohydride KI Intermediate -8 MIBK Azycyclonol Denat ured Spirit Water Methanol

1.00 Fexofenadine 9. 74 3. 70 0.3

Aqu. Effluent Mother liquor Drying loss

14.74 Total 1.00 Total 13.74 Total 23).Product name: Citalopram


Purif icat ion


Page no 96

5-Bromophthalide, CuCN & 4-Fluorophenyl Mg-bromide in THF treated. The mass is further treated with dimethylaminopropyl magnesium chloride, NaOH, DMF .The resultant mass is further treated with Phosphoric acid & HCl, Crystallized from water to give Citalopram

O

Br

O

+F

MgBr

+Cl

Mg N

CH3

CH3

THF

NC

F

OHOH

N

CH3

CH3

H3PO4

NC

F

N

CH3

CH3

O

CuCN

HCl

Water

Citalopram HBr

MW: 405.31

5-Bromophthalide 4-Fluorophenyl Mg-bromide dimethylaminopropyl magnesium chloride

Citalopram


Page no 97

Material Flow Sheet & Material Mass Balance

Stage:1 (4-Brom o-2-hydroxymethyl) 4-phenyl-(4-fluoropheny1)-(3-dimethylaminopropy1)-methanol HCl

Quantity Input Raw Materail Reaction & Equipm ent Quantity Output Kgs Kgs

0.84 5-Bromophthalide

0.42 CuCN

4.62 4-Fluorophenyl Mg-bromide in THF

3.69 Na OH

Reactor

3.2 dimethylaminopropyl magnesium

chloride

1.34 DMF 1.1 Solvent recycle

6.0 toluene Extraction 5.8

Solvent Recycle &

3.36 Phosporic acid reuse 1.68 HCl solution 30%

filtration 19.95

Waste for treatment

2.0 water drying 0.30 Drying loss


0.84 5-Bromophthalide 1.7 Citalopram HBR 6.9 Solvent Recycle &

4.62 4-Fluorophenyl Mg-bromide in THF reuse

3.2 dimethylaminopropyl magnesium chloride 19.95

Waste for treatment

6.0 toluene 1.68 HCl solution 30% 0.30 Drying loss 2.0 water

3.69 NaOH 0.42 Cu CN 3.36 Phosphoric acid 1.34 DMF



Page no 98

24). Iohexol/Iopam idol/iodixanol BRIEF MANUFAC TURING PROC ESS O F IOPAMIDO L AND INTERMEIDATES: IOPAMIDOL: STAGE-01 (ATP): 5-Amino isophthalic acid is reacted with previously prepared KICl2 (prepared from iodine monochloride and potassium chloride) to yield 2, 4, 6-Triiodo-5-amino isophthalic acid (Iopamidol stage-01). STAGE-02 (ATD): 2, 4, 6-Triiodo-5-amino isophthalic acid (stage-01) is converted to acid dichlor ide by reaction with thionyl chloride in dichloromethane. After reaction workup using ethyl acetate so lvent to extract product and finally after ethylacetate distillation product isolated in toluene. STAGE-03 (ATA): 2, 4, 6-Triiodo-5-amino isophthalic acid dichloride ( stage-02) is reacted with Acetoxy propionyl chloride in dimethyl acetamide to yield L-5-(2-acetoxypropionylamino)-2, 4, 6-triiodo isophthalic acid dich loride ( stage-03) which is extract in ethylacetate and finally after ethyl acetate distillation product isolated in toluene. STAGE-04 (ATS): L-5-(2-acetoxypropionylamino)-2, 4, 6-triiodoisophthalic acid dichloride ( stage-03) is reacted with Ser inol in presence of dimethyl acetamide to yield L-5-(2-acetoxypropionylamino)-2, 4, 6-triiodo isophthalic acid bis-(1, 3-dihydroxypropy lamide) stage-04 which is finally iso lated in Methanol + IPA mixture. STAGE-05 (IOPAMIDOL FINAL): L-5-(2-acetoxypropionylamino)-2, 4, 6-triiodoisophthalic acid bis-(1, 3-dihydroxypropy lamide) (stage-04) is hydrolyzed in aq. Ammonium hydrox ide to yield Iopamido l. IOHEXOL: 5-amino – N, N (2, 3 Dihydroxy propyl & isophthalamide TRIIODO DERIVATIVE treated with 3-Chloro, 2 –propanediol. The product is cryatallized from IPA, filtered & dried togive, Iohexol

IOPAMIDOL:-


Page no 99

Iopamidol Reaction Scheme:

NH2 I

II

O Cl

OCl

NHI

II

O NH

ONH

OH

OH

OH

OH

O

OH

CH3H

IOPAMIDOL

Serinol

NH2

O

O

OH

OH

SOCl2

5-amino-2,4,6-triiodoisophthaloyl dichloride

I

II

NH2

O

O

OH

OH

5-amino-2,4,6-triiodoisophthalic acid5-amino isophthalic acid

NHI

II

O Cl

OCl

O

OCH3

H

OCH3

L-Acetoxy propionyl chloride

ICl

25% NH3

NHI

II

O NH

ONH

O

OCH3

H

OCH3

OH

OH

OH

OH

Step-01

Step-02

Step-03

Step-04

Step-05

Mol wt: 777.01

Acetoxy compound

Condensed serinol compound

IOHEXO L


Page no 100

NH2I

II

O Cl

OCl

5-amino-2,4,6 -triiodoisoph thaloyl d ichlo ride

Mol wt: 821.14

Acetyl compound

IPA

Iohexol

NH2 OHO H

CH3COCl

NHI

II

O Cl

OCl

OCH3

NHI

II

O NH

ONH

OHOH

OHOH

CH3O

3-aminopropane-1 ,2 -d iol

NI

II

O NH

ONH

OHO H

OHOH

CH3O

OH

O H

Cl O HOH


Page no 101

Material flow sheet: Product: Iopamidol Stage-01 (ATP)

Quantity Kgs


Out put

150 5- amino isophthalic acid

404 Iodine-

monochloride 398 Potassium chloride

20 Sodium bisulphite 6850 Water

7382 Waste water


Kgs Starting Material Kgs Product Kgs Waste 150 5- amino

isophthalic acid 1) To ETP waste:

404 Iodine- monochloride

7382 Waste Water

398 Potassium chloride 20 Sodium bisulphite

6850 Water 2) To Recovery

400 Iopamidol stage-01 (ATP)

40 3) Moisture Loss 7822 Total 400 Total 7422 Total

Product: Iopamidol Stage-02 (ATD)

Reactor

Filter

Drying

Receiver

Collection Pit


Page no 102

Material Flow Sheet:

Quantity Kgs


Out put


70 Triethylamine

665 Methylene Dich loride

247 Thionyl chloride 2153 Ethyl acetate

75 Sodium bicarbonate 110 Sodium chloride 348 Toluene

1410 Purified water

795 1938 310

MDC +thionyl Recovery Ethyl acetate Recovery Toluene Recovery from ml

1665 Waste water

560 Recovery loss

10 drying lost

Kgs Starting Material Kgs Product Kgs Waste 200 Iopamidol stage-01

(ATP) 1) To ETP waste:

70 Triethylamine 1665 Waste Water

665 Methylene Dich loride

3043 2) To Recovery

247 Thionyl chloride 10 3) Drying Loss 2153 Ethyl acetate 380 4) Recovery loss

75 Sodium bicarbonate

180 Iopamidol stage-02 (ATD)

110 Sodium chloride 348 Toluene

1410 Purified water


Reactor

Filter

Drying

Receiver

Collection Pit


Page no 103

Product: Iopamidol Stage-03 (ATA) Material Flow Sheet:

Quantity Kgs


Out put


126 L -2- Acetoxy propionyl chlor ide

188 N, N’-Dimethyl acetamide

1794 Ethyl acetate 80 Sodium bicarbonate


4300 Purified water

1615 157

Ethyl acetate Recovery Toluene Recovery from ml

4733 Waste water

186 Recovery loss

10 drying lost



1) To ETP waste:


44859 Waste Water


1772 2) To Recovery

1794 Ethyl acetate 10 3) Drying Loss 80 Sodium bicarbonate 186 4) Recovery loss

165 Sodium chloride

200 Iopamidol stage-03 (ATA)

174 Toluene

4300 Purified water 7027

Total 200 Total 7027 Total

Reactor

Filter

Drying

Receiver

Collection Pit


Page no 104

Product: Iopamidol Stage-03 (ATA) Material Flow Sheet:

Quantity Kgs


Out put




1794 Ethyl acetate 80 Sodium bicarbonate


4300 Purified water

1615 157

Ethyl acetate Recovery Toluene Recovery from ml

4859 Waste water

186 Recovery loss

10 drying lost


200 Iopamidol stage-02(ATD)

1) To ETP waste:


4859 Waste Water


1772 2) To Recovery

1794 Ethyl acetate 10 3) Drying Loss 80 Sodium bicarbonate 186 4) Recovery loss

165 Sodium chloride


174 Toluene

4300 Purified water 7027

Total 200 Total 7027 Total

Reactor

Filter

Drying

Receiver

Collection Pit


Page no 105

Product: Iopamidol Stage-04 (ATS) Material Flow Sheet:

Quantity Kgs


Out put


65 Serino l

104 Triethylamine


1027 Methanol 1896 IPA

20 Purified water

1355 2631

N, N’-Dimethyl acetamide Recovery Methanol + IPA Recovery from ml

100 Waste solid

511 75

Recovery loss TEA.HCl salt

10 drying lost



1) To ETP waste:

65 Serino l 100 Waste solid

104 Triethylamine 3986 2) To Recovery


10 3) Drying Loss

1027 Methanol 511 4) Recovery loss 1896 IPA

210 Iopamidol stage-04 (ATS)

20 Purified water


Reactor

Filter

Drying

Receiver

Collection Pit


Page no 106

Product: Iopamidol Stage-05 (Final) Material Flow Sheet:

Quantity Kgs


Out put


300 Ammonia solution 25%

395 Methanol 553 IPA

2220 Purified water

854 2268

Methanol + IPA Recovery from ml Water recovery

0 Waste solid

346

Recovery loss

10 40

drying lost Residue



1) To ETP waste:

300 Ammonia solution 25%

2268 Waste recovery

395 Methanol 854 2) To Recovery 553 IPA 10 3) Drying Loss

2220 Purified water 346 4) Recovery loss

150 Iopamidol stage-05 (Final)

40 5) Residue


Reactor

Filter

Drying

Receiver

Collection Pit


Page no 107

25). Product: Pantoprazole & derivative 5-(dif louromethoxy)-1H-benziamidazole-2-thiol treated with 2-(chloromethyl)-3,4-dimethylpyridine, the resulatant mass is hydro lyzed with Sodium hydroxide & purif ied, filtered , washed & dried to give Pantoprazole Sodium deri.

NH

NO

F

F

SH +N

Cl

CH3CH3

5-(difluoromethoxy)-1H-benzimidazole-2-thiolMW: 216 MW: 187.5

2-(chloromethyl)-3,4-dimethylpyridine

N

CH3CH3

NH

NO

F

F

S

(O)

N

CH3CH3

NH

NO

F

F

S

O

Pantoprazole

MW: 383.37

NaOH

N

CH3CH3

N

NO

F

F

S

O

Na

Pantoprazole sodiumMW: 405.36


Page no 108

Material flow sheet: PANTO PRAZOL SODIUM Qty Kgs


Output

1.6 1.3 0.45 3

5-di fluoromethoxy)1 H-benzimidazole-2-thiol 2- (Chloromethyl)-3,4dimethyl pyridine NaOH IPA

2.85 2.1 0.40

Mother liquor (IPA recovery) Waste water Drying loss

Kgs Starting Material Kgs Product Kgs W aste 1.6 1.3 0.45 3

5-di fluoromethoxy)1 H-benzimidazole-2-thiol 2- (Chloromethyl)-3,4dimethyl pyridine NaOH IPA

1.00 PANTOP RAZOL SODIUM

2.1 2.85 0.40

waste water IPA recovery Drying loss


Reaction

Purification



Page no 109

26). Product name: Montelucast Ester compound, THF treated with NAOH. The reaction is further treated with Tartaric acid & Methanol, to form Montelucast.

NCl

CH3 CH3

OH

SOH

O

NaOH

Ester compound

NCl

CH3CH3

OH

SO

O

Na

Montelucast Sodium salt

MW: 608.18


Page no 110


Page no 111

27). Product name: IO XAGLIC ACID 3-amino 5-benzoyl 2, 4, 6-triiodo benzoic acid is treated with 2- amino ethanol, in presence of Toluene. The mass is further treated with Triethyl Amine to give IOXAGLIC ACID

I I

I

NH2Cl

O

COOH

+ OH

NH2

I I

I

NH2NH

O

COOH

OH

I I

I

NNH

O

NH

CH3

O

CH3

CH3

O

Cl

O

I I

I

NH

O

COOH

OH NH

I I

I

NNH

O

NH

CH3

O

CH3

CH3

OO

Ioxaglic acid

MW: 1268.88

2-aminoethanol

3-amino-5-(chlorocarbonyl)-2,4,6-triiodobenzoic acid


Page no 112


Page no 113

28).Product Name: Cilnidipine Brief Manufacturing Process: Charge Methanol heat and ref lux distilled out IPA Add Methyl cello so lve, Cinamyl Aceto Acetate, 3 Nitro Benzaldhyde , Methanol cool & filters dry in RCVD to get Cilinidipine Cilnidipine stage-01 (CBD) reaction scheme: CBD:

CH3

O

O

CH3O

O

MW: 160.16C7H12O4

+

N+

O-

O

O

CH3

O

O

CH3O

O

N+

O- O

3-Nitrobenzaldehyde

C7H5NO3MW: 151.122-Methoxy ethyl -2- (3-Nitrobenzylidene) acetoacetate

C14H15NO6MW: 293.28

Cilnidipine Benzylidene Deriv ativ e

2-Methoxy ethy acetoacetate

CBD (stage-01)

Cilnidipine reaction scheme:

CH 3

O

O

CH 3O

O

N+

O-

O

+ O

CH 3NH 2

O

3-Amino crotonic acid cinnamyl ester (CAC)

C 13H 15NO 2MW: 217CBD

NH

C H 3CH 3

OO

OCH 3 O O

N+

O-

O

Cilnidipine

Cilnidipine C 27H 28N 2 O7 MW: 492.53

(stage-01)

Mol. wt: 293.28 C 14H 15NO 6

O

OCH 3

O

+ NH3

AmmoniaCinnamyl aetoacetate

Mol.wt: 218.25 C 13H 14O 3

O

C H 3NH 2

O

3-Amino crotonic acid cinnamyl ester (CAC)

MW: 217 C 13H 15NO 2


Page no 114

Product: C ilnidipine Stage-01 (CBD)Material Flow Sheet: Quantity Kgs


Out put

200 2-Methoxy Ethyl Acetoacetate (2-MEAA)

530

Isopropyl alcohol

17.5 Piperidine

208 3-Nitrobenzaldehyde

20 Glacial acetic acid

475 195

Recovery of Isopropyl alcohol To ETP waste

Waste water

45 Evopration loss

10 drying loss


200 2-Methoxy Ethyl Acetoacetate (2-MEAA)

195 1) To ETP waste:

530 Isopropyl alcohol 0 2) Waste Water

17.5 Piperidine

208 3-Nitrobenzaldehyde

475 3) Recovery of Isopropyl alcohol

20 Glacial acetic acid 45 4) Recovery loss 10

250 Cilnidip ine stage-01 (CBD)

5) Drying Loss 975.5 Total 250 Total 725 Total

Reactor

Filter

Drying

Receiver

Collection Pit


Page no 115

Product: C ilnidipine Final Material Flow Sheet:

Quantity Kgs


Out put

150 Cinnamyl Acetoacetate

50

Ammonium anhydrous Gas

198 CBD (Stage-01) 1363 Isopropyl Alcohol

0.370

2-Morpholinoethanesulfonic acid (Monohydrate)

3673.5 Methanol

3130 1160

Recovery of Methanol Recovery of IPA

138 Waste

746 Evopration loss of

40 drying loss


150 Cinnamyl Acetoacetate

1) To ETP waste:

50 Ammonium anhydrous Gas

198 CBD (Stage-01)

3130 1160

2) Recovery of Methanol Recovery of IPA

1363 Isopropyl Alcohol 746 3) Recovery loss

0.370

2-Morpholinoethanesulfonic acid (Monohydrate)

138 4) waste

3673.5 Methanol

220 Cilnidip ine (Final)

40 5) Drying Loss 5434.87 Total 220 Total 5214 Total

Reactor

Filter

Drying

Receiver

Collection Pit


Page no 116

29). Product name: Amlopidine Besylate:- STEP 01: Phthalicanhydride & Ethanol Aminereacted to give step-I (Hep) STEP 02:- Step-I (Hep) is treated with ethyl chloro aceto acetate to give step-II (Pheema) STEP 03:- St ep-II (Pheema) is treated with MAC to give Phthaloyl Amlodipine STEP0 4: Phthaloyal Amlodipine is reacted with NH3 to give Amlodipine Base STEP05:- Amlodipine Base is treated with to give Amlodip ine Besylate

O

O

O

+ OHNH2 N

O

O

OH

ClCH2COOCH2CH3

N

O

O

OO CH3

O

CHO

Cl ++CH3 O CH3

ONH2

N

O

O

ONH

COOCH3H5C2OOC

CH3

Cl

NH2 ONH

COOCH3H5C2OOC

CH3

Cl

2-aminoethanol2-(2-hydroxyethyl)-1H-isoindole-1,3(2H)-dione

2-chlorobenzaldehydeethyl (2Z)-3-am inobut-2-enoate

MW: 148 MW: 61MW: 191

MW: 164.5

MW: 319

MW:115 MW: 140.5

MW: 538.5

MW: 31CH3NH2

Amlodipine MW: 409

Phthalic anhydride

C6H6SO3Amlodipine Besilate

MW: 567


Page no 117

Amlodipine Bisylate Material Flow Sheet & Material Mass Balance Stage:1 HEP Qty Kgs


Output

1.0 Phthalic anhydride 0.4 Mono ethanol amine 5 O-Xylene Reactor

Extraction

4.5 Solvent Recycle &

filtration 0.0 Waste for treatment

drying 0.70 Drying loss

Kgs Starting Material Kgs

Product Kgs

W aste

1.0 Phthalic anhydride 1.2 Stage-1 4.5 Solvent Recycle &

0.4 Mono ethanol amine reuse

5.0 O-Xylene 0 Waste for treatment

0.70 Drying loss 6.4 Total 1.2 Total 5.20 Total

Stage:2 PHEEMA oil Qty Kgs


Output

1.0 stage-01 8.7 Toluene Reactor

0.86 Ethyl 4 chloro aceto acetate

0.48 Sodium hydr ide

Extraction 8.5 Solvent Recycle &

0.43 Acetic acid reuse




Kgs Product

Kgs Waste

1.0 stage-01 1.3 Stage-2 8.5 Solvent Recycle &

8.7 Toluene reuse

0.86 Ethyl 4 chloro aceto acetate 1.7

Waste for treatment

0.48 Sodium hydr ide 0.43 Acetic acid 0.0 Drying loss 11.5 Total 1.3 Total 10.2 Total


Page no 118

Stage:3 Phthaloyl amlodipine

Qty Kgs


Output

1.0 Stage-02

0.5 O-chlorobenzaldehyde Reactor

1.05 Methyl 3-aminocrotonate

4.9 Acetic acid

Extraction 7.2 Solvent Recycle &

3.5 Methanol reuse

3.7 IPA filtration 5.0 Waste for treatment

0.06 Morpholine drying

0.9 Drying loss


Kgs Product

Kgs Waste

1.0 Stage-02 0.8 Stage-3 7.2 Solvent Recycle &

0.5 O-chlorobenzaldehyde reuse

1.05 Methyl 3-aminocrotonate 5.8

Waste for treatment

4.90 Acetic acid 3.50 Methanol 0.9 Drying loss 3.70 IPA 0.06 Morpholine 14.7 Total 0.8 Total 13.9 Total


Page no 119

Stage:4 Amlodipine Base QtyKgs Input Reaction & Equipment QtyKgs Output

1.0 Stage-03 0.57 Monomethyl amine 40% Reactor

3.0 water Extraction 0.0 Solvent Recycle &

reuse


drying 0.5 Drying loss QtyKgs Starting Material Qty Kgs Product Qty Kgs Waste


0.5 Monomethyl amine 40% reuse

3.00 water 2.7 Waste for treatment

0.5 Drying loss

4.5 Total 1.3 Total 3.2 Total Stage:5 Amlodipine Bisylate

Qty Kgs Input Reaction & Equipment Qty Kgs Output 1.0 Stage-04

0.57 Benzenesulphon ic acid Reactor

14.5 IPA Extraction 14.0 Solvent Recycle &

reuse





0.57 Benzenesulphon ic acid reuse

14.50 IPA 0.5 Waste for treatment

0.7 Drying loss 16.1 Total 0.9 Total 15.2 Total


Page no 120

30) Cetrizine: Process flow diagram for Cetrizine: 1-[(4-Chlorophenyl)pheny lmethyl] Piperizine reacted with L- Tartaric acid , 2 Chloro Ethoxy Acetonitrile in presence of Sodium Carbonate & KI , to form Base. Base is reacted with Conc. HCL to form Cetrizine HCL.

O

C l

C l

Cl

N

Cl

NH

N

Cl

N

O H

N

C l

N

O O H

O

Para ChloroBenzophenoneC 13H 9 OCl MW: 216.5

(4 -Chlorophenyl) phenyl methanolC 13 H11 OCl MW: 218.5

O H

C l

1 -Chloro -4 -[Chloro (phenyl) methyl] benzeneC 13 H10 Cl 2 MW: 237

2 -[4 -((4 -Chlorophenyl (phenyl) methyl) -Piperazin -1 -yl] ethanol

C 19H 23 N 2OCl MW: 330.85

1 -[4 -Chlorophenyl (phenyl) methyl] Piperazine

C17 H 19N 2 Cl MW: 286.79

2 -[4 -((4 -Chlorophenyl) (phenyl) methyl) -Piperazin -1 -yl) ethoxy] Acetic acid

C 21H 2 5O 3N 2 Cl MW: 388.9CETIRIZINE BASE

HClCETIRIZINE

Di HYDROCHLORIDE

REACTION SCHEME FOR CETIRIZINE HYDROCHLORIDE

4 - Chlorobenzhydryl PiperazineOR

MW: 461.82C 21 H2 5O 3 N2 Cl . 2HCl

n - 1 intermediate

n - 2 intermediate

NH

NH Pipearzine


Page no 121

Product: C etirizine Stage-01 (CMP) Material Flow Sheet:

Qty.Kg Inputs Reaction & Equipment Qty. Kgs Out put 70 4CHLOROBENZOPHE

NONE

1.8 CAUSTIC SODA FLAKES

6.3 SODIUM BOROHYDRIDE

15 GL ACIAL ACET IC ACID

545 HYDROCHLORIC ACID

85 CAL CIUM CHL ORIDE

670 TOL UE NE

100 PIPERAZINE ANHYDROUS

80 CAUSTIC SODA LYE 4540 PURIFIE D W ATER

600 Recovery of toluene

5720 Waste water 88 n-HEXANE

276 Meth anol 65 Evopration

Loss

Moisture

drying lost

Kgs Starting Material Kgs Product Kgs Waste 70 4-

CHLOROBENZOPHENONE 1) To ETP waste:

1.8 CAUSTIC SODA FLAKES 5720 2) Waste Water

6.3 SODIUM BOROHYD RIDE

15 GLACIAL ACETIC ACID 600 3) Recovery of

toluene 545 HYDROCHLORIC ACID 65 4) Recovery loss 85 CALCIUM CHLORIDE 20 5) Drying Loss

670 TOLUENE 100 PIPERAZINE ANHYDROUS 80 CAUSTIC SODA LYE

4540 PURIFIED WATER 88 n-HEXANE

276 Meth anol

70 Cetirizine stage-01 (CMP)

6477.1 70 Total 6405 Total

Reactor

Filter

Drying

Receiver

Collection Pit


Page no 122

Product: C etirizine Stage-02 (Cetirizine HCl) Material Flow Sheet: Qty Kgs Inputs Reaction & Equipment Qty.Kgs Out put

70

1-[(4-chlorophenyl (phenyl) methyl] pi perazine

48.5 Triethyla mine (TE A)

30.5 2- Chloroetha nol

200 Dimethyl For mamide (DMF)

40 Potassi um Hydroxide Flakes (KOH)

42.6 Sodi um Monochloro Aceta te

50 Hydrochloric Acid (CP Grade)

612 Methyl ene Di chloride (MDC)

822 Acetone

560 430

Recovery of toluene Recovery of MDC

3070 Waste water 631 Toluene

1830 Water

240 15

Evopration loss Drying loss

Kgs Starting Material Kgs Product Kgs Waste 70

1-[(4-chlorophenyl (phenyl) methyl] piperazine

1) To ETP waste:

48.5 Triethyla mine (TE A) 3070 2) Waste Water 30.5 2- Chloroetha nol 990 3) Recovery 200 Dimethyl For mamide

(DMF) 240 4) Recovery loss

40 Potassi um Hydroxide Flakes (KOH)

42.6 Sodi um Monochloro Aceta te

15 5) Drying Loss


612 Methyl ene Di chloride (MDC)

822 Acetone 631 Toluene

1830 Water

60 Cetirizine stage-02 (Cetirizine HCl)

4376.6 60 Total 4315 Total

Reactor

Filter

Drying

Receiver

Collection Pit


Page no 123

31). Product name: C arvidilol 2-(ethoxy phenoxy) ethylamine & 4-(2, 3 epoxy propoxy) carbezo le treated with mix of water & ethyl acetate, filtered & dr ied to give Carv idilol.

NH

O

O

+

ONH2

OCH3

2-(ethoxyphenoxy)ethylamine compound4-(2,3 epoxypropoxy)carbezole

NH

O

OH ONH

OCH3

CarvedilolMW: 406.47


Page no 124

32).Product name: ZO LPIDEM 3-bromo-N, N-dimethyl-4-oxo-4-p-tolyl-butyramide, MIBK are treated with 2-amino-5-methylpyridine. The reac mass treated with Sodium Carbonate. The stage -1 materail obtained is treated with Tartaric acid & crystallized from Acetone to give Zolpidem

NCH3

NH2

+CH3

Br

O N

NCH3

CH3

H

NCH3CH3

OO

NCH3CH3

O

N

NCH3

CH3

OH

NCH3CH3

O

N

NCH3

CH3

Cl

SOCl2

NCH3CH3

O

N

NCH3

CH3

Reduction

5-methylpyridin-2-amine2-bromo-1-(4-methylpheny l)ethanone

N,N-dimethyl-2-oxoacetamide

ZolpidomMW: 307.39


Page no 125


Page no 126

33).Product name: PROMEDOL HCl Trimeperidine is treated with HCL & crystallized from Acetone, filtered & dried to give Poamedol HCl

+HCl

Qty Kgs


Output

1.0 TRIMEPERIDINE

0.4 HCl 5 ACETONE 4.6 Acetone Rec 0.6 Waste water 0.2 Drying loss

Kgs Starting material

Kgs Product

Kgs Waste

1.0 TRIMEPERIDINE 1 TRIMEPERIDINE. HCl 4.6 Acetone Rec

0.4 HCl 0.6 Waste water 5 ACETONE 0.2 Drying loss


Wet Solid

Wet Solid


Page no 127

34).Product name: Indolinone. 2, 6 DCP, sodium Methoxide, Ethyl Chloro Acetate, An iline Caustic Are added to reactor in required proportion. The mass is allowed to react together at required temperature and pressure condition, once the reaction is over, the material is f iltered and dried in dreir and packed in drums and stored as DCDPA DCDPA, Toluene, Chloro Acetyl chloride are added to a reaction vessel, Hydrogen Chlor ide gas generated during the reaction is scrubbed off with the help of caustic solution in scrubber tower. The material filtered, washed and dried packed and store as CPDCA CPDCA, Aluminium Chloride to allow react in a reactor and controlled temperature condition. The mass is then quenched in water and filtered, Hydrogen chlor ide gas generated during reaction and quenching is taken to scrubber system. Neutralized material is f iltered, washed, dried, Packed and store as Indolinone

OH

Cl

Cl

+ ClCH2COOC2H5

NH2

NH

Cl

Cl

2, 6-Dichloro phenol

Ethy l chloroacetate

2, 6-Dichlorodipheny l amine (DCDPA)MW: 163

MW: 122.5

MW: 238

Aniline

N

ClO

ClCH2COCl

Chloroacety l chloride

CPDCA

MW: 314.5

AlCl3N

O

Indolinone

MW: 278.1

Cl

Cl

Cl

Cl


Page no 128

Material flow sheet: Step – 1 Qty Kgs


Output

0.772 1.82 0.544 0.424 0.275 2.41

2,6 D.C.P Sodium Methoxide Soln. 25% Ethyl Chloro Acetate Aniline Caustic Lye Water

2.3 0.24 0.01 2.295 0.4


Kgs W aste Kgs W aste Kgs Waste 0.772 1.82 0.544 0.424 0.275 2.41


1.00

D.C.D.P.A 2.295 0.01 0.24 2.3 0.4

1) To ETP waste Waste water DCP recovery Sodium Chloride 2) To recovery 3) Moisture loss


Receiver

Reactor – 101

Filter

Collection pit

Moisture removal


Page no 129

Product: INDO LINO NE Step-II Material flow sheet

Qty Kgs


Output

0.8 0.58 2.22

D.C.D.P.A Chloro Acetyl Chlor ide

Ethoxy ethanol

0.15 2.37 0.08

HCl gas to Scrubber Ethoxy ethanol recovery Drying loss

Kgs W aste Kgs Waste Kgs Waste 0.8 0.58 2.2

DCDP A Chloro Acetyl Chlor ide Ethoxy Ethanol

1

C.P.D.C.A 0.15 2. 37 0.08

1) HCl gas 2) To recovery 3) Drying loss


Reactor – 201

Filter

Collection Tank

Drying


Page no 130

Product: INDOLINONE Material flow sheet

Qty Kgs


Output

1.12 0.656 3.7

C.P.D.C.A Aluminium Chlor ide

Water

0.149 3.977 0.35


Kgs W aste Kgs W aste Kgs Waste 1.12 0.656 3.7

C.P.D.C.A Aluminium Chlor ide Water

1.00

Indolinone 3.977 0.149 0.35



Reactor – 301

Filter

Collection pit

Moisture removal

Quencher


Page no 131

35).Product name: ATENALOL BRIEF MANUFACTURING P ROCESS:- In the first stage, Para-Hydroxy Phenyl acetamide condensed with Epichlorohydrine in presence of Base to give epox ide compound. This is condensed in second stage with Isopropylamine to give Atenolo l crude compound. Atenolol crude converts in to Atenolol pure by purification.

OHO

NH2PHPA

+ NaOH +O

Cl

EPICHLOROHYDRINE

OO

NH2

O

EPOXIDE COMPOUND

OO

NH2

OH

NH CH3

CH3

ATENOLOL

MONO ISOPROPYL AMINE

(H3C)2CH-NH2HCl/NaOH

2-(4-hydroxyphenyl)acetamide

2-{4-[2-hydroxy-3-(isopropylamino)propoxy]phenyl}acetamide


Page no 132

Product: Atenolol Stage-01 (Crude) Material Flow Sheet:

Quantity Kgs


Out put

100 Para Hydroxy phenyl acetamide (PHPA)

57.5 Caustic Flakes

123 Epichlorohydrin

552 Mono isopropyl amine

50 Conc. HCl 2637.5 Water

420 Recovery of Mono isopropyl amine

Waste water

80 Evopration loss of Mono isopropyl amine



100 Para Hydroxy phenyl acetamide (PHPA)

1) To ETP waste:

57.5 Caustic Flakes 2850 2) Waste Water

123 Epichlorohydrin

552 Mono isopropyl amine

420 3) Recovery of Mono isopropyl amine

50 Conc. HCl 80 4) Recovery loss 2637.5 water

130 Atenolol stage-01 (Crude)

40 5) Drying Loss


Reactor

Filter

Drying

Receiver

Collection Pit


Page no 133

Product: Atenolol Stage-02 (Pure) Material Flow Sheet:

Quantity Kgs


Out put

130 Atenolol Crude stage-01

1027 Acetone

39 Acetic acid 32.5 Caustic flakes

942.5 Water

820 Recovery of Acetone

Waste water

200 Evopration loss of Acetone



130 Atenolol Crude stage-01

1) To ETP waste:

1027 Acetone 1020 2) Waste Water

39 Acetic acid 32.5 Caustic flakes

820 3) Recovery of Acetone

942.5 Water 200 4) Recovery loss

100 Atenolol stage-01 (Crude)

30 5) Drying Loss


Reactor

Filter

Drying

Receiver

Collection Pit


Page no 134

36).Product name: 2 Methyl Imidazole Acetaldehyde is reacted with Glyoxal & than treated with Liq NH3. The mass is concentrated, treated with Toluene, filtered through filtered & dried to get 2-MI

CH3 O

H

+H

H

O

O

+ NH3

NH N

CH3

2-methyl-1H-imidazole

acetaldehyde Glyoxal

Toluene

MW: 82.1


Page no 135

Qty Kgs


Output

2.1 2.2 2.3 7

Glyoxal Ammonia Acetaldehyde Butanol

6.7 5.6 0.30

Butanol recovery Waste water Drying loss

Kgs Waste Kgs Waste Kgs W aste 2.1 2.2 2.3 7

Glyoxal Ammonia Acetaldehyde Butanol

1.00

Atenalol 6.7 5.6 0.3

Reco. Butanol Waste water Moisture loss


Reactor

Filter

Collection pit

Moisture removal

Concentration


Page no 136

37). Name of product: Manu process for Maglumine: IPA is charged, add N –Octyl-D- Glucamine under stirring, slowly heat to 60-70 degree centigrade. Maintain for 5 hours. Cool the mass to room temp. Filter & dry the mass to give Maglumine.

+

Methylamine

OHOH

OH

OH

OH

OH

Sorbitol

(2R,3R,4R,5S)-hexane-1,2,3,4,5,6-hexol

OHNH

CH3

OH

OH

OH

OH- H2O

Meglumine (N - Methyl Glucamine)

+ IPA Purification

OHNH

CH3

OH

OH

OH

OH

Meglumine (N - Methyl Glucamine)

C6H14O6 MOL. WT: 182.17

CH3 NH2

CH5N MOL. WT: 31.06

C7H17NO5 MOL. WT: 195.21

C7H17NO5 MOL. WT: 195.21

Qty Kgs


Output

1.0 Sorbitol

0.75 Methyl amine

3 IPA 3.75 Filtrate ML IPA recovery 0.85 Meglumine 0.15 Drying loss


1.0 Sorbitol 0.85 Meglumine 3.75 1) Filtrate for IPA recovery

0.75 Methylamine 3.0 IPA 0.15 2) Drying loss


Filteration FiltrationFiltr

Wet Solid

Moist ure


Page no 137

38).Nam e of product : Lucanthone Hydrochloride Stage-1 Reaction of Dithiosalicylic acid and 4-Chlorotoluene with sulfuric acid gives Intermediate Luca-I. Stage-II Lucanthone-I is reacted with N,N Diethyl ethylene Diamine & pyridine to give Lucanthone-II Stage-III Lucanthone –III is reacted with HCL to give Lucanthone Hydrochlor ide

LUCANTHONE HYDROCHLORIDE REACTION SCHEME

Stage-1 Luca IO

OH

S

O OH

S

Dithiosalicylic acid

+

Cl

CH3

H2SO4

Cl

CH3

C=O

S

1-Chloro-4-Methylthiaxanthone

Luca I

Stage-2 Luca II

Cl

CH3

C=O

S

1-Chloro-4-Methylthiaxanthone

Luca I

H2N-CH2-CH2-NCH2-CH3

CH2-CH3

+

N,N' Diethyl ethylene diamine

Pyridine

S

C=O

CH3

HN-CH2-CH2-NC2H5

C2H5

1-(2-diethylaminoethylamino)-4-methylthiaxanthone

Luca II

Stage-3 Lucanthone HCL

S

C=O

CH3

HN-CH2-CH2-NC2H5

C2H5

1-(2-diethylaminoethylamino)-4-methylthiaxanthone

Luca II

HCL

IPAS

C=O HN-CH2-CH2-N

CH3

C2H5

C2H5

. HCl

1-(2-diethylaminoethylamino)-4-methylthiaxanthone Hydrochloride

Lucanthone Hydrochloride


Page no 138

Product: Lucanthone Material Flow Sheet:

Qty Kgs


Output

45 Thio Salicyclic acid/Di thio Salicylic Acid

100 To recovery 60 Sodium Carbonate

50 4-Chlorotoluene 100 Hydrochlor ic Acid

300 Ethanol 56 Pyridine

110 Waste Water


Kgs Starting Material Kgs Product Kgs W aste 45 Thio Salicyclic acid/Di

thio Salicylic Acid 60 Sodium Carbonate 50 4-Chlorotoluene

100 Hydrochlor ic Acid 300 Ethanol

56 Pyridine

70 Lucanthone

110 300 100 31

To ETP Waste Waste Water Sodium Acetate Sodium Chlor ide 2) To Recovery 3) Moisture Loss

611 Total 70.00 Total 541 Total

Reciever

Reactor

Filter

Moisture removel

Collection Pit


Page no 139

39). Name of product: Process of synthesis for METRONIDAZO LE: 2- Methyl 5 –Nitro Imidazole is reacted with Ethylene Oxide. The reacted mass is quenched in water, p H adjusted. Mixt ure of METRONIDAZOLE & 2 MNI is separated to yield Crude. Crude Metronidazole is crystallized, filtered, dried to give Metronidazole. Reaction scheme:

NH

N

CH3O2N

+ O N

N

CH3O2N

OH

H2SO4

Water

2-methyl-5-ni tro-1H-im idazole Ethy lene Oxide MetronidazoleMW: 171.15MW: 127.10

Synthesis of Metronidazole Benzoate: Metronidazo le is reacted with Benzoyl Chlor ide for 24 hours. Once reaction is over, solvent is distilled out. Methanol is added , chilled , filtered , dried to give Metronidazo le Benzoate. Reaction Scheme:

N

N

CH3O2N

OH

Metronidazole

MW: 171.15

+

ClO OO

N

NO2N

CH3

Benzoy l chloride Metronidazole Benzoate

MW: 275.3MW: 140.56

Methanol


Page no 140

Name of product: Metronidazole Material Balance Qty Kgs


Output

1.0 2methyl-5Nitroimdazole 0.96 Acetic acid 0.06 Acetic anhydride 1.30 Ethylene oxide

0.38 Caustic Lye 1.33 Liq. Ammonia 5.64 Was. Water for

Treatment

1.24 Sulfuric acid 0.005 Water use for MNI 0.00083 Charcoal Recovery

0.005 Purified water 0.00083 Waste solid Kgs Starting Material Kgs Product Kgs Waste

1.0 2-methyl 5-Nitro imidazo le 0.63 Mertonidazo le 5.64 Waste water for 0.96 Acetic acid Treatment 0.06 Acetic anhydride

1.30 Ethylene oxide 0.005 Water use for MNI recovery

0.38 Caustic Lye 1.33 Liq. Ammonia 1.24 Sulfuric acid 0.00083 Waste solid

0.00083 Charcoal 0.005 Purified water


Filteration

Reactor

Wet Solid

Filteration


Page no 141

40).Nam e of product: Diatrizoic Acid (2, 4, 6-Triiodo-3, 5-diacetylaminobenzoic acid): Acetylation of 2, 4, 6 Triiodo-3, 5-diaminobenzoic acid by Acetic anhydride with sulfur ic acid to give Diatrizo ic acid derivative.

COOH

I

NH2

I

I

H2N

(CH3CO)2O

H2SO4

H2O

COOH

I

I

I

NHCOCH3H3COCHN

2,4,6 Triiodo 3,5 Diaminobenzoic acid 2,4,6 Triiodo3,5 diacetylaminobenzoic acid

Name of product: Diatrizoic Acid Material balance Qty Kgs


Output

1.0 2,4,6 triiodo-3,5 diaminobenzoic acid

3.0 Acetic Anhydride

0.5 Sulfuric Acid

1.41 Purified Water

4.9 Waste water for treatment

0.15 Drying loss


1.0 2,4,6 triiodo-3,5 diaminobenzoic acid 0.86 Diatrizoic acid 4.9

1) Waste water for treatment

3.0 Acetic Anhydride 0.5 Sulfuric Acid 0.15 2) Drying loss

1.41 Purified Water 5.91 Total 0.86 Total 5.05 Total

Filteration

Reactor

Wet Solid

Moist ure


Page no 142

41). Name of product: Econazole Brief m anufacturing process: Reaction of 1-(2, 4-dichlorophenyl)-2-imidazole-1y l- Ethanol with sodium hydride base in tetrahydrne to give its sodium salt followed by treatment of resulting sodium salt with p-chlorobenzyl chloride in dimethylformamide solvent at reflux temp to give Econazo le.

Econazole Reaction Scheme

ClCl

OH

N N

1-(2,4 dichlorophenyl)-2-imidazole-1-yl-ethanol

NaHSodium Hydride

THF

Cl

ONa

N N

Cl

1-(2,4 dichlorophenyl)-2-imidazole-1-yl-sodiumethoxide

Cl

ONa

N N

Cl

1-(2,4 dichlorophenyl)-2-imidazole-1-yl-sodiumethoxide

+Cl

Cl

DMF

Cl

O

N N

Cl

Cl

1-[2-[(4-chlorophenyl)methoxy]-2-(2,4-dichlorophenyl)ethyl]imidazole

Econazole

4-chlorobenzyl chloride


Page no 143

Nam e of product: Econazole Material balance Qty Kgs


Output

1.0 1-(2,4 dichloropheny l)-2-

imidazole-1-y l-ethanol

0.22 Sodium Hydride

5.0 Tetrahydrofuran

11.2 Recovery & reuse

0.6 4-Chlrobenzyl chloride

0.22 Drying loss

6 Dimethylformamide


1.0

1-(2,4 dichloropheny l)-2-imidazole-1yl ethanol 1.40 Econazo le 11.20

Recovery & reuse

0.22 Sodium Hydride

5.0 Tetrahydrofuran 0.22 Drying loss

0.6 4-Chlrobenzyl chloride

6 Dimethylformamide 12.84 Total 1.40 Total 11.42 Total

Filteration

Reactor

Wet Solid

Moist ure


Page no 144

42).Nam e of product: Meclizine CAS No. [596-65-3]Brief Manufacturing Process: Stage-1: Condensation of 1-(ch loromethyl)-3-methylbenzene with piperazine and HCl gas to produce 1-[(3-methylphenyl) methyl] piperazine dihydrochloride(stage-1) Stage –II: Stage –I is reacted with 4 Chloro Benaz Hydryal Chloride to give step-II Meclizine crude Stage-III : Meclizine crude is pur ified to give Meclizine

Stage-1:

Cl + NH NHN NH

3-Methyl benzyl ch loride Piieraz ine 1-[(3-methylphenyl)methyl]p iperazine dihydrochloride

.2HCl

Stage-2

1-[(3-methylphenyl)methyl]piperazine dihy drochloride

+

4-chlrobenzhydryl chloride

Cl

Cl

N NH .2HCl

N

N

CH3

Cl

1-[(4-chlorophenyl)phenylmethyl] -4-[(3-methylphenyl)methyl]piperazine

Meclizine


Page no 145

Name of product: Meclizine Material balance Stage:1 1-[(3-methylphenyl)methyl]piperazine dihydrochloride Qty Kgs Input Reaction & Equipm ent Qty Kgs Output

1.0 1-(chloro methyl)-3 methyl benzen e

1.6 Piperazine

3.0 Methanol

3.0 Solvent Recycle

2.5 HCl(gas)

3.95 Waste for treatment

0.10 Drying loss


1.0 1-(chloro methyl)- 3 methyl benzene 1.05

Stage-1 3.0

Solvent Recycle reuse

1.6 Piperazine 3.95 Waste for treat 3.0 Methanol 2.5 HCl (gas) 0.10 Drying loss 8.1 Total 1.05 Total 7.05 Total

Meclizine Stage-II Material balance Qty Kgs Input Reaction & Equipment QtyKgs Output

1.0 1-[(3-methylphenyl)-methyl piperazine dihydrochloride

1.25 (4chlorophenyl)phenylmethyl Chlor ide

0.05 Potassium Carbonate

3.0

Toluene

3.0

Solvent Recycle & reuse

0.7

Waste water treat

0.15 Drying loss

Kgs Starting Material Kgs Product Kgs W aste 1.0 1-[(3-methylphenyl)-methyl 1.45 Meclizine 3.0 piperazine dihydrochloride

Solvent Recycle

1.25 (4chlorophenyl)phenylmethyl

Chlor ide 0.7 Waste for treatment

0.05 Potassium Carbonate 3.0 Toluene 0.15 Dry loss


Filteration

Reactor

Wet Solid

Moist ure

Reactor

GENERAL


Page no 146

43).Nam e of product: Chlorhexidine Digluconate: Process: Reaction of Hexamethylene bis-dicyandiamide with P-chloroan iline HCL with Ethoxy ethanol 130-140 for 2 hours to get Chlorhexidine Base. By addition of D-Glucon ic acid to produce Chlorhexidine Digluconate.

NC NH C NH (CH 2)6 NH C N H C N

N HN H

+ .H Cl

C l

N H2

H ex am ethylene 1 ,6 Dic y and i amide

2

P -C hloroan iline Hy droch loride

E thox y ethano l

A cet ic ac id

D-G l ucon ic A c id

130-140 0C

H N C NH C N H (C H2)6 N H C NH C N H

NHNH

ClC l

NH N H

HO

O H

O H

O H

O H O

O H

H O

O H

O H

O H

O H O

O H

C hl orhexid i ne D ig luconate

D-G luc on ic ac id c om pound with N,N'' b is (4-ch loropheny l)-3 ,12-d i imi no-2 ,4 ,11,13-

te t raazate tradec ane d ii midam ide (2 :1)


Page no 147

(VII) Nam e of product: Chlorohexidine Gluconate Qty Kgs


Output

1.0 Hexamethylene bis-di cynamide

1.3 P-chloroaniline hydroch loride

7.1 Ethoxyethanol

7.1 Solvent Recovery

1.0 Acetic acid

2.0 Purified water

6.2 Waste water for

2.0 D-glucon ic acid 0.1 Drying loss



1.0 Hexamethylene bis dicyandiamide 1.0

Chlorhexidine Glucon 7.1

Solvent Recovery

1.3 P-chloroaniline hydroch loride 6.2

Waste water for

7.1 Ethoxyethanol treatment 1.0 Acetic acid 0.1 Drying loss 2.0 Purified water 2.0 D-glucon ic acid


Reactor

Wet Solid

Add of D-

Moist ure


Page no 148

44) Product Name: Indinavir Charge 3 Methyl pyridine, Piperazine, Ethyl Acetate, Caustic Flakes, D M Water IPA ethyl Acetate heat and ref lux distilled out IPA. Cool & filters dry in RCVD to get

OH

NH Cl

O

OH+

NH

NH

NHO

CH3

CH3CH3

+NCl

2-benzyl-5-chloro-4-hydroxy-N-(2-hydroxy-2,3-dihydro-1H-inden-1-yl)pentanamide

N-tert-butylpiperaz ine-2-carboxamide

3-(chloromethyl)pyridine

MF: C21H24O3NClMF: C 9H19ON3

MF: C 6H6NCl

MW: 185 MW: 127.5

NaOH

OH

NH N

O

OH N

NHCH3

CH3CH3

O

N

MF: C36H47N5O4

INDINAVIR

MW: 613.79

C21H24O3NCl C9H19ON3 C6H6NCl+ +2 NaOH

C36H47N5O4 2NaCl+MW: 373.5 MW: 185 MW: 127.5 MW: 613.79

2 H 2O+MW: 117 MW: 36

MW: 80

Stoichiometry:


Page no 149

Indinavir

Qty Kgs


Output

100 3 Methyl Pyridine

60 Piperazin (Veleramide Comp)

40 Ethyl Acetate 700 Caustic Flakes

1000 D M Water 400 IPA 300 Ethyl Acetate

1000 1230 300

To recover Waste water Moisture Loss

Kgs Starting Material Kgs Product Kgs Waste 100 3 Methyl Pyridine

60 Piperazin (Veleramide Comp)

40 Ethyl Acetate 700 Caustic Flakes

1000 DM Water 400 IPA 300 Ethyl Acetate

70 Indinavir 1230.00 1000.00 300.00

1) To ETP waste: Waste Water Sodium Acetate Sodium Chloride 2) To Recovery 3) Moisture Loss


Reciever

Filter

Reactor

Moisture removel

Collection Pit


Page no 150

45).Nam e of product: Ne virapine Charge Dipyrido Diazepine, Ecyclopropyl chloride Caustic Flakes Toluene in reactor and add DM water IPA Ethyl acetate, IPA+HCl heat and reflux distilled out IPA Add DM water cool & filters dry in RCVD to get Nev irapine

2 NaOHN

CH3

NH

N

O

N

Nev irapineMF: C12H11N4OCl

MW: 263.3MF: C15H14N4O

MW: 266.8

N

CH3

NH

Cl NNH2

O

Cl

2-amino-N-(2-chloro-4-methylpyridin-3-yl)pyridine-3-carboxamide

MF: C3H5ClMW: 76.5

C12H11N4OCl C3H5Cl C15H14N4O+ + 2 NaCl

MW: 263.3 MW: 76.5 MW: 266.8MW: 117

Stoichiometry:

MW: 80

+ 2 H2O

MW: 36

2 NaOH

MW: 80


Page no 151

Qty Kgs


Output

100 60 40 700 1000

Dipyrido Diazep ine Eyclopropyl chloride Caustic Flakes Toluene Water

565 kg 1100 35

To recovery Waste water Moisture drying lost

Kgs Starting Material Kgs Product Kgs W aste 100 60 40 700 1000

Dipyrido Diazep ine Eyclopropyl chloride Caustic Flakes Toluene water

70 Kg Nevirapine 1100 40 90 565 35

To ETP waste: Waste Water Sodium Acetate Sodium Chlor ide 2) To Recovery 3) Moisture Loss


Reciever

Reactor

Filter

Moisture removel

Collection Pit


Page no 152

46). Product Name: Rizatriptan Charge Triazole Compound, Dimethyl amino Indo le, Catalyst, Acetonitrile, Methanol, Water heat and reflux distilled out Methanolcool & filters dry in RCVD to get Rizatriptan

NHN

N

+ Cl

NH

N

CH3

CH3

1H-1,2,4-triazole Dimethy l amino indole

MW: 69 MW: 236.50

KOH

NH

N

CH3

CH3

NN

N

Rizatriptan

MW: 269.14


Page no 153

Qty Kgs


Output

50 Triazole Compound

490 To recovery 80 Dimethyl amino

Indole 5 Catalyst

200 Acetinitrile 250 Methanol 500 Water

530 Waste water


Kgs Starting Material Kgs Product Kgs Waste 50 Triazole Compound 1) To ETP waste:

80 Dimethyl amino Indole

530 Waste Water

5 Catalyst 200 Acetinitrile

Sodium Acetate

250 Methanol Sodium Chloride 500 Water 490 2) To Recovery

40 Kg Rizatriptan

25 3) Moisture Loss


Reciever

Reactor

Filter

Moisture removal

Collection Pit


Page no 154

47). Product Name: Gabapentine Charge 1, 2 Cyclohexaneutic Acid, Urea Toluene NaOH solution, water heat and reflux distilled out Toluene Add DM D M Water, Methanol and Con HCl cool & filters dry in RCVD to get Gabapentine

OH OHO O

+ NH2 C NH2

ONH2

OH O

MF: C9H17NO2

MW: 171.23

Xabapentene2,2'-cyclohexane-1,1-diyldiacetic acid Urea

MF: C10H16O4MW: 200

MF: CH4ON2

MW: 60


Page no 155

Material Flow Sheet:

Qty Kgs


Output

100 1,2 Cyclohexaneautic Acid

1300 To recovery 60 Urea

500 Toluene 25+100 NaOH Sol + Water

300 D M Water

400 Methanol 480 Waste water 35 Conc HCl

400 IPA


Kgs Starting Material Kgs Product Kgs Waste 1) To ETP waste: 100

1,2 Cyclohexaneautic Acid 480 Waste Water

60 Urea Sodium Acetate

500 25+100

Toluene NaOH Sol + Water

300 D M Water 400 Methanol

35 Conc HCl 400 IPA

40 Kg Gabapentin

40 40 1300 20 Sodium Chloride

2) To Recovery 3) Moisture Loss


Reciever

Reactor

Filter

Moisture removel

Collection Pit


Page no 156

48). Product Name: Telmisartan Charge Benzaimidazole compound, N-methyl-O-phenylene diamine, toluene, Poly phosphoric Acid heat and reflux distilled out Toluene.Add Toluene and Bromoester cool & filters dry in RCVD to get Tewlmisartan

N

NH

CH3

CH3

OH

O

+NH

NH2

CH3

N

NH

CH3

CH3

O

N

N

CH3

Br

O

CH3

CH3

CH3

O

O

CH3 CH3

CH3O

N

N

CH3

CH3

O

N

N

CH3

Benzimidazole compound N-methylbenzene-1,2-diamine

Bromoester compound

H3PO4

Toluene

Temisartan

MW: 232 MW: 110

MW: 290

MW: 514.61


Page no 157

Qty Kgs


Output

100 Benzaimidazole compound

490 To recovery 85 N Methyl-O-

Phenylene diamine 300 Toluene 250 Poly Phosphoric Acid

300 Toluene

60 Bromoester


Kgs Starting Material Kgs Product Kgs Waste 100 Benzaimidazole

compound

85 N Methyl-O-Phenylene diamine

300 Toluene 250 Poly Phosphoric Acid

300 Toluene 60 Bromoester

70 Kg Telmisartan 500 490 35

To ETP Waste Waste Water 2) To Recovery 3) Moisture Loss


Reciever

Reactor

Filter

Moisture removel

Collection Pit


Page no 158

49). Product Name: Ondansetron Charge 1,2,3,9 Tetrahydro 9 methyl-4H-carbozole-4-One,N-(3-Chloro methyl)-2-Methyl-Indiazole, toluene, Phosphoric Acid PTS heat and ref lux distilled out Toluene Add DM water, IPA, Conc Hcl cool & filters dry in RCVD to get Ondansetron

N

N

CH3

Cl1-(chloromethyl)-2-methyl -1H-imidazole

+N

CH3

O

9-methyl-1,2,3,9-tetrahydro-4H-carbazol-4-one

N

CH3

ONN

CH3

Ondansetron

HCl

MF: C13H13NOMF: C5H7N2ClMW: 130.5 MW: 199.3

MF: C18H19N3O. HClMW: 329.83

H3PO4

C5H7N2Cl + C13H13NO C18H19N3O. HCl

Stochiometry:

MW: 130.5 MW: 199.3 MW: 329.83

Ondansetron


Page no 159

Qty Kgs


Output

100 1,2,3,9 Tetrahydro 9 methyl-4H-Carbozole-4-one

470 To recovery 75 N-(3 Chloro methyl)-2-methyl-Indiazo le

500 Toluene 100 Phosphoric Acid

700 D M Water 300 I P A

40 Con HCl 830 Waste water



100 1,2,3,9 Tetra hydro 9 methyl-4H-Carbozole-4-one

75 N-(3 Chloro methyl)-2-methyl-Indiazo le

500 Toluene 100 Phosphoric Acid 700 D M Water 300 I P A

40 Con HCl

75 Kg Ondansetron 1230 470 40



Reciever

Reactor

Filter

Moisture removel

Collection Pit


Page no 160

50) Product Name: C andesartan Charge Ethoxy benzimidazole compound, Biphenyl Tetrazole, toluene, KOH Flakes heat and reflux distilled out Toluene Add DM water, Ethyl acetate, Methanol, cool & filters dry in RCVD to get Candesartan

NHN

O

CH3

OH

O

+

NNH

N

NCl

1-(2-ethoxy-1H-benzimidazol-7-yl)ethanone 5-(biphenyl-2-yl)-2H-tetrazoleMF: C10H10N2O3 MF: C14H11N4Cl

MW: 206 MW: 270.5

NN

O

CH3

OH

O NNH

N

N

CandesartanMF: C24H20N6O3

MW: 440.45

MF: C10H10N2O3

MW: 206+ MF: C14H11N4Cl

MW: 270.5

MF: C24H20N6O3

MW: 440.45+ KCl

MW: 74.5

Stoichiometry:

KOHMW: 56

+ H2O

MW: 18

KOHMW: 56


Page no 161

Qty Kgs


Output

100 Ethoxy benzimidazo le comp

885 To recovery 80 Biphenyl Tetrazole

500 Toluene 35 KOH Flakes

600 D M Water

500 Ethyl Acetate 860 Waste water 400 Methanol


Kgs Starting Material Kgs Product Kgs W aste 100 Ethoxy

benzimidazo le comp 80 Biphenyl Tetrazole

500 Toluene 35 KOH Flakes

700 D M Water 300 I P A

40 Con HCl

70 Kg Candesartan 505 115 150 885 30



Reciever

Reactor

Filter

Moisture removel

Collection Pit


Page no 162

51). Product Name: Glipizide Charge 5-methyl pyrazine-carboxamide, Sulfenyl Compound, Toluene, NaOH flakes, PTS heat and ref lux distilled out Toluene Add DM water, IPA, Ethyl acetate, Methanol, Toluene, Amino Cyclohexane cool & filters dry in RCVD to get Glipizide

N

N

H3C

NH-CH2-CH2 SO2NH2CO + Cl3-CO-HN

DMSO

SMO

Acetic Acid

N

N NH-CH2 -CH2 SO2NHCO

H3C

CO-HN

Glipizide


Page no 163

Qty Kgs


Output

100 5-Methyl pyrazine-carboxamide

1330 To recovery 80 Sulfenyl Compound

600 Toluene 30 NaOH Flakes 15 PTS

700 D M Water

500 Ethyl Acetate 1030 Waste water 250 Methanol 400 Toluene

70 Amino Cyclohexane


Kgs Starting Material Kgs Product Kgs W aste 100 5-Methyl pyrazine-

carboxamide 80 Sulfenyl Compound


700 D M Water 500 Ethyl Acetate 250 Methanol 400 Toluene

70 Amino Cyclohexane

70 Kg Glipizide 1030 130 150 1330 35



Reciever

Reactor

Filter

Moisture removel

Collection Pit


Page no 164

52). Product Name: Glim epiride Charge Oxo pyroline compound, Methyl cyclohexyl sulfony l compound, Toluene, NaOH f lakes, PTS heat and ref lux distilled out Toluene Add DM water IPA Ethyl acetate, IPA+HCl cool & filters dry in RCVD to get Glimepir ide

+ CH3 NH NHS

Cl

OOO

MF:C16H20 N2O2MW: 272

Oxo pyrroline compound

N NHCH3

CH3

O O

MF:C8H15 N2O3SCl

MW: 254.5

Methyl cyclohexyl sulfonyl compound

MF:C24 H34N4O5S

MW: 490.61

N NHCH3

CH3

O O

SNH NH

OO O

CH3

Glimepiride

MF:C16 H20N2O2 MF:C8H15N2O3SCl MF:C24 H34N4O5S+ + NaCl

MW: 272.21 MW: 254.9 MW: 490.61 MW: 58.5

Stoichiometry:

NaOH

MW: 40

+ H2O

MW: 18

NaOH

MW: 40


Page no 165

Qty Kgs


Output

100 Oxo pyroline compound

715 To recovery 55 Methyl cyclohexyl

sulfonyl compound 600 Toluene

25 NaOH Flakes 15 PTS

500 D M Water

400 Ethyl Acetate 1030 Waste water 350 Methanol


Kgs Starting Material Kgs Product Kgs W aste 100 Oxo pyroline

compound

55 Methyl cyclohexyl sulfonyl compound


500 D M Water 400 Ethyl Acetate 350 Methanol

70 Kg Glimepiride 1030 200 715 30


2045.00 Total 70.00 Total 1975 Total

Reciever

Collection Pit

Reactor

Filter

Moisture removel


Page no 166

53). Product Name: Moxifioxacin Charge 1 cyclopropyl-6-fluro-4-oxo-chloro-quino line carboxyliacid Octohydro pyrolo, Octohydro pyrolo pyridine compound, Toluene and NaOH flakes in reactor heat and reflux distilled out IPA. Add DM water IPA Ethyl acetate, IPA+HCl cool & filters dry in RCVD to get Moxifioxacin

NHNH

H

H

+

octahydro-1H-pyrrolo[3,4-b]pyridine

N

OH

OO

OCH3

F

Cl

7-chloro-1-cyclopropyl-6-fluoro-8-methoxy-4-oxo-1,4-dihydroquinoline-3-carboxylic acid

MF: C7H14N2MW: 126.43

MF: C14H11NO4F ClMW: 311.5

N

OH

OO

OCH3

F

N

NH

H

H

MF: C21H24N3O4F

MW: 401.43

Moxifioxine

MF: C7H14N2 MF: C14H11NO4F Cl MF: C21H24N3O4F

MW: 126.43 MW: 311.5 MW: 401.43 MW: 58.5

+ + NaCl

Stoichiometry:

NaOHMW: 40

+ H2O

MW:18

NaOHMW: 40


Page no 167

Qty Kgs


Output

100 1cyclopropyl-6-fluro-4-oxo-chloro-quinoline carboxyliacid

1260 To recovery 80 Octohydro pyro lo pyridine compound

750 Toluene 32 NaOH Flakes

800 D M Water

500 I PA 1100 Waste water 450 Ethyl Acetate

40 IPA + HCl


Kgs Starting Material Kgs Product Kgs W aste

100 1cyclopropyl-6-fluro-4-oxo-chloro-quinoline carboxyliacid

80 Octohydro pyro lo pyridine compound


800 D M Water 500 I P A 450 Ethyl Acetate

40 IPA + HCl

75 Kg Moxifioxine 1100 282 1260 35



Reciever

Reactor

Filter

Moisture removel

Collection Pit


Page no 168

54).Product Name: Meloxicam Charge Methyl benzothiazine amine, Hydroxy methyl thiazolyl T H F, K2CO3 heat and reflux distilled out IPA Add Methanol, Acetonitrilel cool & filters dry in RCVD to get Meloxicam

N

S

CH3

NH2

+S

N

O OCH3

OH

Cl

O

SN

O OCH3

OH

NH

OS

N

CH3

5-methyl-1,3-thiazol-2-amine 4-hydroxy-2-methyl-2H-1,2-benzothiazine-3-carbonyl chloride 1,1-dioxideMF: C4H6N2S

MW: 114.4 MF: C10H8SO4NClMW: 273.5

MF: C14H13N3O4S2

MW: 351.40

Meloxicam

MF: C4H6N2S MF: C10H8SO4NCl MF: C14H13N3O4S2 KCl+ +MW: 114.4 MW: 273.5 MW: 351.40 MW: 74.5

K2CO3MW:138.2

+ CO2

MW:44

KOH

MW:56+

K2CO3MW : 138.1


Page no 169

Qty Kgs


Output

100 Methyl benzothiazine amine

800 To recovery 70 Hydroxy methyl thiazolyl

500 T H F 45 K2 CO3

300 M D C 400 Aceto Nitrile

THF-500 MDC-300


Kgs Starting Material Kgs Product Kgs W aste 100 Methyl benzothiazine

amine

70 Hydroxy methyl thiazolyl

500 T H F 45 K2 CO3

300 M D C 400 Aceto Nitrile

70 Kg Meloxicam 200 300 820 25

To ETP Waste Waste Water Potassium Acetate Potassium Salt 2) To Recovery 3) Moisture Loss


Reciever

Reactor

Filter

Moisture removel

Collection Pit


Page no 170

55). Product Name: Lercandipine HCl Charge Di phenyl propy lamino compound, Nitrophenyl pyr idine di carboxalic acid, IPA, K2 CO3, PTS heat and reflux distilled out IPA Add Methanol, Ethyl Acetate, Con HCl cool & filters dry in RCVD to get Lercandipine HCl

NH

CH3

+

NH

N+

O-

O

CH 3CH3

OCH 3

O

O

OCH 3

CH3Cl

N-methyl-3,3-di phenylpropan-1-amine Nitrophenyl pyriidne dicarboxylic acid compound

MF: C16H19N

MW: 225MF: C20H23ClN2O6

NH

N+

O-

O

CH 3CH3

OCH 3

O

O

OCH 3

CH3N

CH3

MF: C36H41N3O6.HCl

MW: 390.5

K2CO3

C16H19N C20H23ClN2O6 C36H41N3O6.HClMW: 225 MW: 390.5 MW: 648.22

MW: 648.22

KCl+ +MW: 74.5

+ CO2

MW:44

KOH

MW:56+

K2CO3MW : 138.1


Page no 171

Qty Kgs


Output

80 Di phenyl propylamino compound

695 To recovery 100 Nitrophenyl pyridine di carboxalic acid

500 I P A 35 K2 CO3 10 PTS

35 Methanol

400 Ethyl Acetate

35 Con HCl


Kgs Starting Material Kgs Product Kgs W aste 80 Di phenyl propylamino

compound

100 Nitrophenyl pyridine di carboxalic acid

500 I P A 35 K2 CO3 10 PTS 35 Methanol

400 Ethyl Acetate 35 Con HCl

70 Kg Lercandipine HCl 150 250 695 30

To ETP Waste Waste Water Potassium Acetate Potassium Chlor ide 2) To Recovery 3) Moisture Loss


Reciever

Reactor

Filter

Moisture removel

Collection Pit


Page no 172

56). Product Name: Anastrazole Charge Tetrazole compound1, 3 Benzane, Dia acetronitrile-5-chloro methyl, Toluene, NaOH f lakes heat and reflux distilled out Toluene Add Cyclo Hexane, Ethyl Acetate cool & filters dry in RCVD to get Anastrazole

+ + NaOH + CYCLOHEXANE


Page no 173

Qty Kgs


Output

60 Tetrazole Compound

895 To recovery 100

1,3 Benzane diaacetronitrile-5-chloro methyl


500 Cyclo Hexane 400 Ethyl Acetate

HEXANE-485


Kgs Starting Material Kgs Product Kgs W aste 60 Tetrazole Compound

100 1,3 Benzane diaacetronitrile-5-chloro methyl


500 Cyclo Hexane 400 Ethyl Acetate

75Kg Anastrazole 300 300 895 35



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Page no 174

57). Product Name: Clom ipramine HCl Charge Chloro Iminodibenzyl Dimethyl amino propyl chlor ide, Toluene, KOH heat and reflux distilled out Toluene Add D M Water, Acetone, HCl cool & filters dry in RCVD to get Clomipramine HCl

NH Cl

+Cl N

CH3

CH3

3-chloro-10,11-dihydro-5H-dibenzo[b ,f]azepine 3-chloro-N,N-dimethylpropan-1-amine

MF: C14H12NCl MF: C5H12NCl

MW: 229.5 MW: 121.5

NCl

NCH3

CH3

MF: C19H20N2Cl.HCl

MW: 351.31

Clomipramine HCl

. HCl

KOH

C14H12NCl C5H12NCl+ C19H20N2Cl.HClKOH

KCl H2O+ +

MW: 229.5 MW: 121.5 MW: 351.31 MW: 74.5 MW: 18MW: 56

Stoichiometry:


Page no 175

Qty Kgs


Output

100 Chloro Iminodibenzyl

440 To recovery 85 Dimethyl amino propyl chloride

600 Toluene 40 KOH

1000 DM Water 250 Acetone

ACETONE-250

30 HCl 1230 Waste water


Kgs Starting Material Kgs Product Kgs W aste 100 Chloro Iminodibenzyl

85 Dimethyl amino propyl chloride

600 Toluene 40 KOH

1000 DM Water 250 Acetone

30 HCl

75Kg Clomipramine HCl 1230 135 200 440 25

To ETP Waste Waste Water Potassium salt Potassium Chlor ide 2) To Recovery 3) Moisture Loss


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Page no 176

58) Product Name: Letrozole Charge Triazol compound, Tanophenyl compound, I P A, NaOH Base heat and reflux distilled out IPA. Add DM water IPA Ethyl acetate, IPA+HCl cool & filters dry in RCVD to get Letrozole

N

NN

CN

+CN

F

4-fluorobenzonitrile

tBuOK

4-(1H-1,2,4-triazol-1-ylmethyl)benzon itr ile

THF

N

NN

NCCN

4,4'-(1H-1,2,4- triazol -1-ylmethanediyl)dibenzonitrile

Letrozole

MF: C10H8N4 MF: C7H4FN

MW: 121.1

MF: C17 H11N5

MW: 285.30

MW: 184.2

C10H8N4 C7H4FN C17H11N5

MW: 184.2 MW: 121.1 MW: 285.30

+ + HF

MW: 20

Stoichiometry:


Page no 177

Qty Kgs


Output

60 Triazol Compound

1075 To recovery 100 Tanophenyl compound

700 IPA 40 NaOH (Base)

400 Methanol 350 Acetonitrile

Acetonitrile-340


Kgs Starting Material Kgs Product Kgs W aste 60 Triazol Compound

100 Tanophenyl compound 700 IPA

40 NaOH (Base) 400 Methanol 350 Acetinitrile

76 Letrozole

230 240 1075 30

To ETP Waste Waste Water Sodium Sodium salt 2) To Recovery 3) Moisture Loss


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Page no 178

59) Product Name: Isradipine Charge Benzofurazamyl compound, Methyl ethyl ester, Dich loro dimethyl pyridine dicarboxiacid, Na OH Base, Methanol heat and reflux distilled out MethanolAdd Hexane, IPA cool & filters dry in RCVD to get Isradipine

NO

NCH3

OO

O

CH3

methyl 2-(2,1,3-benzoxadiazol-4-ylmethyl)-3-oxobutanoate

+

CH3

CH3O

NH2

CH3

O

propan-2-yl (2Z )-3-aminobut-2-enoate

NH

OCH3

O

OCH3

CH3 O

CH3 CH3

NO

N

Isradipine

MF: C12H12N2O4MW: 248.8

MF: C7H13NO2MW: 143.79

MF: C19H21N3O5

MW: 371.38

MF: C12H12N2O4 MF: C7H13NO2 MF: C19H21N3O5

MW: 248.8 MW: 143.79 MW: 371.38

H2O

MW: 18+ +

Stoichiometry:


Page no 179

Qty Kgs


Output

40 Benzofurazamyl Comp

900 To recovery 40 Methyl ethyl ester

100 Dich loro dimethyl pyridine dicarboxicacid

25 NaOH (Base) 400 Methanol

500 Hexane 300 IPA

Hexane-478


Kgs Starting Material Kgs Product Kgs W aste 40 Benzofurazamyl Comp 40 Methyl ethyl ester

100 Dich loro dimethyl pyridine dicarboxicacid

25 NaOH (Base) 400 Methanol 500 Hexane 300 IPA

75 Isradipine 400 900 30

To ETP Waste Waste Water Sodium Chlor ide 2) To Recovery 3) Moisture Loss


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Page no 180

60). Product name: Product Nam e: Bisoprolol Charge Isopropy l amino propanol, Iso propyl ethoxy-p-tolyl compound, IPA, KOH flakes, D M Water heat and reflux distilled out IPA. Add DM water Acetone, Fumaric Acid cool & filters dry in RCVD to get Bisoprolo l

OOCH3

CH3

OH

+OH NH CH3

CH3

OH

3-(propan-2-ylamino)propane-1,2-diol4-{[2-(propan-2-yloxy)ethoxy]methyl}phenol

Fumaric acid

MF: C12H18O3MW: 210

MF: C6H15O2N

MF: C4H4O4

MW: 133

MW: 116

OOCH3

CH3

O

NH CH3

CH3

OH

O

OH

OH

O

.

MF: C22H35NO8

MW: 441.52

Bisoprolol Fumarate

O

OH

OH

O

C12H18O3

MW: 210

C6H15O2N

MW: 133

C4H4O4MW: 116

C22H35NO8

MW: 441.52+ +

Stoichiometry:

H2OMW: 18+


Page no 181

Qty Kgs


Output

60 Isopropyl amino propanol

520 To recovery 100 Iso propyl ethoxy-p-

tolyl compound 450 IPA

30 KOH Flakes 15 DM Water

500 D M Water 300 Acetone

40 Fumaric Acid 725 Waste water


Kgs Starting Material Kgs Product Kgs W aste 60 Isopropyl amino

propanol

100 Iso propyl ethoxy-p-tolyl compound

450 IPA 30 KOH Flakes 15 DM Water

500 D M Water 300 Acetone

40 Fumaric Acid

80 Bisoprolo l Fumarate 725 130 520 40

To ETP Waste Waste Water Potassium Chlor ide 2) To Recovery 3) Moisture Loss


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Page no 182

61). Product Name: Olanzapine Charge Methyl piperazinyl Ch loro-thieno benzodiazepine, N N DMA, catalyst heat and reflux distilled out .Add Acetonitrile coo l & filters dry in RCVD to get Olanzapine

N

NH

S

Cl

CH3+

N

NH

CH3

1-methylpiperazine

MF: C12H9N2SCl

MW: 248.5

MF: C5H12N2MW: 100.43

N

NH

S

N

N

CH3

CH3

4-chloro-2-methyl-10H-thieno[2,3-b][1,5]benzodiazepine

MF: C17H20N4S

MW: 312.43

Olanzapine

Stoichiometry :

C12H9N2SCl

MW: 248.5

C5H12N2

MW: 100.43

C17H20N4S

MW: 312.43

HCL

MW: 36.5+ +


Page no 183

Qty Kgs


Output

80 Methyl piperaziny l

510 To recovery 100 Chloro-thieno

benzodiazepine

400 N N DMA 10 Catalyst

300 Acetonitrile


Kgs Starting Material Kgs Product Kgs W aste 80 Methyl piperaziny l

100 Chloro-thieno benzodiazepine

400 N N DMA 10 Catalyst

300 Acetonitrile

75 Olanzapine 280 510 25



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Page no 184

62). Product Name: Rosiglitazone Charge Methyl pyridinyl amino ethoxy phenyl in reactor and add 2,4 thiazo compound, IPA, Base heat and reflux distilled out IPA. Add methanol, Sodium Borohydride and 50% con HCl cool & filters dry in RCVD to get Rosiglitazone.

NH S

O

OCl

+

ON

CH3

N

5-(chloromethyl)-1,3-thiazolidine-2,4-dione N-methyl-N-(2-phenoxyethyl)pyridin-2-amine

MF: C4H4O2NSCl MF: C14H16ON2MW: 165.5 MW: 228.5

ON

CH3

NNH S

O

O

MF: C18H19O3N3S. HClMW: 393.92

HCl

. HCl

Rosiglitazone HCl

Stoichiometry :

C4H4O2NSCl

MW: 165.5

C14H16ON2

MW: 228.5

C18H19O3N3S. HCl

MW: 393.92+


Page no 185

Qty Kgs


Output

100 Methyl pyridinyl amino ethoxy phenyl

435 To recovery 70 2,4 Thiazo Compound

450 IPA 20 Base

100 Methanol

15 Sodium Borohydr ide 16 50% HCl


Kgs Starting Material Kgs Product Kgs W aste 100 Methyl pyridinyl amino

ethoxy phenyl 70 2,4 Thiazo Compound

450 IPA 20 Base

100 Methanol 15 Sodium Borohydr ide 16 50% HCl

75 Rosiglitazone 230 435 31

To ETP Waste Waste Water Sodium Chlor ide 2) To Recovery 3) Moisture Loss


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Page no 186

63) Product Name: Fentanyl Citrate Charge Phenyl piperidinyl compoundxy phenyl, Propinamide compound, THF, K3 CO3 and water heat and ref lux distilled out THF Add Acetone and citniacid cool & filters dry in RCVD to get Fentanyl Citrate

Cl

+NH N

CH3

O

(2-chloroethyl)benzene N-phenyl-N-(piperidin-4-yl)propanamide

N N

CH3

O

MF: C 8H9Cl

MW: 141.5

MF: C14H 20NO

MW: 232

MF: C 22H28N 2O.C 6H8O7

MW: 528.59

Fentanyl citrate

OH OH

O O

OH

O OH

Citric acid

OH OH

O O

OH

O OH

MF: C 6H8O7

MW: 192

Stoichiometry :

C 8H9Cl

MW: 141.5 C14H20NO

MW: 232

C 6H8O7

MW: 192C22H28N2O.C 6H 8O7

MW: 528.59+ +

MF: K2CO3MW: 138.1

Potasium Carbonate

K2CO3

MW: 138.1

KCL CO2 KOH

MW: 74.5 MW: 44 MW: 56+ +

++


Page no 187

Qty Kgs


Output

60 Phenyl piperidinyl compoundxy phenyl

650 To recovery 100 Propianamide

compound 500 THF

30 K3 CO3

10 Water

300 Acetone

THF- 495

25 Citniacid


Kgs Starting Material Kgs Product Kgs W aste 60 Phenyl piperidinyl

compoundxy phenyl

100 Propianamide compound

500 THF 30 K3 CO3 10 Water

300 Acetone 25 Citniacid

70 Fentanyl Citrate 130 150 650 25

To ETP Waste Waste Water Potassium Salt Potassium 2) To Recovery 3) Moisture Loss


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Page no 188

64). Product Name: Lacidipine Charge Ferbutoxy carboxyl compound, Mac, Aldehyde, Methanol, Base heat and reflux distilled out Methanol.Add Ethyl Acetate I P A cool & filters dry in RCVD to get Lacidip ine

CHO

CHO Ph3P=CH-COOtBuCHO

COOtBu

NH2 CH3

COOCH2CH3

CH3COOH

COOtBu

NH

O CH3OCH3

OO

CH3 CH3

MW: 455.54

Lacidipine

benzene-1,2-dicarbaldehyde

ethyl (2E)-3-aminobut-2-enoate


Page no 189

Qty Kgs


Output

45 Ferbutoxy carboxyl compound

920 To recovery 60 Mac

50 Aldehyde 500 Methanol

20 Base

600 Ethyl Acetate

450 IPA


Kgs Starting Material Kgs Product Kgs W aste 45 Ferbutoxy carboxyl

compound 60 Mac 50 Aldehyde

500 Methanol 20 Base

600 Ethyl Acetate 450 IPA

70 Lacidipine

410 300 920 25

To ETP Waste Waste Water Acetate 2) To Recovery 3) Moisture Loss


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Page no 190

65). Product Name: Venlafaxine HCl: Charge Formic Acid, VF2 Acetate, D M Water Formaldihyde Na OH K Flakes Ethyl Acetate heat and ref lux distilled out IPA cool & filters dry in RCVD get Venlafaxine HCl

NH2

OCH3

OH

HCOOHHCHO

N

OCH3

OH

CH3

CH3

O

N

OCH3

CH3

HCOONa

1-[2-amino-1-(4-methoxyphenyl)ethyl]cyclohexanol

MF: C15H23NO2

MW: 249

Venlafexine

MF: C17H27NO2MW: 277.40

MF: C15H23NO2

MW: 249

HCHO HCOOH

MW: 30 MW: 44

+ + MF: C17H27NO2

MW: 277.40

+ 3 H2O


Page no 191

(66).Product: Venlafaxine Material Flow Sheet:

Qty Kgs


Output

100 Formic Acid

110 VF2 Acetate

1000 D M Water 200 Formaldihyde

32 NaOH Flasks

150 Ethyl Acetate 800 Waste Water


Kgs Starting Material Kgs Product Kgs W aste 100 Formic Acid 110 VF2 Acetate

1000 D M Water 200 Formaldihyde

32 NaOH Flasks

70 Venlafaxine

800 200 341 31



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Page no 192

67)Product Name: Itopride:Charge Benzamide, Toluene, Na OH Flakes D M Water and IPA heat and ref lux distilled out IPA coo l & filters dry in RCVD to get Itopride

OH

NH

OCH3

OCH3

O

N-(4-hydroxybenzyl)-3,4-dimethoxybenzamide

+CH3

N

CH3

Cl

. HCl

N, N Dimethyl amino ethyl chloride Hydrochloride

NaOH

TBAB

O

NH

OCH3

OCH3

O

N

CH3

CH3

Itopride Base

O

NH

OCH3

OCH3

O

N

CH3

CH3

IPA.HCl

. HCl

Itopride Hydrochloride

MF: C16H17NO4MW: 287

MF: C4H10NCl.HCl

MW: 144

MF: C20H26N2O4

MF: C20H26N2O4.HCl

MW: 358

MW: 394.5

C16H17NO4 C4H10NCl.HCl+ C20H26N2O4 C20H26N2O4.HClNaOH HCl

MW: 287 MW: 144 MW: 358 MW: 394.5- NaCl- H2O

STOICHIOMETRY:


Page no 193

Product: Itopride Material Flow Sheet:

Qty Kgs


Output

125 Benzamide

800 300 Toluene

25 NaOH Flakes 500 D M Water 600 IPA

300 Waste Water


Kgs Starting Material Kgs Product Kgs W aste 125 Benzamide 300 Toluene

25 NaOH Flakes 500 D M Water 600 IPA

70 Itopride

300 100 250 800 30



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Page no 194

68) Product Name: Calcium Fructo Borate Brief Manufacturing Process: Charge D-Frucose, Dist water, Boric Acid, Calcium Carbonate and Acetone heat and reflux distilled out Acetone cool & filters dry in RCVD to get Calcium Fructo Borate

OH

OH OH

OH OH

O

CaCO3 B

OH

OH

OH

++

MF: C6H12O6

MW: 180.16

D-Fructose Calcium chloride Boric acidMF: B(OH)3

Ca[(C6H10O6)2B]2. 4H2O

MW: 61.83

MW: 521.7

CALCIUM FRUCTOBORATE

MW: 100.0


Page no 195

69).Product: C alcium Fructo Borate Material Flow Sheet:

Qty Kgs


Output

65 D-Frucose

250 To Recover 100 Dist Water

12 Boric Acid 10 Calcium Carbonate

325 Acetone

160 Waste Water

26

Moisture drying lost

Kgs Starting Material Kgs Product Kgs W aste 65 D-Frucose

100 Dist Water 12 Boric Acid 10 Calcium Carbonate

325 Acetone

71.00 Calcium Fructo Borate 165 250 26



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Page no 196

Qty Kgs


Output

100 Fluro Phenyl-hydroxy propyl compound

550 To recovery 60 Acetidinone Compound

45 Hydroxyphenyl compound

600 Aceto nitrile 100 NaOH Flakes


Kgs Starting Material Kgs Product Kgs W aste

100 Fluro Phenyl-hydroxy propyl compound

60 Acetidinone Compound

45 Hydroxyphenyl compound

600 Aceto nitrile 100 NaOH Flakes

80 Ezetimibe

244 550 31

To ETP Waste Waste Water Sodium SALT 2) To Recovery 3) Moisture Loss


Reactor

Filter

Moisture removal

Receiver

Collection Pit


Page no 197

70).Product: Meclizine Stage-01 (CMP)Material Flow Sheet:

Qty Kgs Inputs Reaction & Equipment Qty Kgs Out put 70 4-

CHLOROBENZOPHENONE

1.8 CAUSTIC SODA FLAKES

6.3 SODIUM BOROHYDRIDE

15 GLACIAL ACETIC ACID

545 HYDROCHLORIC ACID

85 CALCIUM CHLORIDE

670 TOLUENE


80 CAUSTIC SODA LYE

4540 PURIFIED WATER

600 Recovery of toluene

5720 Waste water 88 n-HEXANE

276 Methanol 65 Evopration

Loss

Moisture

drying lost

Kgs Starting Material Kgs Product Kgs Waste 70 4CHLOROBENZOPHE

NONE 1) To ETP waste:

1.8 CAUSTIC SODA FLAKES 5720 2) Waste Water 6.3 SODIUM

BOROHYDRIDE 15 GLACIAL ACETIC ACID

600 3) Recovery of toluene

545 HYDROCHLORIC ACID 65 4) Recovery loss 85 CALCIUM

CHLORIDE 20 5) Drying Loss

670 TOLUENE


80 CAUSTIC SODA L YE 4540 PURIFIED WATE R 88 n-HEXANE 276 Meth anol

70 Meclizine stage-01 (CMP)

6477.1 70 Total 6405 Total

Reactor

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Drying

Receiver

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Page no 198

Product: Meclizine Stage-02 (Meclizine HCl)Material Flow Sheet: Qty Kgs Inputs Reaction & Equipment Qty Kgs Out put

70


36.4 Triethyla mine (TE A)

36.4

3-Methylbenzylchloride


885 Acetone 1270 Toluene 1500 water

1140 665

Recovery of toluene Recovery of MDC

1612 Waste water

350 Evopration loss


Kgs Starting Material Kgs Product Kgs Waste 70


1) To ETP waste:

36.4 Triethyla mine (TE A) 1612 2) Waste Water

36.4 3-Methylbenzylchloride

1805 3) Recovery


350 4) Recovery loss

885 Acetone 1270 Toluene 15 5) Drying Loss 1500 water

80 Meclizine stage-02 (Meclizine HCl)

3863.8 Total 80 Total 3782 Total

Reactor

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Drying

Receiver

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Page no 199

APPENDIX-II (Probable products rawm aterial consumption) Name of Product Name of Raw Material C onsum ption in

Kg/ Product Aluminium Chloride 0.656 Aniline 0.424 Concentrated HCl 0.5 Charcoal 0.08 Ethyl Chloro cetate Mo.Methyl Chl. Acetate

0.544

2,6-dichloro phenol 0.722 Toluene/Ethoxy ethanol 2.2 Chloroacetyl ch loride 0.58 Sodium Methoxide Sol 1.82 Caustic Flakes/K2CO3 0.302 Caustic lye 0.275

Diclofenac Sodium

IPA 0.14 Aluminium Chloride 0.656 Aniline 0.424 Concentrated HCl 0.5 Charcoal 0.08 Ethyl Chloro Acetate 0.544 2,6-dichloro phenol 0.722 Toluene 2.2 Chloroacetyl ch loride 0.58 Sodium Methoxide Sol 1.82 Caustic Potash Flakes 0.302 Caustic lye 0.275


IPA 0.14 Aluminium Chloride 0.656 Aniline 0.424 Concentrated HCl 0.5 Charcoal 0.08 Ethyl Chloro Acetate 0.544 2,6-dichloro phenol 0.722 Toluene 2.2 Chloroacetyl ch loride 0.58 Sodium Methoxide Sol 1.82

Indolinone

Caustic lye 0.275 Ortho nitro benzaldehyde 1.5 Methyl Aceto Acetate 2.25 Methanol 13.7 Liq Ammonia 1.1

Nifedipine & Intermediates

Acetic acid 3.2 Epoxide intermediates 1.2 Fluconazole 1.2,4 Triazole 1.43 Pottasium Carbonate 0.175 Dimethyl formide 0.2


Page no 200

Water 2 Ethyl Acetate 2.4 IPA 1.5 Quinolic Acid 1.25 N-Methyl Piperazine 0.9 Butanol 1 Acetic Acid 0.3

Ofloxacin

Liquor Ammonia 0.45 Fluro-Quinolic Acid 1 Piperazine 0.68 Butanol 0.81 Hydrochloric Acid 1.26 Methanol 6.8 Acetic acid 0.86

Ciprof loxacin HCl

Caustic lye 1.16 L-2amino butyric acid 1.45 Thionyl Chlor ide 0.85 Ammonia 1.12

Levitiracitem

4 – Chloro butyl Chloride 0.35 2-Buty-4 Ch loro-5 hydroxy methyl imidazole

1.95

4-bro momethyl -2-cy anobiphenyl 1.01 Na Methoxide 3.1 Sodium azide 0.35 NH4 Cl 0.21 DMF 2.32

Losartan Potassium

Methanol + Water 2.79 N-[N2-Benzylo xycarbonyl-N6-tertiary buto xy carbonylLysyl]-L-Praline benylest er

1.36

Catalyst Hydrogenated 0.12 2-Oxo-4 Pheenyl Butyric acid

0.8

Sodium Hydroxide 1.1

Lisinopril

Methanol 2.33 1-[4- (Chlorophenyl) phenylmeth yl]piperier izine

1.82

L-Tartaric acid 0.62 (2- Chloroethoxy) Acetonitrile

1.45

Sodium Carbonate 0.35 KI 0.15 N-Butanol 2.25 Conc. HCl 0.32

Levocetrizine

E. Acetate 2.95 3- Chloro-4-[Carbonyl oxophenyl)ethyl] -1.3-dihydro-2-H-2- Indolinone

2.1 Ropin irole

Palladium Hydrogen 0.12


Page no 201

Caustic lye 0.45 N,N dipropylamine 0.95 Methanol 2.45 IPA 2.0 (2R-trans)-5 -(4-Fluoroph enyl)-2-(1-Methyl)-N,4diphenyl-1-[2Tetra hydroxyl-4 -hydro xy-6 -Oxo-2H-pyran-2 -yl)ethyl]-1 H-pyrrole-3-carbo xamide

1.91

IPA 2.25 NaOH 0.31 Calcium acetate solution 1.4

Atorvastatin Calcium

IPA 1.73 Amino Ester (VIII 2.82 )(+)-10-Camphorsulphon ic 1.85 Formic acid 0.33 Formaldehyde 1.17 Sulphuric acid 0.25 IPA+water 1.5

Clopididogril Bisulphate

Methanol 1.2 4-(3,4-Dichlorophenyl)-3,4-dihydro-1(2H)-naphtholene

1.42

Methyl amine 0.37 Lewis acidHydrogen 0.29 D(-) Mandelic acid 0.16 Conc. HCl 0.85

Sertraline HCl

Methanol + water 4.7 5H-Dibenz[b,f]azep ine-5-carbonitrile Sodium notrite

1.35

Acetic acid 0.68 Iron 0.08 Acetic acid 1.1 Boron Trifluoride 0.35

Oxcarbazepine

IPA 2.25 2-(2’ -aminomethyl Carbonyl Methoxyl)-7-Chloro-5-(2-Fluoro P henly)-1,3-dihydro-2H- 1,4- benzodiazepine

1.89

Triethyl orthoacetate 1.12 NaOH 0.27 Conc. HCl 1.09

Midazolam. Hcl

Methanol+Water 3.2 Benzopyran-2- CarboxaldehydeDerivative

1.4

Tri methyl sulfo xoniu m iodid e 1.15 Potassium hydrox ide 0.56 Benzyl amine 0.4 Toluene 3.0

Nebivo lol

A mmoniu m format e(Hyd rogen source) pd/C

0.6 0.01


Page no 202

Methanol 5.2 2-Cyano-4-amido benzotrifluoride 3.85 Hydrogen perox ide 0.12 4-Fluorobenzenethiol 0.95 Hydrogen perox ide 0.18 Acetic acid 1.1

Bicalutamide

IPA 2.25 Sod. Borohydride 1.2 KI 0.28 Intermediate -8 1.11 MIBK 2..85 Azycyclonol 0.60 Denat ured Spirit 1.0 Water 4.2

Fexofenadine

Methanol 3.50 5-Bromophthalide 0.84 4-Fluoropheny l Mg-brom ide in THF 4.62 dimethylaminopropyl magnesium chloride

3.2

toluene 6.0 HCl solution 30% 1.68 water 2.0 NaOH 3.69 CuCN 0.42 Phosphoric acid 3.36

Citalopram HBr

DMF 1.34 5-amino –isophthalic acid 0.529 Iodine monochloride 1.42 Potassium chloride 1.4 Sodium bisulphite 0.493 Methylene dichloride 4.69 Thionyl chloride 1.74 Ethyl acetate 26.57 Sodium bicarbonate 1.036 Sodium chloride 1.823 Toluene 3.55 L- Acetoxy P ropional Chloride 0.8 N,N-Dimethyl acetamide 10.74 Serino l 0.412 Triehtyl amine 0.66 Ammonia 2 Methanol 9.13 NaOH 0.35

Iopamidol

IPA 15.68 5-di f luoromethoxy)1 H-benzimidazo le-2-thiol

1.6 PANTAP ROZOL HCl

2- (Chloromethyl)-3,4dimethyl pyridine

1.3


Page no 203

NaOH 0.45 IPA 3 Ester compound 1 THF 2.5 NaOH 0.7 Methanol 0.5 Tataric acid 2

Montelucast

DMS 2.5 3-amino 5-benzoyl 2,4,6 triiodo benzoic acid

1

2-aminoethanol 1.1 Toluene 2 Triethyl amine 0.5 Methyl Amine 1 KOH 0.2

Ioxaglic Acid

IPA 3 Phathalic anhydride 1 Mono ethanol amine 0.4 O-Xylene 5 Toluene 8.7 Ethyl 4 chloro aceto acetate 0.86 Sodium Hydride 0.48 Acetic acid 0.43 O- Chlorobenzaldehyde 0.5 Methyl 3- amino crotonate 1.05 Methanol 3.5 IPA 3.7 Morpholine 0.06 Acetic acid 4.9 Monomethylamine 40% 0.57 Benzene sulphon ic acid 0.57

Amlodipine Besy late

IPA 14.5 Sorbitol 1 Methyl Amine 0.75

Maglumine

IPA 3 Dithiosalicylic acid 1.55 Sodium carbonate 0.857 4-Chlorotoluene 0.714 HCl 1.42 Ethanol 4.28

Lucanthone

Pyridine 0.8 2-MNI 1 Acetic acid 0.96 Acetic anhydride 0.06 Ethylene Oxide 1.3 Caustic lye 0.38 Liq Ammonia 1.33

Metronidazole

Sulphuric acid 1.24


Page no 204

Charcoal 0.00083 2,4,6 triiodo-3,5 diaminobenzoic acid

1

Acetic anhydride 3

Diatrizoic Acid

Sulphuric acid 0.5 1-(2,4 dichloropheny l)-2-imidazole-1 y l ethanol

1

Sodium hydr ide 0.22 Tetrahydrofuran 5 4-Chlorobenzyl chloride 0.6

Econazole

DMF 6 4- Chloro benzophenone 0.85 Piperizine 1.25 Methanol 3.45 HCl 7.635 Caustic flake 0.0225 Sodium Borohydr ide 0.0785 Acetic acid 0.1875 Toluene 8.375 Calcium chlor ide 1.06 Caustic lye 1 n-Hexane 1.1 1-[4-chlorophenyl(phenyl) methyl ]piperazine

0.875

Triethyl amine 0.455 Methyl benzoyl chlor ide 0.455

Meclizine

Acetone 11 Hexaethylene bis dicyndiamide 1 P-Chloroanilinehydrochloride 1.3 Ethoxy ethanol 7.1 Acetic acid 1

Chlorohexadine Gluconate

D-glucon ic acid 2 Dtpa 1.47 Gadolinium oxide 0.68

Gadopentetic Acid

IPA 0.5 DTPA anhydride 1.47 Gadolinium oxide 0.68

Gadodiamide

IPA 0.5 5 Ethyl 2 Phyridyl ethanol 1.10 Toluene 0.86 4-Hydroxy Benzaldehyde 1.06 Sodium Borohydrox ide 1.2 K2 CO3 0.20 Thiozolidinone 1.48 Caustic lye 0.7

Pioglitazone

IPA 2.50 Methanol 16.69 Cilinidipine 2-Methoxy Ethyl A ceto acetate 0.545


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IPA 15.075 Piperidine 0.0477 Nitrobenzaldehyde 0.567 Methanol 16.69 Cinramyl Aceto Acetate 0.681 Acetic acid 0.0545 Morpholinoethan sulphonic acid 0.00168 Ammonia 0.227

2- Methyl Imidazole Glyoxal 2.1 Ammonia solution 2.2 IPA/Iso Butanol 7

Acetaldehyde 2.3 P ara Hydroxy P henyl Acetamide 1.0 Sodium Hydroxide Flake 0.325 Epichloro hydrine 1.23 Mono Isopropyl Amine 5.52 Conc. HCl 0.5 NaoH Flakes 0.325 Acetic acid 0.39

Atenalol

Acetone 10.27 4-chloro benzophenone 1.15 Sodium borohydr ide 0.72 Methanol 3.26 NaOH 1.693 Conc. HCl 0.616 CaCl2 1.18 Toluene 6.142 Piperazine 1.441 TBAB 0.065 TEA 0.66 2-Chloroethanol 0.45 DMF 2.882 Sodium monochloroacetate 0.6 KOH 0.6 MDC 0.9

Cetrizine

Acetone 10.6 2-(ethoxyphenoxy)ethylamine 4-(2,3 epoxypropoxy)carbezole

0.52

2.4

Carvedilo l Mixture of purified water (5.11gm) and ethyl acetate (2.75 gm) 6.2 3-bromo-N,N-dimethyl-4-oxo-4-p-tolyl-butyramide

1.25

methyl isobutyl ketone 6.25 2-amino-5-methylpyridine 0.53 sodium bicarbonate .625 Methanol 2 L+Tartaric acid 0.6

Zolpidom

Acetone 2.5 Promedol HCl Trimeperidine 1


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HCl 0.4 Acetone 5 3 Methyl Pyridine 1.43 Piperazine 0.86 Ethyl Acetate 0.57

Indinavir NaOH Flakes 10.00

D M Water 14.29 IPA 5.71

Ethyl Acetate 4.29

Dipyrido Diazep ine 1.43 Eyclopropyl chloride 0.86 NaOH Flakes 0.57

Nevirapine Toluene 10

O Ccloro Pheny l Acetae 1.43 Thienopyridy l Compound 0.71 IPA 5.71 PTS 0.14 Methanol 5.71 H2 SO4 0.57

Clopidogrel Oil 1.14

Triazole Compound 1.25 Dimethyl amino Indo le 2.00 Catalyst 0.13 Acetinitrile 5.00

Rizatriptan Methanol 6.25

1,2 Cyclohexaneautic Acid 2.50 Urea 1.50 Toluene 12.50 NaOH Sol 0.63 D M Water 7.50 Methanol 10.00 Con HCl 0.88

Xabapentin IPA 10.00

Benzaimidazole compound 1.43 N Methyl-O-Phenyl ene diamine 1.21 Toluene 4.29 Poly Phosphoric Acid 3.57 Toluene 4.29

Telmisartan Bromoester 0.86

1,2,3,9 Tetra hydro 9 methyl-4H-Carbozole-4-one

1.33

N-(3 Chloro methyl)-2-methyl-Indiazole

1.00

Toluene 6.67 Phosphoric Acid 1.33 D M Water 9.33 IPA 4.00

Ondansetron

Con HCl 0.53 Candesartan Ethoxy benzimidazol e co mp 1.43


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Biphenyl Tetrazole 1.14 Toluene 7.14

KOH Flakes 0.50 D M Water 10.00 IPA 4.29

Con HCl 0.57

5-Methyl pyrazine-carboxamide 1.43 Sulfenyl Compound 1.14 Toluene 8.57 NaOH Flakes 0.43 PTS 0.21 D M Water 10.00 Ethyl Acetate 7.14 Methanol 3.57 Toluene 5.71

Glipizide Amino Cyclohexane 1.00

Oxo pyroline compound 1.43 Methyl cyclohexyl sulfonyl compound

0.79

Toluene 8.57 NaOH Flakes 0.36 PTS 0.21 D M Water 7.14 Ethyl Acetate 5.71

Glimepir ide

Methanol 5.00 Indolone Compound 1.33 Dipropyl Aminochlor ide 1.40 Toluene 8.00 PTS 0.20 D M Water 10.67

Ropinrole I P A 6.67

1cyclopropyl-6-fluro-4-o xo-chloro-quinoline carboxyliacid

1.33

Octohydro pyrolo pyridine compound

1.07

Toluene 10.00 NaOH Flakes 0.43 DM Water 10.67 I P A 6.67 Ethyl Acetate 6.00

Moxifioxine

IPA + HCl 0.53 Methyl benzothiazine amine 1.43 Hydroxy methyl thiazolyl 1.00 T H F 7.14 K2 CO3 0.64 MDC 4.29

Meloxicam Aceto Nitrile 5.71 Lercandipine HCl

Di pheny l propylamino compound

1.14


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Nitrophenyl pyridine di carboxalic acid 1.43 IPA 7.14 K2 CO3 0.50 PTS 0.14 Methanol 0.50 Ethyl Acetate 5.71

Con HCl 0.50 Tetrazole Compound 0.80 1,3 Benzane diaacetronitrile-5-chloro methyl

1.33

Toluene 6.67 NaOH Flakes 0.60 Cyclo Hexane 6.67

Anastrazole

Ethyl Acetate 5.33 Chloro Iminodibenzyl 1.33 Dimethyl amino propyl chloride 1.13 Toluene 8.00 KOH Flakes 0.53 DM Water 13.33 Acetone 3.33

Clomipramine HCl HCl 0.40

Triazol Compound 0.79 Tanophenyl compound 1.32 IPA 9.21 NaOH (Base) 0.53 Methanol 5.26

Letrozole Acetinitrile 4.61

Benzofurazamyl Comp 0.53 Methyl ethyl ester 0.53 Dichloro dimethyl pyridine dicarboxicacid

1.33

NaOH (Base) 0.33 Methanol 5.33 Hexane 6.67

Isradip ine

IPA 4.00 Isopropyl amino propano l 0.75 Iso propyl ethoxy-p-tolyl compound 1.25 IPA 5.63 KOH Flakes 0.38 DM Water 6.44 Acetone 3.75

Bisoprolo l Fumarate Fumaric Acid

0.50

Methyl piperazinyl 1.07 Chloro-thieno benzodiazepine 1.33 N N DMA 5.33 Catalyst 0.13

Olanzapine Acetonitrile 4.00 Rosiglitazone Methy l pyridinyl am ino ethoxy phenyl 1.33


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2,4 Thiazo Compound 0.93 IPA 6.00 NaOH (Base) 0.27 Methanol 1.33 Sodium Borohydr ide 0.20

50% HCl 0.21

Pheny l piperidiny l com poundxy phenyl 0.86 Propianamide compound 1.43 THF 7.14 K3 CO3 0.43 Water 0.14 Acetone 4.29

Fentanyl Citrate Citricacid 0.36

Ferbutoxy carboxyl compound 0.64 Mac 0.86 Aldehyde 0.71 Methanol 7.14 NaOH (Base) 0.29 Ethyl Acetate 8.57

Lacidipine IPA 6.43

D-Frucose 0.915 Dist Water 1.4 Boric Acid 0.169 Calcium Carbonate 0.14

Calcium Fructo Borate

Acetone 4.57 Benzamide 1.785 Toluene 4.285 NaOH Flakes 0.357

ITOPRIDE

IPA 8.57 1 – CHLOROMETHYL) 3-Methyl benzene

1.0

Piperizine 1.6 Methanol 3 HCL 0.1 4- Cholro phenyl pheny l methyl chloride

0.9

K2CO3 0.03 Meclizine Toluene 2


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APPENDIX-III

SAFETY, HEALTH AND ENVIRONMENT PO LICY It is the policy of the company to manufacture, handle and dispose of all substances and products without making unacceptable risks to human health or the environment.

We believe that all identified health hazards are containable and all accidents are preventable. Our policy is to maintain safety beyond compromise. We will comply with all applicable laws and regulations and endeavor to improve such minimum legal requirements. We have a responsibility to know potential hazards and to make known to all others as needed. Even if we discover a hazard after its known. Line organization shall assume responsibility for health and safety for its people and product at all times. Periodic audits will be done to get a feedback, a verification of all that is intended to be done to meet the objectives. We are committed to have continual improvement in SHE Management and performance. If it is noticed that the Product/s produced by us is unsafe with respect to Safety, Health & Environment; then management will immediately stop the respective production. Executive Director (Technical & Production) Rev iewed on 31st December 2013 Next review date: December 2015


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APPENDIX-IV CONSO LIDATED CO NS ENT & AUTHORIZATION

CC A – Amendm ent for ZLD


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CCA valid till 25/07/2018


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GPCB- “INC RESE IN PO LLUTION LO AD CERTIFICATE”


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FIGURE : 9 ENVIROMENTAL MANAG EMENT C ELL

GENERAL MANAGER PROD. & TECHNICAL

ENVIRONMENT & SAFETY OFFICER

Q.C. /QA MANAGER

CHEMIST EXECUTIVE/OFFICER /CHEMIST

CHEMIST

OPERATOR OPERATOR

EXECUTIVE DIRECTOR

SE.PRODUCTIONMANAGER

GENERAL MANAGER ENVIRONMENT

HEALTH & SAFETY

ENVIRONMENT EXECUTIVE


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APPENDIX-V

Compliance report for CCA am endment order no: AWH-79944


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C onsent order no: AWH-57529 dated 06/10/2013 compliance report Consolidated consent & authorization noAWH-57529 dated 06/10/2013 issued to M/ S.

Unique Chemicals (A div o f J B CHE MICALS & PHA RMACEUTICAL S L TD) v alid up to 25/07/2018.

Complian ce report for th e Consent o rder no: AWH-57529 is as under. 1. Consent o rder validity up to 25/07/2018. Co mpliance: Unit will apply fo r CCA renewal application three months befo re Validity over. 2. Consent o rder is issued for (43 no) Produ cts & total cap acity -78.02 MT/ month. Co mpliance: Unit h as manu factured products as p er Consent ord er & as per Consented Capacity. Unit will continue to manufacture product & capacity as per Consent order issued . 3. 3.1. The water consu mption quantity per day shall not exceeds 200 KL/day Compliance: Water consu mption by the unit is l ess than 200Kl/day & same will be Maintained . 3.2. The total quantity o f w aste water gen erated p er day sh all not exceeds 130.0KL/d ay (Do mestic-30 KL/day & Industrial -100 KL/day) Compliance: Unit will continue to maintain waste wat er g eneration quantityas per Consents o rder. 3.3. Sew age water sh all be disposed off through septic tank/ so ak pit syste, Compliance: Sewage w ater is disposed o ff th rough s eptic tank/ soak pit. 3.4. Unit shall affi x water met er as p er Section 4(1) o f Water Cess act-1977 for the purpose o f measuring & recording water consu med at such places. Compliance: Unit has fi xed water meter as p er requi rement. 3.5. 3.5.2 The effluent con fo rming to the standard shall be discharg ed in to GIDC underground d rainag e system and convey ed to FE TP which ulti mately leads to d eep sea fo r fin al disposal through BEAIL pipeline. Compliance: The unit is discharging treated waste wat er as p er pres cribed norms of FETP to GIDC collection su mp leads to FETP (NCTL ) fro m wh ere it is finally carried to d eep sea by pip eline. 3.5.3 The applicant sh all have to mak e storage facility for 48 hou rs. Compliance: Unit hav e already mad e arrangement for storag e of effluent for more than 48 hours . 3.5.4 The applicant sh all have to keep records of qu ality & quantity o f effluent discharge to FE TP. Compliance: Unit has fi xed a Magnetic flow meter & pH meter on discharge line. Treated effluent is tested & than discharg e to FE TP. 4. . 4.1. The following fuels should be us ed in the Boiler /DG set Compliance: In Boiler – Natu ral g as -7200 M3/day & DG s et – HSD 60Lit/hour for each DG s et is used . 4.2. Flue gas emission through stacks shall conform st andard. Compliance: Flue gas emissions fro m the stacks are confirming with prescribed standard 4.3. Process emissions through various stack /vents shall conform to the standard. Compliance: Process emissions fro m vents o f th e scrubber are con fi rming to the standard. 4.4. The con centration of parameter in ambient air within premises o f the industry sh all not exceed limits prescribed. Compliance: Con centration of v arious p arameters in ambient air remaining well within li mit prescribed 4.5. Compliance: The ai r pollution control equip ments are maintained efficiently &g aseous emissions always con forms to the standard speci fied . 4.6. Compliance: Necess ary port holes , ladd er & plat forms are provided for sampling & inspection o f air emissions. 4.7. Compliance: Ad equate measu res are tak en for Noise pollution like canopy . 5. 5.1. Compliance: Co mplied 5.2. Compliance: Co mplied 6. 6.1. Compliance: Hazardous waste gen erated fro m the unit, its collection, storag e , transportation & disposal are carried out as p er authorization issued by the board . Th e recovered material is send to actual end us ers as prescribed in the Consent order. 6.2. Compliance: Other conditions co mplied . 7. Compliance: Conditions 7.1 to 7.10 are complied.


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Factory License


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APPENDIX-VI FAC TORY LAYOUT

project pre-feasibility report on proposed project...

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