FORM-1
for
PROPOSED BULK DRUGS AND BULK DRUG INTERMEDIATES
MANUFACTURING UNIT
of
M/s. PGC DRUGS PVT. LTD.
Plot No. 6104/6, GIDC Industrial Estate,
Ankleshwar, Tal: Ankleshwar,
Dist: Bharuch-393002, Gujarat
Prepared by:
Aqua-Air Environmental Engineers Pvt. Ltd.
(Pollution Control Consultants & Engineers)
Reg. Office: 403, Centre Point, Nr. Kadiwala School, Ring Road,
Surat – 395 002, Gujarat, India Fax: +91 261 2707273 / 3987273
Tel: + 91 261 3048586 / 2460854 / 2461241
E-mail: [email protected] Visit us at: www.aqua-air.co.in
APPENDIX I
(See paragraph - 6)
FORM 1
Sr.
No.
Item Details
1. Name of the project/s M/s. PGC Drugs Pvt. Ltd. 2. S. No. in the schedule 5 (f)
3. Proposed capacity/area/length/tonnage to
be handled/command area/lease
area/number of wells to be drilled
Proposed Capacity: 75 MT/Month
For detail Please refer Annexure – I
4. New/Expansion/Modernization New
5. Existing Capacity/Area etc. Area: 3,200 m2
6. Category of Project i.e. ‘A’ or ‘B’ A
7. Does it attract the general condition? If yes,
please specify.
Yes. Located in critically polluted area
(Ankleshwar).
8. Does it attract the specific condition? If yes,
please specify.
No
9. Location
Plot/Survey/Khasra No. Plot No. 6104/6
Village GIDC Industrial Estate, Ankleshwar
Tehsil Ankleshwar
District Bharuch
State Gujarat
10. Nearest railway station/airport along with
distance in kms.
Railway Station: Ankleshwar (4 km)
Airport: Surat (65 km)
11. Nearest Town, city, District Headquarters
along with distance in kms.
Ankleshwar (4 Km)
12. Village Panchayats, Zilla Parishad, Municipal
Corporation, local body (complete postal
address with telephone nos. to be given)
Ankleshwar, Tal: Ankleshwar, Dist: Bharuch
(Gujarat)
13. Name of the applicant M/s. PGC Drugs Pvt. Ltd.
14. Registered Address Plot No.6104/6, GIDC Industrial Estate,
Ankleshwar-393002, Dist: Bharuch (Guj.)
15. Address for correspondence: Plot No. 7407, GIDC Industrial Estate,
Ankleshwar-393002, Dist: Bharuch (Guj.)
Name Mr. Ramesh Chodvadiya
Designation (Owner/Partner/CEO) Director
Address Plot No. 7407, GIDC Industrial Estate, Ankleshwar,
Dist: Bharuch (Guj.)
Pin Code 393002
E-mail [email protected]
Telephone No. --
Fax No. --
Mobile No. +919825205460
16. Details of Alternative Sites examined, if any.
Location of these sites should be shown on a
topo sheet.
NA
17. Interlinked Projects NA
18. Whether separate application of interlinked
project has been submitted?
NA
19. If yes, date of submission NA
20. If no, reason NA
21. Whether the proposal involves
approval/clearance under: if yes, details of
the same and their status to be given.
(a) The Forest (Conservation) Act, 1980?
(b) The Wildlife (Protection) Act, 1972?
(c) The C.R.Z. Notification, 1991?
No
22. Whether there is any Government
Order/Policy relevant/relating to the site?
No
23. Forest land involved (hectares) NA
24. Whether there is any litigation pending
against the project and/or land in which the
project is propose to be set up?
(a) Name of the Court
(b) Case No.
(c) Orders/directions of the Court, if any and
its relevance with the proposed project.
NA
• Capacity corresponding to sectoral activity (such as production capacity for manufacturing,
mining lease area and production capacity for mineral production, area for mineral exploration,
length for linear transport infrastructure, generation capacity for power generation etc.,)
(II) Activity
1. Construction, operation or decommissioning of the Project involving actions, which will cause
physical changes in the locality (topography, land use, changes in water bodies, etc.)
Sr.
No.
Information/Checklist confirmation Yes/No Details thereof with approximate
quantities frates, wherever possible)
with source of information data
1.1 Permanent or temporary change in land use,
land cover or topography including increase
intensity of land use (with respect to local
land use plan)
No Proposed project activity is within the
GIDC Industrial Estate- Ankleshwar.
1.2 Clearance of existing land, vegetation and
Buildings?
Yes Minor site clearance activities shall be
carried out to clear shrubs and weed.
1.3 Creation of new land uses?
No The project site is located on level
ground, which does not require any
major land filling for area grading
work.
1.4 Pre-construction investigations e.g. bore
Houses, soil testing?
No
1.5 Construction works?
Yes Please refer Annexure – II.
1.6 Demolition works? No
1.7 Temporary sites used for construction works
or housing of construction workers?
No
1.8 Above ground buildings, structures or
earthworks including linear structures, cut
and fill or excavations
Yes Please refer Annexure – II.
1.9 Underground works mining or tunneling?
No
1.10 Reclamation works?
No
1.11 Dredging?
No
1.12 Off shore structures?
No
1.13 Production and manufacturing processes?
Yes Please refer Annexure –III.
1.14 Facilities for storage of goods or materials?
Yes Proposed project activity is within the
Ankleshwar GIDC Industrial Estate. For
Proposed project, additional raw
material & finished products storage
area will be developed.
1.15 Facilities for treatment or disposal of solid
waste or liquid effluents?
Yes For details of liquid effluent, please
refer Annexure-V.
For Hazardous waste detail please
refer Annexure – VI.
1.16 Facilities for long term housing of operational
workers?
No
1.17 New road, rail or sea traffic during
Construction or operation?
Yes Addition of very few trucks per day.
1.18 New road, rail, air waterborne or other
transport infrastructure including new or
altered routes and stations, ports, airports
etc?
No
1.19 Closure or diversion of existing transport
routes or infrastructure leading to changes in
Traffic movements?
No
1.20 New or diverted transmission lines or
Pipelines?
No
1.21 Impoundment, damming, culverting,
realignment or other changes to the hydrology
of watercourses or aquifers?
No
1.22 Stream crossings? No
1.23 Abstraction or transfers of water form ground
or surface waters?
Yes Water requirement will be met
through Ankleshwar GIDC water
supply.
1.24 Changes in water bodies or the land surface
Affecting drainage or run-off?
No
1.25 Transport of personnel or materials for
construction, operation or
decommissioning?
Yes Transportation of personnel or raw
material and products will be primarily
by road & rail only.
1.26 Long-term dismantling or decommissioning
or restoration works?
No
1.27 Ongoing activity during decommissioning
which could have an impact on the
environment?
No
1.28 Influx of people to an area either
temporarily or permanently?
No
1.29 Introduction of alien species? No
1.30 Loss of native species or genetic diversity? No
1.31 Any other actions? No
2. Use of Natural resources for construction or operation of the Project (such as land, water,
materials or energy, especially any resources which are non-renewable or in short supply):
Sr.
No.
Information/checklist confirmation Yes/No Details thereof (with approximate
quantities /rates, wherever possible) with
source of information data
2.1 Land especially undeveloped or agricultural
land (ha)
No Proposed project activity will be within
GIDC Industrial Area, Ankleshwar, Dist:
Bharuch.
2.2 Water (expected source & competing users)
unit: KLD
Yes Water Source: Ankleshwar GIDC Water
Supply
For details please refer Annexure – IV.
2.3 Minerals (MT) No
2.4 Construction material - stone, aggregates,
and / soil (expected source - MT)
Yes Construction materials, like steel, cement,
crushed stones, sand, rubble, etc. will be
required for the project shall be procured
from the local market of the region.
2.5 Forests and timber (source - MT) No.
2.6 Energy including electricity and fuels (source,
competing users) Unit: fuel (MT), energy (MW)
Yes Please refer Annexure – VII.
2.7 Any other natural resources (use appropriate
standard units)
No
3. Use, storage, transport, handling or production of substances or materials, which could be
harmful to human health or the environment or raise concerns about actual or perceived risks
to human health.
Sr.
No.
Information/Checklist confirmation Yes/No Details there of (with approximate
quantities/rates, wherever possible) with
source of information data
3.1 Use of substances or materials, which are
hazardous (as per MSIHC rules) to human
health or the environment (flora, fauna, and
water supplies)
Yes Please refer Annexure –VIII.
3.2 Changes in occurrence of disease or affect
disease vectors (e.g. insect or water borne
diseases)
No
3.3 Affect the welfare of people e.g. by changing
living conditions?
No
3.4 Vulnerable groups of people who could be
affected by the project e.g. hospital patients,
children, the elderly etc.
No
3.5 Any other causes No
4. Production of solid wastes during construction or operation or decommissioning (MT/month)
Sr.
No.
Information/Checklist confirmation Yes/No Details there of (with approximate
quantities/rates, wherever possible)
with source of information data
4.1 Spoil, overburden or mine wastes No
4.2 Municipal waste (domestic and or commercial
wastes)
No
4.3 Hazardous wastes (as per Hazardous Waste
Management Rules)
Yes Please refer Annexure – VI.
4.4 Other industrial process wastes Yes
4.5 Surplus product No
4.6 Sewage sludge or other sludge from effluent
treatment
No
4.7 Construction or demolition wastes No
4.8 Redundant machinery or equipment No
4.9 Contaminated soils or other materials No
4.10 Agricultural wastes No
4.11 Other solid wastes Yes
Please refer Annexure – VI.
5. Release of pollutants or any hazardous, toxic or noxious substances to air (Kg/hr)
Sr. No. Information/Checklist confirmation Yes/No Details there of (with approximate
quantities/rates, wherever possible)
with source of information data
5.1 Emissions from combustion of fossil fuels
from stationary or mobile sources
Yes Please refer Annexure – VII.
5.2 Emissions from production processes Yes Please refer Annexure – VII.
5.3 Emissions from materials handling storage or
transport
No
5.4 Emissions from construction activities
including plant and equipment
No
5.5 Dust or odours from handling of materials
including construction materials, sewage and
waste
No
5.6 Emissions from incineration of waste No
5.7 Emissions from burning of waste in open air
e.g. slash materials, construction debris) No
5.8 Emissions from any other sources No
6.Generation of Noise and Vibration, and Emissions of Light and Heat:
Sr. No. Information/Checklist confirmation Yes/No Details there of (with approximate
quantities/rates, wherever possible) with
source of information data with source of
information data
6.1 From operation of equipment e.g. engines,
ventilation plant, crushers
Yes The Noise level will be within the prescribed
limit. At noisy areas adequate preventive &
control measures will be taken. No
significant noise, vibration or emission of
light & heat from the unit.
6.2 From industrial or similar processes Yes -Do-
6.3 From construction or demolition No
6.4 From blasting or piling No
6.5 From construction or operational traffic No
6.6 From lighting or cooling systems No
6.7 From any other sources No
7. Risks of contamination of land or water from releases of pollutants into the ground or into sewers, surface waters, groundwater, coastal waters or the sea:
Sr. No. Information/Checklist confirmation Yes/No Details there of (with approximate
quantities/rates, wherever possible) with
source of information data
7.1 From handling, storage, use or spillage of
hazardous materials
Yes Please refer Annexure – VIII.
7.2 From discharge of sewage or other effluents
to water or the land (expected mode and
place of discharge)
Yes For details please refer Annexure – V.
7.3 By deposition of pollutants emitted to air into
the and or into water
No
7.4 From any other sources No
7.5 Is there a risk of long term build up of
pollutants in the environment from these
sources?
No
8. Risk of accidents during construction or operation of the Project, which could affect human
health or the environment
S .No. Information/Checklist confirmation Yes/No Details there of (with approximate
quantities/rates, wherever possible)
with source of information data
8.1 From explosions, spillages, fires etc from
storage, handling, use or production of
hazardous substances
Yes Please refer Annexure –VIII.
8.2 From any other causes No
8.3 Could the project be affected by natural
disasters causing environmental damage
(e.g. floods, earthquakes, landslides,
cloudburst etc)?
No
9. Factors which should be considered (such as consequential development) which could lead to
environmental effects or the potential for cumulative impacts with other existing or planned
activities in the locality
Sr. No.
Information/Checklist confirmation
Yes/No
Details there of (with approximate
quantities/rates, wherever possible)
with source of information data
9.1 Lead to development of supporting. utilities, ancillary development or development stimulated by the project which could have impact on the environment e.g.
• Supporting infrastructure (roads, power
supply, waste or waste water treatment, etc.)
• housing development
• extractive industry
• supply industry
• other
Yes Please refer Annexure – IX.
9.2 Lead to after-use of the site, which could
have an impact on the environment
No
9.3 Set a precedent for later developments No
9.4 Have cumulative effects due to proximity to
other existing or planned projects with
similar effects
No
(II) Environmental Sensitivity
Sr. No. Areas Name/
Identity
Aerial distance (within 15 km.) Proposed
project location boundary
1 Areas protected under international
conventions, national or local legislation for
their ecological, landscape, cultural or other
related value
NA Proposed project site is within the GIDC
Industrial Estate, Ankleshwar.
2 Areas which important for are or sensitive Ecol
logical reasons - Wetlands, watercourses or
other water bodies, coastal zone, biospheres,
mountains, forests
NA
3 Area used by protected, important or sensitive
Species of flora or fauna for breeding, nesting,
foraging, resting, over wintering, migration
NA No protected area or sensitive species within 15
km from the proposed project boundary.
4 Inland, coastal, marine or underground waters Yes Amla Khadi = 6 Km
5 State, National boundaries NA N.A.
6 Routes or facilities used by the public for access
to recreation or other tourist, pilgrim areas
Yes Public transportation
7 Defense installations Yes Ankleshwar
8 Densely populated or built-up area Ankleshwar Ankleshwar City around 4 km from the
proposed project site.
9 Area occupied by sensitive man-made land uses
Hospitals, schools, places of worship,
community facilities)
No
10 Areas containing important, high quality or
scarce resources (ground water resources,
surface resources, forestry, agriculture,
fisheries, tourism, minerals)
No
11 Areas already subjected to pollution
environmental damage. (those where existing
legal environmental standards are exceeded)or
No NA
12 Areas susceptible to natural hazard which could
cause the project to present environmental
problems (earthquake s, subsidence ,landslides,
flooding erosion, or extreme or adverse climatic
conditions)
NO NA
IV). Proposed Terms of Reference for EIA studies: Please refer Annexure – X.
I hereby given undertaking that, the data and information given in the application and
enclosures are true to the best of my knowledge and belief and I am aware that if any
part of the data and information submitted is found to be false or misleading at any
stage the project will be rejected and clearance give, if any to the project will be revoked
at our risk and cost.
Date: January 31, 2017
Place: Ankleshwar
Ramesh Chodvadiya
(Director)
Signature of applicant with full name & Address
(Project Proponent/Authorized Signatory)
NOTE:
1. The projects involving clearance under Coastal Regulation Zone Notification, 1991 shall
submit with the application a C.R.Z. map duly demarcated by one of the authorized agencies,
showing the project activities, w.r.t. C.R.Z. (at the stage of TOR) and the recommendations of
the State Coastal Zone Management Authority (at the stage of EC). Simultaneous action shall
also be taken to obtain the requisite clearance under the provisions of the C.R.Z. Notification,
1991 for the activities to be located in the CRZ.
2. The projects to be located within 10 km of the National Parks, Sanctuaries, Biosphere
Reserves, Migratory Corridors of Wild Animals, the project proponent shall submit the map
duly authenticated by Chief Wildlife Warden showing these features vis-à-vis the project
location and the recommendations or comments of the Chief Wildlife Warden thereon (at the
stage of EC).
3. All correspondence with the Ministry of Environment & Forests including submission of
application for TOR/Environmental Clearance, subsequent clarifications, as may be required
from time to time, participation in the EAC Meeting on behalf of the project proponent shall
be made by the authorized signatory only. The authorized signatory should also submit a
document in support of his claim of being an authorized signatory for the specific project.
LIST OF ANNEXURES
SR. NO. NAME OF ANNEXURE
I List of Products and Raw materials along with their Production Capacity
II Layout Map of the Plant
III Brief Manufacturing Process Description
IV Details of water consumption & waste water generation
V Details of Effluent Treatment Scheme
VI Details of Hazardous Waste Generation and Disposal
VII Details of Stacks and Vents , Fuel & Energy Requirements
VIII Details of Hazardous Chemicals Storage & Handling
IX Socio-economic Impacts
X Proposed Terms of Reference
ANNEXURE-I
_______________________________________________________________________
LIST OF PRODUCTS ALONG WITH THEIR PRODUCTION CAPACITY WITH RAW MATERIALS
Sr. No. Product Proposed Quantity
(MT/Month)
Group-1
1 4-Sulfonamido Phenyl Hydrazine Hydrochloride
20
2 4,4,4-trifluoro-1-[4-(methyl)phenyl]-butane-
1,3-dione
3
4 - [ 5 - ( 4 - M e t h y l p h e n y l ) - 3 - ( t r i f l u o r o
m e t h y l ) p y r a z o l - 1 -
y l ] b e n z e n e s u l f o n a m i d e C e l e c o x i b
4 4 Chloro Phenyl Hydrazine
5 7-(1,3-Dioxolan-2-ylmethyl)-1,3-dimethyl purine-2,6-
dione Doxofylline
Group-2
6 2-(tert-Butylamino)-1-(3-chlorophenyl) propan-1-one
Bupropion hydrochloride
10
7 6-Methyl pyridine-3 yl-2,4-Methylsulfonyl phenyl
Etanone (Ketosulfone)
8 5 - C h l o r o - 6 ' - m e t h y l - 3 - [ 4 -
( m e t h y l s u l f o n y l ) p h e n y l ] - 2 , 3 ' - b i p y r i d i n e
E t o r i c o x i b and It’s Intermediates
9 2-(2-Fluorobiphenyl-4-yl)propanoic acid Flurbiprofen
and It’s Intermediates
10 Benzamide 5-chloro-N-[2-[4-
[(cyclohexylamino)carbonyl]
amino]sulfonyl]phenyl]ethyl]-2-metoxy
Glibenclamide and It’s Intermediates
11 D i b e n z o [ b , f ] [ 1 , 4 ] T h i a z e p i n - 1 1 ( 1 0 H ) - O n e
12 2-[2-(4-dibenzo [b,f] [1,4]thiazepin-11-yl-1-
piperazinyl)ethoxy]-ethanol Quetiapine fumarate and
It’s Intermediates
Group-3
13
N-{2-[4-(aminosulfonyl)phenyl]ethyl}-3-ethyl-
4methyl- 2-oxo-2,5-dihydro-1H-pyrrole-1-
carboxamide [Glimepiride Sulphonamide] 5
14
3-Ethyl-4-methyl-N-[2-(4-{[(trans-4-methylcyclohexyl)
carbamoyl]sulfamoyl}phenyl)ethyl]-2-oxo-2,5-
dihydro-1H-pyrrole-1-carboxamide Glimepiride and
It’s Intermediates
15
m-Hydroxy-alpha-(methylaminomethyl) benzyl
alcohol Phenyl ephrine hydrochloride and It’s
Intermediates
16
3-ethyl 5-methyl 2-[(2-aminoethoxy)methyl]-4-(2-
chlorophenyl)-6-methyl-1,4-dihydropyridine-3,5-
dicarboxylate Amlodipine besylate and It’s
Intermediates
Group-4
17
1 0 , 1 1 - d i h y d r o - 1 0 - o x o - 5 H -
d i b e n z ( b , f ) a z e p i n e - 5 - c a r b o x a m i d e
O x c a r b a z a p i n e
30 18 2, 3-Dibenzoyl-D-tartaric acid (DBDT)
19 p Anisic Alcohol
20 2-Chloro-1,3-bis (dimentylamino)trimethinium
hexafluorophosphate)
Group -5
21 5-Bromo-N-(4,5-dihydro-1H-imidazol-2-yl) quinoxalin-
6-amine Brimonidine tartrate and It’s Intermediates
10
22
( S ) - N - { ( 3 , 4 - D i m e t h o x y b e n z o c y c l o b u t - 1 -
y l ) } - N - ( m e t h y l ) ] - N - ( m e t h y l ) a m i n e
I v a b r a d i n e and It’s Intermediates
23 Trifluoro Methyl Cinnamic Acid
24
((R)-N-[1-(1-naphthyl)ethyl]-3-[3-
(trifluoromethyl) phenyl]propan-1-amine
Cinacalcet hydrochloride and It’s Intermediates
25
1 - { 4 - [ 2 - I s o p r o p o x y e t h o x y ) m e t h y l ]
p h e n o x y } - 3 - ( i s o p r o p y l a m i n o ) p r o p a n o l
B i s o p r o l o l f u m a r a t e and It’s Intermediates
26 5-Methyl-1-phenylpyridin-2(1H)-one Pirfenidone and
It’s Intermediates
27 Ursodeoxycholic acid and It’s Intermediates
Total 75
RAW MATERIAL CONSUMPTION
Sr. No. Raw Material Quantity (MT/Month)
1 4-Sulfonamido Phenyl Hydrazine Hydrochloride
Sulfanilamide 16.20
Sodium Nitrite 7.00
Sodium bisulphite 10.60
Conc HCl 34.00
2 4,4,4-trifluoro-1-[4-(methyl)phenyl]-butane-
1,3-dione
Sodium Methoxide 5.60
Toluene 30.00
4-Methylacetophenone 12.00
Methyltrifluoroacetate 12.40
Conc HCl 11.60
3 Celecoxib
4-Sulfonamido Phenyl Hydrazine Hydrochloride 14.00
4,4,4-trifluoro-1-[4-(methyl)phenyl]-butane-
1,3-dione 13.00
Toluene 56.00
Carbon 0.10
4 4 Chloro Phenyl Hydrazine Hydrochloride
4-Chloro Aniline 15.75
Sodium Nitrite 10.00
Sodium bisulphite 13.75
Conc HCl 41.20
5 Doxofylline
Theofylline 17.40
2-Bromomethyl-1,3-dioxolane 16.20
Sodium Carbonate 5.60
Dimethyl Formamide (DMF) 48.00
Carbon 0.20
6 Bupropion Hydrochloride and It’s Intermediates
Toluene 25.00
3-Chloro-2’-Bromo Propiophenone 10.00
tert butyl amine 3.50
20% Methanolic HCl 8.13
Iso Propyl Alcohol 20.00
Carbon 0.25
7 Ketosulfone
4 Methyl thiophenyl acetonitrile 6.40
Toluene 9.60
Sodium Methoxide 3.20
Methyl 6 Methyl Nicotinate 5.90
Methanol 6.00
Sodium Tangustate 0.10
Hydrogen Peroxide 6.40
Conc Sulfuric Acid 0.20
8 Etoricoxib and It’s Intermediates
Ketosulfone 8.50
DMF 25.00
CDT Salt 9.30
Potassium tert Butoxide 4.30
Toluene 20.00
Acetic Acid 3.00
IPA 15.00
Carbon 0.30
9 Flurbiprofen and It’s Intermediates
2,4-Difluoronitrobenzene 8.75
Diethyl methyl malonate 9.50
Sodium Hydroxide 7.88
DMF [Dimethyl formamide ] 9.75
Toluene 53.75
Palladium Catalyst 0.18
Hydrogen 0.45
Methanol 28.75
Benzene 6.63
Copper Powder 1.45
Sodium Nitrile 4.88
Acetic Acid 4.50
Conc HCl 26.75
Carbon 0.13
10. Glibenclamide and It’s Intermediates
Sulfonamide Deri 8.13
Ammonia 12.50
Cyclo Hexyl Isocyanate 2.75
Acetone 81.25
Sodium Hydroxide 1.25
Conc HCl 4.38
Carbon 0.50
11 Dibenzo[b,f][1,4]Thiazepin-11(10H)-One
2 Amino phenyl phenyl sulfide 9.50
Poly Phosphoric Acid PPA 30.00
Ethyl Chloro formate 6.25
12 Quetiapine and It’s Intermediates
Dibenzo-1,4-thiazepine one 5.75
Thionyl chloride 5.00
Toluene 25.00
Piperazin ethoxy ethanol 4.63
Ethanol 30.00
Fumaric Acid 1.50
Acetic Acid 1.00
13 N-{2-[4-(aminosulfonyl)phenyl]ethyl}-3-ethyl-4-
methyl-2-oxo-2,5-dihydro-1H-pyrrole-1-carboxamide
(Glimepiride Sulfonamide)
3 Ethyl methyl Pyrroline 5.00
2 Phenyl ethyl isocyanate 3.00
Toluene 50.00
Chloro Sulfonic Acid 3.75
Ammonia Solution 20.00
EDC [ethylene di chloride] 8.13
14 Glimepiride and It’s Intermediates
N-{2-[4-(aminosulfonyl)phenyl]ethyl}-3-ethyl-4-
methyl-2-oxo-2,5-dihydro-1H-pyrrole-1-carboxamide
(Solfonamide Derivative)
5.00
Trans Iso Cyanate 3.00
Acetone 50.00
Potassium Carbonate 3.75
Methanol 20.00
Conc HCl 8.13
Carbon 0.13
15 Phenyl Ephrine and It’s Intermediates
m Hydroxy Acetophenone 5.63
Ethyl Acetate 8.25
Bromine 7.00
Toluene 28.25
N Methyl benzyl Amine 9.13
IPA.HCl 5.25
Palladium carbon 0.20
Methanol 16.75
Liq Ammonia 11.50
L Tartaric Acid 5.65
IPA 11.63
Acetic Anhydride 5.50
Sulfuric Acid 1.18
Methanolic HCl 5.00
Carbon 0.13
16 Amlodipine Besylate and It’s Intermediates
Phthaloyl Amlodipine 5.44
Mono Methyl Amine 8.38
Methanol 21.88
Ethyl Acetate 15.44
Benzene Sulfonic Acid 1.88
Carbon 0.38
17 Oxcarbazapine
10-Metoxy benz(b,f)azepine 28.20
Sodium cynate 9.00
Toluene 66.00
Acetic acid 3.60
Conc HCl 14.40
Methanol 60.00
Carbon 0.30
18 2,3-Dibenzoyl-D-tartaric acid (DBDT)
Benzoyl Chloride 26.75
D Tartaric Acid 15.75
Toluene 45.00
19 p Anisic Alcohol
4 Methoxy Benzaldehyde 29.94
Nickel Catalyst 0.15
Hydrogen gas 8040 M3
Nitrogen 597 M3
20 2-Chloro-1,3-bis(dimentylamino)trimethinium
hexafluorophosphate (CDT Salt)
Dimethylformamide 10.70
Chloroacetyl chloride 12.00
Phosphorus Oxychloride 16.50
Caustic Flakes 20.00
hexafluorophosphoric acid 27.00
21 Brimonidine Tartrate and It’s Intermediates
Chorobenzene 80.00
5-Bromo-6-thiouredo quinoxaline 8.00
Ethylene diamine 5.00
Isopropyl alcohol 20.00
20% HCl 40.00
20% Caustic Lye dilute 80.00
Methanol 90.00
L Tartaric Acid 5.50
Carbon 1.00
22 Ivabradine and It’s Intermediates
Potassium Carbonate 2.40
Acetone 20.00
3-(3-Iodopropyl)-7,8-dimethoxy-1,3-dihydro-2H-3-
benzazepin-2-one (IDDB) 9.00
1-[(7S)-3,4-Dimethoxybicyclo[4.2.0]octa-1,3,5-trien-7-
yl]-Nmethylmethanamine hydrochloride (MBC.HCl) 6.00
Toluene 30.00
Palladium on Carbon 0.80
IPA [iso propyl alcohol] 12.00
Conc HCl 15.00
Methanol 60.00
Carbon 1.00
23 Trifluoro methyl Cinnamic Acid
3 Trifluoromethyl Aniline 8.00
Conc HCl 13.30
Sodium Nitrite 4.00
Acrylonitrile 2.90
Caustic Flakes 2.50
Conc Sulfuric Acid 3.50
24 Cinacalcet and It’s Intermediates
Trifluoro methyl Cinnamic acid 7.50
Methanol 30.00
Raney Nickel 1.30
Toluene 15.00
Boric Acid 0.30
Naphthyl ethyl amine 5.80
Sodium Borohydride 1.80
MDC 7.50
Conc HCl 12.50
Carbon 0.80
25 Bisoprolol Fumarate and It’s Intermediates
4-hydroxy benzyl alcohol 3.75
2- Isopropoxy ethanol 3.50
Amberlyst-15 (Resins) 1.25
Sodium Carbonate 3.50
Sodium Hydroxide 1.50
Epichlorohydrin 2.88
Toluene 27.5
Sodium borohydride 0.38
Methanol 31.25
Isopropyl amine 2.75
MDC [Methylene dichloride] 21.25
Acetone 40.00
Fumaric Acid 3.25
Carbon 0.30
26 Pirfenidone and It’s Intermediates
Dimethylformamide 22.50
Bromobenzene 10.80
Potassium Carbonate 5.50
5-Methyl-1H-pyridin-2-one 1.90
Copper Oxide 7.00
Toluene 16.00
Sodium Hydroxide 3.00
Conc HCl 9.00
27 Ursodeoxycholic acid and It’s Intermediates
3-hydroxy-7-ketocholanic acid 10.80
Butanol 22.50
Sodium metal 1.50
Phosphoric acid 85% 9.30
Imidazole 2.30
Methanol 47.50
Sodium Hydroxide 1.50
Conc HCl 10.50
ANNEXURE-II
_______________________________________________________________________
LAYOUT OF MAP OF THE PLANT
ANNEXURE-III
_______________________________________________________________________
BRIEF MANUFACTURING PROCESS DESCRIPTION
1 . P r o d u c t : 4-Sulfonamido Phenyl Hydrazine Hydrochloride ( 4 S P H )
Ø A ) R e a c t i o n C h e m i s t ry
MW 219.65
Intermediate Step
SO2NH2
NH2
MW 172.20
Sulfanilamide
NaNO2+ + 2 HCl
MW 68.99MW 36.46
2 H2O+ + NaCl
MW 18.02
MW 58.44
SO2NH2
N+
NCl
-
MW 223.68
4 SPH
SO2+
MW 64.06
SO2NH2
NHNH2
ClH
NaHSO3+ + HCl
MW 104.04
MW 36.46
H2O
MW 18.02
+
NaCl
MW 58.44
O2 +
MW 32.00
+
Ø B ) P r o c es s F l o w D i a g r am
Sulfanilamide
Sodium Nitrite
Conc HCl
Sodium Bisulfite
Water
S T A G E Efflulent
Process Emissions
F I N I S H
P R O D U C T
Ø C ) M a n u f a c t u r i n g P r o c e s s
• Charged hydrochloric acid, water and sulphonilamide in Reactor at RT. Cool the RM
• Charged aqueous sodium nitrite in above reaction mixture
• Charged Slowly aqueous sodium bisulphite in above reaction mixture
• The reaction mixture was heated and stirred
• Hydrochloric acid was added to the reaction mixture
• The reaction mixture was cooled.
• The separated solid was filtered and dried.
Ø D ) S u m m a ry o f M a s s
Capacity, Mt/Month : 20.00
Batch Size, Kg : 400
Working Days : 26
Sr.
No Name of Raw Material Kg/batch
Kg/Kg of
Product MT/Month Remarks
Input
1 Sulfanilamide 325 0.81 16.20
2 Sodium Nitrite 140 0.35 7.00
3 Sodium bisulphite 210 0.53 10.60
4 Water 400 1.00 20.00
5 Conc HCl 680 1.70 34.00
Total 1755
Output
1 Final Product* 400 1.00 20.00 Finished product
4 Loss 185 0.46 9.25
5 Effluent 1170 2.93 58.50
Total 1755
2. P r o d u c t : 4,4,4-trifluoro-1-[4-(methyl)phenyl]-butane-1,3-dione
[Dione]
Ø A ) R e a c t i o n C h e m i s t ry
CH3
O CF3
O
MW 230.18
Dione deri
COCH3
CH3
MW 134.17
4 Methyl Acetophenone
F3C O
O
CH3
MW 128.05
Methyl Trifluoro Acetate
++ OH
CH3
MW 32.04
Methanol
Ø B ) P r o c es s F l o w D i a g r am
Methyl trifluoro Acetate
4 Methyl Acetophenone
Toluene
Sodium Methoxide
Conc HCl
Water
S T A G E
Solvent Recovery
Evaroparation Loss
Efflulent
F I N I S H
P R O D U C T
Ø C ) M a n u f a c t u r i n g P r o c e s s
• Charged Sodium methoxide and toluene in Reactor at RT.
• A solution of 4-methylacetophenone in toluene was added in above reaction mixture
• A solution of methyltrifluoroacetate in toluene was added slowly
• The reaction mixture was heated and stirred well
• The reaction mixture was cooled
• Charged aqueous hydrochloric acid toluene in in above reaction mixture
• The layers were separated
• The organic layer were washed with water
• The solvent was removed completely under vacuum to afford the title compound
Ø D ) S u m m a ry o f M a s s
Capacity, Mt/Month : 20.00
Batch Size, Kg : 400
Working Days : 26
Sr.
No Name of Raw Material Kg/batch
Kg/Kg of
Product MT/Month Remarks
Input
1 Sodium Methoxide 110 0.28 5.60
2 Toluene 600 1.50 30.00
3 4-Methylacetophenone 240 0.60 12.00
4 Methyltrifluoroacetate 248 0.62 12.40
5 Water 300 0.75 15.00
6 Conc HCl 230 0.58 11.60
Total 1728
Output
1 Final Product* 400 1.00 20.00 Finished product
2 Toluene (Recd) 580 1.40 28.00 Recycle
3 Distillation Loss 20 0.10 2.00
4 Effluent 718 1.79 35.90
5 Residue 10 0.03 0.50
Total 1728
3 . P r o d u c t : 4 - [ 5 - ( 4 - M e th y l p h e n y l ) - 3 - ( t r i f l u o r o m e t h y l )
p y r a z o l - 1 - y l ] b e n z en e s u l f o n a m i d e: C e l e c o x i b
SO2NH2
N
N
CH3
CF3
MW 381.37
4-[5-(4-Methylphenyl)-3-(trifluoro methyl) pyrazol-1-yl]benzenesulfonamide celecoxib
Water
Toluene
MW 223.68
4 SPH
SO2NH2
NH
NH2
ClH
CH3
O CF3
O
MW 230.18
Dione deri
+
+ ClH + 2 H2O
MW 36.46 MW 18.01
Ø B ) P r o c es s F l o w D i a g r am
4 SPH
Dione Deri
Toluene
Carbon
Water
S T A G E
Solvent Recovery
Evaroparation Loss
Efflulent
Solid Waste
F I N I S H
P R O D U C T
Ø C ) M a n u f a c t u r i n g P r o c e s s
• Charged water in Reactor at RT.
• Charged 4 SPH and Dione Deri in Reactor
• The reaction mixture was heated and stirred well.
• Cool the RM and Filter the Product.
• Charged Toluene and wet cake in above reactor again.
• Heat the RM and stir well for several time
• The organic layer were washed with water add Activated carbon at stirred under
heating.
• Filter the RM with Sparkler
• The filtrate was cooled.
• The separated solid was filtered and dried
Ø D ) S u m m a ry o f M a s s
Capacity, Mt/Month : 20.00
Batch Size, Kg : 500
Working Days : 26
Sr.
No Name of Raw Material Kg/batch
Kg/Kg of
Product MT/Month Remarks
Input
1 4 SPH 350 0.70 14.00
2 Dione Deri 325 0.65 13.00
3 Toluene 1400 2.80 56.00
4 Carbon 5 0.01 0.10
5 Water 800 1.60 32.00
Total 2875
Output
1 Final Product 500 1.00 20.00 Finished product
2 Toluene (Recd) 1350 2.65 53.00 Recycle
3 Distillation + Drying Loss 50 0.19 3.80
4 Residue 15 0.03 0.60
5 Carbon Waste 10 0.02 0.20
6 Effluent 940 1.88 37.60
Total 2875
4 . P r o d u c t : 4 - C h l o r o P h e n y l H y d r a z i n e H y d r o c h l o r i d e
Ø A ) R e a c t i o n C h e m i s t ry
MW 175.03
Intermediate Step
Cl
NH2
MW 127.57
4-Chloro Aniline
NaNO2+ + 2 HCl
MW 68.99MW 36.46
2 H2O+ + NaCl
MW 18.02
MW 58.44
Cl
N+
NCl
-
MW 179.05
4-Chloro Phenyl Hydrazine Hydrochloride
SO2+
MW 64.06
Cl
NHNH2
ClH
NaHSO3+ + HCl
MW 104.04
MW 36.46
H2O
MW 18.02
+
NaCl
MW 58.44
O2 +
MW 32.00
+
Ø B ) P r o c es s F l o w D i a g r am
4-Chloro Aniline
Sodium Nitrite
Conc HCl
Sodium Bisulfite
Water
Efflulent
Process Emissions
F I N I S H
P R O D U C T
S T A G E
1
Ø C ) M a n u f a c t u r i n g P r o c e s s
• Charged hydrochloric acid, water and 4 Chloro Aniline in Reactor at RT. Cool the RM
• Charged aqueous sodium nitrite in above reaction mixture
• Charged Slowly aqueous sodium bisulphite in above reaction mixture
• The reaction mixture was heated and stirred
• Hydrochloric acid was added to the reaction mixture
• The reaction mixture was cooled.
• The separated solid was filtered and dried.
Ø D ) S u m m a ry o f M a s s
Capacity, Mt/Month : 20.00
Batch Size, Kg : 400
Working Days : 26
Sr.
No Name of Raw Material Kg/batch
Kg/Kg of
Product MT/Month Remarks
Input
1 4-Chloro Aniline 315 0.79 15.75
2 Sodium Nitrite 200 0.50 10.00
3 Sodium bisulphite 275 0.69 13.75
4 Water 400 1.00 20.00
5 Conc HCl 825 2.06 41.20
Total 2015
Output
1 Final Product 400 1.00 20.00 Finished product
4 Drying loss 320 0.80 16.00
5 Effluent 1295 3.24 64.80
Total 2140
5 . P r o d u c t : 7-(1,3-Dioxolan-2-ylmethyl)-1,3-dimethyl purine-2,6-dione :
Doxofylline
Ø A ) R e a c t i o n C h e m i s t ry
STAGE 1 : 7-(1,3-Dioxolan-2-ylmethyl)-1,3-dimethyl purine-2,6-dione doxofylline
2-Bromomethyl-1,3-dioxolane
MW 180.16
N
N
CH3
N
H
NO
CH3
O
Theofylline
MW 266.25
7-(1,3-Dioxolan-2-ylmethyl)-1,3-dimethyl purine-2,6-dione doxofylline
MW 167.00
+
Br
OO
N
N
CH3
N
NO
CH3
O
O
O
Na2CO
3
NaBr+
MW 102.89
Sodium
Bromide
CO2+
MW 44.01
H2O
MW 18.01
+
Ø B ) P r o c es s F l o w D i a g r am
Theofyline
2-Bromomethyl-1,3-dioxolane
Dimethyl formamide
Sodium Carbonate
Water
Carbon
S T A G E
Solvent Recovery
Evaroparation Loss
Process Emissions
Effluent
Carbon waste
F I N I S H
P R O D U C T
Ø C ) M a n u f a c t u r i n g P r o c e s s
• Charged DMF and Theofylline in Reactor at RT
• Charged 2-Bromomethyl-1,3-dioxolane in above reaction mixture
• The reaction mixture was heated and stirred
• The reaction mixture was cooled.
• Remove excess of solvent under vacuum.
• Now warm the reaction mass and add water in mass.
• Add carbon in above reaction mass and stir well under heating
• Filter the above mass in hot condition
• Cool and then Chilled the reaction mixture
• Maintain same temp for 4 hrs.
• Filter the solid mass and dry it.
Ø D ) S u m m a ry o f M a s s
Capacity, Mt/Month : 20.00
Batch Size, Kg : 750
Working Days : 26
Sr.
No Name of Raw Material Kg/batch
Kg/Kg of
Product MT/Month Remarks
Input
1 Theofylline 650 0.87 17.40
2 2-Bromomethyl-1,3-
dioxolane 610 0.81 16.20
3 Sodium Carbonate 210 0.28 5.60
4 Dimethyl Formamide (DMF) 1800 2.40 48.00
5 Water 1100 1.47 29.40
6 Carbon 10 0.01 0.20
Total 4380
Output
1 Final Product 750 1.00 20.00 Finished product
2 Dimethyl Formamide (DMF) 1740 2.32 46.40 Recycle
3 Distillation + Drying loss 135 0.18 3.60
4 Effluent 1740 2.32 46.40
5 Carbon Waste 15 0.02 0.40
Total 4380
6 . P r o d u c t : 2-(tert-Butylamino)-1-(3-chlorophenyl) propan-1-one:
Bupropion hydrochloride
Ø A ) R e a c t i o n C h e m i s t ry
STAGE 1 : 2-(tert-Butylamino)-1-(3-chlorophenyl) propan-1-one bupropion hydrochloride
3 Chloro 2 Bromo Propiophenone Bupropion.HCl
MW 247.52 MW 276.20
Cl
OCH3
Br
(CH3)
3CNH
2
Cl
OCH3
NHCH3
CH3CH3
. HCl
Ø B ) P r o c es s F l o w D i a g r am
3-Chloro-2'-Bromo Propiophenone
tert Butyl Amine
Tlouene
Water
Methanolic HCl
Iso Propyl Alcohol
Carbon
S T A G E 1
Solvent Recovery
Evaporation Loss
Process Emissions
Carbon Waste
F I N I S H
P R O D U C T
Ø C ) M a n u f a c t u r i n g P r o c e s s
STAGE 1 : 2-(tert-Butylamino)-1-(3-chlorophenyl) propan-1-one bupropion hydrochloride
• Charged Toluene in Reactor at RT.
• Charge 3-Chloro-2’-Bromo Propiophenone in Toluene
• Slowly charged tert butyl amine in about mass at RT
• Heat Reaction Mass to 55-60oC. Maintain this temp for 3-4 hrs
• Add water in above reaction mass and stir for 1 hrs.
• Now cool the reaction mass and separate the organic layer.
• Charged Carbon in above layer and heat it.
• Filter the above Reaction Mass by Sparkler filter.
• Chilled the filtrate and then Charged Methanolic HCl in Reactor at 5-10oC.
• Maintain RM for 3 hrs at same temp.
• Filter the solid mass.
• Charged Iso Propyl Alcohol in Reactor at RT.
• Add solid mass and stir for 2 hrs.
• Filter the solid mass and dry it
Ø D ) S u m m a ry o f M a s s
Capacity, Mt/Month : 10.00
Batch Size, Kg : 400
Working Days : 26
Sr.
No Name of Raw Material Kg/batch
Kg/Kg of
Product
MT/Mon
th Remarks
Input
1 Toluene 1000 2.50 25.00
2 3-Chloro-2’-Bromo
Propiophenone 400 1.00 10.00
3 tert butyl amine 140 0.35 3.50
4 Water 600 1.50 15.00
5 20% Methanolic HCl 325 0.81 8.13
6 Iso Propyl Alcohol 800 2.00 20.00
7 Carbon 10 0.03 0.25
Total 3275
Output
1 Final Product 400 1.00 10.00 Finished product
2 Toluene (Recd) 955 2.39 23.88 Recycle
3 Isopropyl alcohol (Recd) 770 1.81 18.13 Recycle
4 Distillation + Drying loss 205 0.63 6.25
4 Residue 20 0.06 0.50
5 Effluent 910 2.28 22.80
7 Carbon Waste 15 0.04 0.38
Total 3275
7 . P r o d u c t : 6-Methyl pyridine-3 yl-2,4-Methylsulfonyl phenyl Etanone
(Ketosulfone)
Ø A ) R e a c t i o n C h e m i s t ry
Intermediate Step
MW 282.37
CH3
S
CN
O
N
CH3
Ketosulfone
MW 289.35
H3CO2S
O
N
CH3
4 Methyl Thiophenyl Acetonitrile
MW 163.24
Methyl 6 Methyl Nicotinate
MW 151.16
CH3
S
CN
COOCH3
N
CH3
+
+CH3 OH
Methanol
MW 32.04
MW 18.02
2 H2O
+ + CO2
NH3
O2
Ø B ) P r o c es s F l o w D i a g r am
4 Methyl Thiophenyl Acetonitrile
Methyl 6 Methyl Nicotinate
Sodium Methoxide
Sodium Tungstate
Toluene
Hydrogen Peroxide 48%
Conc Sulfuric Acid
Methanol
Water
S T A G E
Effluent
Process Emissions
Solvent Recovery
Evaporation Loss
F I N I S H
P R O D U C T
Ø C ) M a n u f a c t u r i n g P r o c e s s
• Charged 4 Methyl thiophenyl acetonitrile in toluene in Reactor at RT.
• Charged Sodium Methoxide powder in above reaction mixture slowly at RT
• Charged Methyl 6 methyl nicotinate in RM and was heated and stirred
• Add water in above reaction mass.
• The reaction mixture was heated and stirred. Now cool the reaction mass.
• The separated solid was filtered.
• Charged methanol and above solid in Reactor at RT
• Cool the reaction mass and add Sulfuric Acid and Sodium Tangustate
• Slowly add hydrogen peroxide under stirring with cooling
• Cool the reaction mass and separate the wet cake by filtration. Dry the Product
Ø D ) S u m m a ry o f M a s s
Capacity, Mt/Month : 10.00
Batch Size, Kg : 250
Working Days : 26
Sr.
No Name of Raw Material Kg/batch
Kg/Kg of
Product MT/Month Remarks
Input
1 4 Methyl thiophenyl
acetonitrile 160 0.64 6.40
2 Toluene 240 0.96 9.60
3 Sodium Methoxide 80 0.32 3.20
4 Methyl 6 Methyl Nicotinate 148 0.59 5.90
5 Water 500 2.00 20.00
6 Methanol 150 0.60 6.00
7 Sodium Tangustate 3 0.01 0.10
8 Hydrogen Peroxide 160 0.64 6.40
9 Conc Sulfuric Acid 5 0.02 0.20
Total 1446
Output
1 Finish Product 250 1.00 10.00 Finished product
2 Toluene (Recd) 215 0.86 8.60 Recycle
3 Distillation + Drying Loss 105 0.42 4.20
4 Residue 3 0.01 0.10
5 Effluent 873 3.49 34.90
Total 1446
8 . P r o d u c t : 5 - C h l o r o - 6 ' - m e t h y l - 3 - [ 4 - ( m e t h y l s u l f o n y l ) p h e n y l ] -
2 , 3 ' - b i p y r i d i n e : E t o r i c o x i b
Ø A ) R e a c t i o n C h e m i s t ry
MW 289.35
Ketosulfone
MW 358.84
5-Chloro-6'-methyl-3-[4-(methylsulfonyl)phenyl]-2,3'-bipyridine etoricoxib
O
CH3
S
O
O
N CH3
O
CH3
S
O
N
N CH3
Cl
CH3
N+
N
CH3
CH3
Cl CH3
PF6
-
MW 306.62
CDT Salt
+
Ø B ) P r o c es s F l o w D i a g r am
Ketosulfone
CDT Salt
Potassium tert Butoxide
Acetic Acid
Toluene
DMF
Iso Propyl Alcohol
Carbon
Water
S T A G E
Solvent Recovery
Evaporation Loss
Effluent
Carbon waste
F I N I S H
P R O D U C T
Ø C ) M a n u f a c t u r i n g P r o c e s s
• Charged DMF in Reactor at RT.
• Charged Stage 1 and 2-chloro-1,3-bis(dimethylamino) trimethinium hexaflouro
phosphate salt CDT Salt in above reaction mixture.
• Charged Potassium tert Butoxide in Reactor at RT
• The reaction mixture was heated and stirred.
• Remove excess of solvent by distillation.
• Charge toluene and acetic acid in above reaction mixture
• The reaction mixture was heated and stirred.
• Charge water in above reaction mixture
• Separate organic layer and aqueous layer
• Add carbon in Organic layer and stir and filter under heating
• Cool the organic layer and separate the wet cake by filtration
• The separated solid was charged in IPA. Heat and then coolthe RM.
• Separate the wet cake by filtration. Dry the Product.
Ø D ) S u m m a ry o f M a s s
Capacity, Mt/Month : 10.00
Batch Size, Kg : 200
Working Days : 26
Sr.
No Name of Raw Material Kg/batch
Kg/Kg of
Product MT/Month Remarks
Input
1 Ketosulfone 170 0.85 8.50
2 DMF 500 2.50 25.00
3 CDT Salt 185 0.93 9.30
4 Potassium tert Butoxide 85 0.43 4.30
5 Toluene 400 2.00 20.00
6 Acetic Acid 60 0.30 3.00
7 Water 450 2.25 22.50
8 IPA 300 1.50 15.00
9 Carbon 5 0.03 0.30
Total 2155
Output
1 Finish Product 200 1.00 10.00 Finished product
2 DMF (Recd) 465 2.33 23.30 Recycle
3 Toluene (Recd) 380 1.85 18.50 Recycle
4 IPA (Recd) 285 1.33 13.30 Recycle
5 Distillation + Drying Loss 30 0.30 3.00
6 Residue 17 0.09 0.90
7 Effluent 768 3.84 38.40
8 Waste Carbon 10 0.05 0.50
Total 2155
9. Product : 2-(2-Fluorobiphenyl-4-yl)propanoic acid : Flurbiprofen
Ø A ) R e a c t i o n C h e m i s t ry
Stage 1
+
Diethyl Methyl
Malonate
MW 174.19
NO2
F
F
2,4 Difluoro
Nitrobenzene
MW 159.09
O
O
O
O
CH3
CH3CH3
NH2
F
O
O
O OCH3
CH3
CH3
Stage 1
MW 283.29
NaOH
DMF
Pd/C
Methanol + HF + H2O
MW 20.01
MW 18.01
Stage 2
F
O
O
O OCH3
CH3
CH3
Stage 2
NaNO2
Water
+
Stage 1
MW 283.29
NH2
F
O
O
O OCH3
CH3
CH3
Benzene
MW 78.11 MW 344.37
2,4 Difluoro Nitro Benzene
Diethyl Methyl Malonate
Sodium Hydroxide
Dimethyl Formamide
Methanol
Toluene
Palladium Carbon
Hydrogen
Water
S T A G E 1
Solvent Recovery
Evaporation Loss
Organic Residue
Process Emissions
Effluent
Stage 1
Benzene
Copper Powder
Sodium Nitrile
Conc HCl
Toluene
Water
S T A G E 2
Stage 2
Sodium Hydroxide
Acetic Acid
Conc HCl
Toluene
Carbon
S T A G E 3
Solvent Recovery
Evaporation Loss
Organic Residue
Carbon Waste
Process Emissions
Effluent
F I N I S H
P R O D U C T
Solvent Recovery
Evaporation Loss
Organic Residue
Process Emissions
Effluent
Stage 3
Finish Product
MW 244.26
NaOH
Conc HCl
Acetic Acid
F
O
O
O OCH3
CH3
CH3
Stage 2
MW 344.37
F
O
OHCH3
+ 2 H2O
+ 2 C2H
5OH + CO
2
Ø B ) P r o c es s F l o w D i a g r am
Ø C ) M a n u f a c t u r i n g P r o c e s s
Stage 1
• Charge 2,4-Difluoronitrobenzene in Reactor at RT.
• Charge Diethyl methyl malonate, Sodium Hydroxide and Dimethylformamide in RM at
RT.
• Heat Reaction Mass. Maintain this temp for 3 to 4 hrs.
• Charge Toluene in Reactor. Heat to reflux for 30 min.
• Wash the Toluene layer with water.
• Toluene layer was concentrated under pressure to give Diethyl-3-fluoro-(4-
nitrophenyl) methyl propanedioate.
• Resulting intermediate reduction in presence of Palladium Catalyst and Hydrogen gas,
Methanol as solvent.
• After completion of the reaction catalyst was filtered under nitrogen and Methanol
layer was concentrated under reduced pressure to get Stage-1 Compound.
Stage 2
• Charge Stage 1 in Reactor at RT.
• Charge Sodium Nitrile solution, Conc HCl and copper powder in above reaction mass.
• Chilled the Reaction Mass. Maintain this temp for 1-2 hrs.
• Charge slowly Benzene in above reaction mass under chilling condition.
• Now Charged Toluene in above RM under stirring.
• After completion of the reaction Toluene layer was washed with water and
concentrated under reduced pressure to form Stage-2 Intermediate.
Stage 3
• Charge Stage 2 and Sodium Hydroxide solution in Reactor at RT.
• Heat the Reaction Mass. Maintain this temp for 1-2 hrs.
• After completion of the reaction crude solid was isolated by adding Acetic Acid and
Conc HCl to the reaction mass.
• The crude solid was recrystalized in Toluene and Carbon to obtain Finish Product
Ø D ) S u m m a ry o f M a s s
Capacity, Mt/Month : 10.00
Batch Size, Kg : 400
Working Days : 26
Sr.
No Name of Raw Material Kg/batch
Kg/Kg of
Product MT/Month Remarks
Input
1 2,4-Difluoronitrobenzene 350 0.88 8.75
2 Diethyl methyl malonate 380 0.95 9.50
3 Sodium Hydroxide 315 0.79 7.88
4 Dimethylformamide 390 0.98 9.75
5 Toluene 2150 5.38 53.75
6 Palladium Catalyst 7 0.02 0.18
7 Hydrogen 18 0.05 0.45
8 Methanol 1150 2.88 28.75
9 Water 1850 4.63 46.25
10 Benzene 265 0.66 6.63
11 Copper Powder 58 0.15 1.45
12 Sodium Nitrite 195 0.49 4.88
13 Acetic Acid 180 0.45 4.50
14 Conc HCl 1070 2.68 26.75
15 Carbon 5 0.01 0.13
Total 8383
Output
1 Final Product 400 1.00 10.00 Finished product
2 Toluene 2025 5.06 50.63 Recycle
3 Methanol 1080 2.70 27.00 Recycle
4 Palladium Catalyst 10 0.03 0.25 Recycle
5 Distillation + Drying loss 395 0.99 9.88
6 Residue 40 0.10 1.00
7 Carbon waste 10 0.03 0.25
8 Effluent 4423 11.06 110.60
Total 8383
10. Product : Benzamide 5-chloro-N-[2-[4-[(cyclohexylamino)carbonyl]
amino]sulfonyl]phenyl]ethyl]-2-metoxy : Glibenclamide
Ø A ) R e a c t i o n C h e m i s t ry
Ammonia, Acetone
MW 368.83
CHIC Salt
MW 516.99
NO
Cl
OCH3
O NHSO2NH2
5-Chloro-2-methoxy-N-[2-(4-sulfamoylphenyl)
ethyl]benzamide
+
MW 113.16
Cyclo Hexyl Isocyanate
Cl
OCH3
O NHS
NH
O
OO
NH
. Na
Sodium Hydroxide
Methanol
Benzamide 5-chloro-N-[2-[4-[(cyclohexylamino)
carbonyl]amino]sulfonyl]phenyl]ethyl]-2-metoxy glibenclamide
MW 494.00
Cl
OCH3
O NHS
NH
O
OO
NH
Conc HCl
CHIC Salt
MW 516.99
Cl
OCH3
O NHS
NH
O
OO
NH
. Na
Ø B ) P r o c es s F l o w D i a g r am
Sulfonamide Deri
Ammonia
Cyclo Hexyl Isocyanate
Sodium Hydroxide
Acetone
S T A G E 1
Evaporation Loss
Solvent Recovery
Effluent
Residue
Step 1
Conc HCl
Methanol
Water
S T A G E 2
Evaporation Loss
Solvent Recovery
Residue
Effluent
F I N I S H
P R O D U C T
Ø C ) M a n u f a c t u r i n g P r o c e s s
STAGE 1
• Charge Ammonia, Sodium Hydroxide, Sulfonamide deri and Acetone in Reactor.
• Slowly Charged Cyclohexyl isocyante in Acetone in above solution.
• Heat the reaction mass under stirring for several times.
• After completion of the reaction, Solvent was removed under vacuum to get crude
material
• The solid was treated with water under stirring and heating. Cool the rm and filter the
solid
• The crude solids are washed with chilled methanol.
• Dry the product to give White to off white solid
STAGE 2
• Charge Methanol and step 1 and in Reactor.
• Conc HCl and water solution is slowly charged in above RM. Heat the mass.
• Heat the reaction mass under stirring for several time.
• Cool the reaction mass and filter the solid
• The crude solids are washed with water.
• Dry the product to give White to off white solid
Ø D ) S u m m a ry o f M a s s
Capacity, Mt/Month : 10.00
Batch Size, Kg : 400
Working Days : 26
Sr.
No Name of Raw Material Kg/batch
Kg/Kg of
Product MT/Month Remarks
Input
1 Sulfonamide Deri 325 0.81 8.13
2 Ammonia 500 1.25 12.50
3 Cyclo Hexyl Isocyanate 110 0.28 2.75
4 Acetone 3250 8.13 81.25
5 Sodium Hydroxide 50 0.13 1.25
6 Conc HCl 175 0.44 4.38
7 Carbon 20 0.05 0.50
8 Water 2400 6.00 60.00
Total 6820
Output
1 Final Product 400 1.00 10.00 Finished product
2 Acetone 3090 7.43 74.25 Recycle
3 Residue 50 0.13 1.25
4 Drying + Distillation loss 190 0.73 7.25
5 Effluent 3060 7.70 77.00
6 Carbon waste 30 0.08 0.75
Total 6820
1 1 . D i b en z o [ b , f ] [ 1 , 4 ] Th i a z ep i n - 1 1 ( 10 H ) - O n e
Ø A ) R e a c t i o n C h e m i s t ry
MW 227.28
Ethyl Chloro Formate
MW 108.52
PPA
+ HCl
MW 36.46
MW 201.28
2 Amino Phenyl Phenyl Sulfide
NH2
S
N
H
S
O
Dibenzo[b,f][1,4]Thiazepin-11(10H)-One
+
MW 46.09
C2H5OH
Ø B ) P r o c es s F l o w D i a g r am
2 Amino Phenyl Phenyl Sulfide
Ethyl Chloro formate
Poly Phosphoric Acid
Water
S T A G E
Process Emissions
Evaroparation Loss
Effulent
Phosphoric Acid Solution
F I N I S H
P R O D U C T
Ø C ) M a n u f a c t u r i n g P r o c e s s
• Charged 2 Amino phenyl phenyl sulfide and Ethyl chloro formate in Reactor at RT
• The reaction mixture was heated and stirred well.
• Charged PPA and water in above reaction mass.
• Heat the RM and stir well for several time.
• Separate Organic layer and aqueous layer.
• Charged water in above organic layer and heat under stirring.
• The reaction mixture was cooled.
• The separated solid was filtered wash with water and dried.
Ø D ) S u m m a ry o f M a s s
Capacity, Mt/Month : 10.00
Batch Size, Kg : 400
Working Days : 26
Sr.
No Name of Raw Material Kg/batch
Kg/Kg of
Product MT/Month Remarks
Input
1 2 Amino phenyl phenyl
sulfide 380 0.95 9.50
2 Poly Phosphoric Acid PPA 1200 3.00 30.00
3 Ethyl Chloro formate 250 0.63 6.25
4 Water 1400 3.50 35.00
Total 3230
Output
1 Final Product 400 1.00 10.00 Finished product
2 Drying Loss 130 0.33 3.25
3 Effluent 2700 6.75 67.50
Total 3230
1 2 . 2-[2-(4-dibenzo [b,f] [1,4]thiazepin-11-yl-1-piperazinyl)ethoxy]-ethanol :
Quetiapine fumarate
Ø A ) R e a c t i o n C h e m i s t ry
Thionyl Chloride
Ethanol
Fumaric Acid
+ H2O
MW 18.02
2-[2-(4-dibenzo [b,f] [1,4]thiazepin-11-yl-1-piperazinyl) ethoxy]-ethanol quetiapine fumarate
MW 227.28
N
H
S
O
Dibenzo[b,f][1,4]Thiazepin-11(10H)-One
N
NH
O
OH+
MW 174.24
2-((2-Piperazin-1-yl)ethoxy)ethanol
NN
O
OH
N
S
H
O
OH
O
OH
H
MW 883.02
Ø B ) P r o c es s F l o w D i a g r am
Dibenzo-1,4-thiazepine-11-one
Thionyl Chloride
Toluene
2-(2-(Piperazin-1-yl)ethoxy)ethanol
Ethanol
Fumaric Acid
Acetic Acid
Water
S T A G E
Process Emissions
Evaroparation Loss
Effulent
Solvent Recovery
Organic Residue
F I N I S H
P R O D U C T
Ø C ) M a n u f a c t u r i n g P r o c e s s
• Charged Dibenzo-1,4-thiazepine-11-one and Thionyl chloride in Reactor at RT
• The reaction mixture was heated and stirred well.
• Charged Toluene and water in above reaction mass.
• Cool the RM and stir well for several time.
• Separate Organic layer and aqueous layer.
• Charged Piperazin ethoxy ethanol in above reaction mass and heat for some time.
• Remove excess of Toluene for Organic layer.
• Charged ethanol Acetic Acid and Fumaric Acid in above reaction mass.
• The reaction mixture was heated and stirred well
• Cool the RM and stir well for several time
• The separated solid was filtered wash with water and dried.
Ø D ) S u m m a ry o f M a s s
Capacity, Mt/Month : 10.00
Batch Size, Kg : 400
Working Days : 26
Sr.
No Name of Raw Material Kg/batch
Kg/Kg of
Product MT/Month Remarks
Input
1 Dibenzo-1,4-thiazepine
one 230 0.58 5.75
2 Thionyl chloride 200 0.50 5.00
3 Toluene 1000 2.50 25.00
4 Piperazin ethoxy ethanol 185 0.46 4.63
5 Ethanol 1200 3.00 30.00
6 Fumaric Acid 60 0.15 1.50
7 Acetic Acid 40 0.10 1.00
8 Water 1000 2.50 25.00
Total 3915
Output
1 Final Product 400 1.00 10.00 Finished product
2 Toluene 945 2.36 23.63 Recycle
Ethanol 1130 2.83 28.25 Recycle
3 Distillation + Drying Loss 180 0.45 4.50
6 Effluent 1260 3.15 31.50
Total 3915
1 3 . P r o d u c t : N-{2-[4-(aminosulfonyl)phenyl]ethyl}-3-ethyl-4methyl-
2-oxo-2,5-dihydro-1H-pyrrole-1-carboxamide [Glimepiride Sulphonamide]
Ø A ) R e a c t i o n C h e m i s t ry
3-Ethyl-4-methyl-3-pyrrolin-2-one
MW 125.17
N
CH3CH3
NHO
O
3-Ethyl-4-methyl-2-oxo-N-(2-phenylethyl)
-2,5-dihydro-1H-pyrrole-1-carboxamide
MW 272.34
3-Ethyl-4-methyl-2-oxo-N-(2-phenylethyl)
-2,5-dihydro-1H-pyrrole-1-carboxamide
MW 147.17
N
H
CH3CH3
OOCN
+
Toluene
N
CH3CH3
NHO
O
3-Ethyl-4-methyl-2-oxo-N-(2-phenylethyl)
-2,5-dihydro-1H-pyrrole-1-carboxamide
MW 272.34
N
CH3CH3
NHO
O SO2NH2
N-{2-[4-(Aminosulfonyl)phenyl]ethyl}-3-ethyl-4-
methyl-2-oxo-2,5-dihydro-1H-pyrrole-1-carboxamide
MW 351.42
Chloro Sulfonic Acid
+ +ClSO3H 2 NH3
Liq Ammonia
MW 116.52 MW 17.03
+NH4Cl H2O
MW 53.49 MW 18.02
+
Ø B ) P r o c es s F l o w D i a g r am
3 Ethyl 4 Methyl Pyrrolin
2 Phenyl Ethyl Isocyanate
Toluene
S T A G E 1Solvent Recovery
Evaporation Loss
Organic Residue
Amide deri
Chlorosulfonic acid
Liq Ammonia
Water
EDC
Solvent Recovery
Evaporation Loss
Organic Residue
Effluent
Process Emissions
F I N I S H
P R O D U C T
S T A G E 2
Ø C ) M a n u f a c t u r i n g P r o c e s s
• Charged 3 Ethyl 4 methyl Pyrroline and toluene is SSR.
• Charged slowly 2 Phenyl Isocyante in it.
• Heat the RM to reflux for 2 hrs.
• Cool and then chilled the rm.
• Filter the mass and dry it.
• Charged Chloro Sulfonic Acid in Reactor at RT and chilled it.
• Charged Amide derivative in above reaction mixture in chilling condition.
• The reaction mixture was heated and stirred
• The reaction mixture was very slowly quenched in chilled ammonia solution.
• Filter the solid mass, wash with water and dry it.
• Charged EDC and above crude product in Reactor at RT.
• The reaction mixture was heated and stirred. the chilled to 0-5oC
• Filter the solid mass under chilling condition and dry it.
Ø D ) S u m m a ry o f M a s s
Capacity, Mt/Month : 5.00
Batch Size, Kg : 200
Working Days : 26
Sr.
No Name of Raw Material Kg/batch
Kg/Kg of
Product MT/Month Remarks
Input
1 3 Ethyl methyl Pyrroline 80 0.40 2.00
2 2 Phenyl ethyl isocyanate 80 0.40 2.00
3 Toluene 700 3.50 17.50
4 Chloro Sulfonic Acid 200 1.00 5.00
5 Ammonia Solution 620 3.10 15.50
6 EDC 400 2.00 10.00
7 Water 200 1.00 5.00
Total 2280
Output
1 Final Product 200 1.00 5.00 Finished product
2 Toluene 670 3.35 16.75 Recycle
3 EDC 385 1.70 8.50 Recycle
4 Distillation + Drying loss 165 0.83 4.12
5 Residue 5 0.03 0.13
6 Effluent 875 4.38 21.88
Total 2280
14. P r o d u c t : 3-Ethyl-4-methyl-N-[2-(4-{[(trans-4-methylcyclohexyl)
carbamoyl]sulfamoyl}phenyl)ethyl]-2-oxo-2,5-dihydro-1H-pyrrole-1-
carboxamide : Glimepiride
Ø A ) R e a c t i o n C h e m i s t ry
K2CO3
N
CH3
CH3
NH
O O
S
O
NH
O
O
NH
CH3
3-Ethyl-4-methyl-N-[2-(4-{[(trans-4-methylcyclohexyl)carbamoyl]sulfamoyl}
phenyl)ethyl]-2-oxo-2,5-dihydro-1H-pyrrole-1-carboxamide glimepiride
MW 490.62
N
CH3CH3
NHO
O SO2NH2+
CH3
OCN
N-{2-[4-(aminosulfonyl)phenyl]ethyl}-3-ethyl-4-
methyl-2-oxo-2,5-dihydro-1H-pyrrole-1-carboxamideTrans 4 methyl cyclohexyl isocyanate
MW 351.42 MW 139.19
Ø B ) P r o c es s F l o w D i a g r am
Sulfonamide deri
Trans Isocyanate
Potassium Hydroxide
Acetone
Methanol
Conc HCl
Water
Carbon
Solvent Recovery
Evaporation Loss
Organic Residue
Effluent
Waste Carbon
F I N I S H
P R O D U C T
S T A G E
Ø C ) M a n u f a c t u r i n g P r o c e s s
• Charged Acetone, Potassium Carbonate and Sulfonamide derivative in Reactor at RT.
• Charged Trans 4 methyl cyclo hexyl isocyanate in Reaction Mixture.
• The reaction mixture was heated and stirred
• Cool the reaction mixture and separate the solid mass by filtration.
• Charged methanol, carbon and above wet cake in Reactor.
• The reaction mixture was heated and stirred then filter by sparkler filter
• Charged Conc HCl in Reaction Mixture.
• Filter the solid mass, wash with water and dry it
Ø D ) S u m m a ry o f M a s s
Capacity, Mt/Month : 5.00
Batch Size, Kg : 200
Working Days : 26
Sr.
No Name of Raw Material Kg/batch
Kg/Kg of
Product MT/Month Remarks
Input
1 Sulfonamide Derivative 200 1.00 5.00
2 Trans Iso Cyanate 120 0.60 3.00
3 Acetone 2000 10.00 50.00
4 Potassium Carbonate 150 0.75 3.75
5 Methanol 800 4.00 20.00
6 Conc HCl 325 1.63 8.13
7 Water 200 1.00 5.00
8 Carbon 5 0.25 0.13
Total 3800
Output
1 Final Product 200 1.00 5.00 Finished product
2 Acetone 1900 9.50 47.50 Recycle
3 Methanol 775 3.50 17.50
4 Distillation + Drying loss 75 0.75 3.75
5 Residue 15 0.08 0.40
6 Effluent 825 4.12 20.60
7 Carbon 10 0.05 0.25
Total 3800
15. Product : m-Hydroxy-alpha-(methylaminomethyl) benzyl alcohol : Phenyl
ephrine hydrochloride
Ø A ) R e a c t i o n C h e m i s t ry
Stage 1
OH
O CH2Br
OH
O CH3
MW 136.15 MW 215.04
3'-Hydroxy Acetophenone 2-Bromo-3'-Hydroxy Acetophenone
Br2
+ HBr
Stage 2
OH
O
N
CH3
OH
O CH2Br
NHCH3
MW 255.31
MW 121.17
2-Bromo-3'-Hydroxy Acetophenone1-(3-Hydroxyphenyl)-2-[Methyl
(Phenylmethyl)amino]ethanone
MW 215.04
+ HBr
Stage 3
OH
ON
CH3
OH
OHNH
CH3
MW 167.21MW 255.31
1-(3-Hydroxyphenyl)-2-[Methyl
(Phenylmethyl)amino]ethanoneDL Phenyl Ephrine
Hydrogen
CH3
+
MW 92.14
Toluene
Stage 4
OH
OHNH
CH3
OH
NH
CH3
OH
H
MW 167.21
DL Compound
Methanolic HCl
L Tartaric Acid
MW 203.66
Finish Product
. HCl
Ø B ) P r o c es s F l o w D i a g r am
m Hydroxy Acetophenone
Ethyl Acetate
Water
Bromine
Toluene
S T A G E 1Process Emissions
Effluent
Stage 1
Toluene
n Methyl Benzyl Amine
IPA.HCl
S T A G E 2
Stage 3
L Tartaric Acid
Iso Propyl Alcohol
Liq Ammonia
Acetic Anhydride
Sulfuric Acid
Water
Methanol
Carbon
Methanolic HCl
S T A G E 4
Solvent Recovery
Evaporation Loss
Process Emissions
Effluent
Carbon waste
F I N I S H
P R O D U C T
Solvent Recovery
Evaporation Loss
Organic Residue
Process Emissions
Effluent
Stage 2
Methanol
Pd/C
Liq Ammonia
Water
S T A G E 3
Solvent Recovery
Evaporation Loss
Pd/C
Effluent
Ø C ) M a n u f a c t u r i n g P r o c e s s
Stage 1
• Charge Ethyl Acetate and m Hydoxy Acetophenone in Reactor at RT. Cool the RM
• Slowly charge Liq Bromine in RM under starring and cooling.
• Maintain this temp for 3 to 4 hrs.
• Charge Toluene in Reactor.
• Wash the Toluene layer with water.
• Toluene layer was concentrated under pressure to Crude stage 1.
Stage 2
• Charge Stage 1 and Toluene in Reactor at RT. Now cool the RM.
• Charge n methyl benzyl amine in above reaction mass.
• Chilled the Reaction Mass. Maintain this temp for 1-2 hrs.
• Filter the RM. Separate the wet cake for N methyl benzyl amine recovery.
• Charge slowly IPA.HCl above filtration mass under chilling condition.
• After completion of the reaction separate Stage-2 Intermediate by filtration.
• Wash the product with chilled Toluene.
• Dry the product for next stage reaction.
Stage 3
• Charge Stage 2, Methanol and Palladium carbon in Pressure Reactor at RT.
• Heat the Reaction Mass. Maintain this temp for 4-5 hrs under pressure.
• Cool the RM and filter the mass to separate used Pd/C.
• Remove excess of Methanol under reduced pressure. Add water in RM.
• Crude solid was isolated by adding liq Ammonia in the reaction mass.
• Dry the product for next stage reaction
Stage 4
• Charge Stage 3, IPA and L Tartaric Acid Reactor at RT.
• Charge water in above RM and heat the Reaction Mass. Maintain this temp for 6-8 hrs.
• Cool the RM and filter the Mass - D Salt.
• Take filtrate and adjusted pH to with Liq Ammonia.
• Crude solid A was wash with water and dry it.
• Take D Salt in water and heat it to get clear solution.
• Crude solid was isolated by adding liq Ammonia in the reaction mass
• Dry the product for next stage reaction
• Take Acetic Anhydride and above dry product in reactor and slowly add sulfuric acid.
• Heat the Reaction Mass. Maintain this temp for 8-10 hrs
• Cool the reaction mass and add Liq Ammonia slowly at RT.
• Filter the Solid mass B and dry it.
• Charged Methanol in reactor and add Solid mass A and B. Heat the mass to get clear
solution.
• Give carbon treatment the above solution.
• Charges slowly Methanolic HCl in above filtrate and cool the reaction mass.
• Filter the solid product, wash with chilled Methanol and dry it.
Ø D ) S u m m a ry o f M a s s
Capacity, Mt/Month : 5.00
Batch Size, Kg : 200
Working Days : 26
Sr.
No Name of Raw Material Kg/batch
Kg/Kg of
Product MT/Month Remarks
Input
1 m Hydroxy Acetophenone 225 1.13 5.63
2 Ethyl Acetate 330 1.65 8.25
3 Bromine 280 1.40 7.00
4 Toluene 1130 5.65 28.25
5 Water 1065 5.33 26.63
6 N Methyl benzyl Amine 365 1.83 9.13
7 IPA.HCl 210 1.05 5.25
8 Palladium carbon 8 0.04 0.20
9 Methanol 670 3.35 16.75
10 Liq Ammonia 460 2.30 11.50
11 L Tartaric Acid 226 1.13 5.65
12 IPA 465 2.33 11.63
13 Acetic Anhydride 220 1.10 5.50
14 Sulfuric Acid 47 0.24 1.18
15 Methanolic HCl 200 1.00 5.00
16 Carbon 5 0.03 0.13
Total 5906
Output
1 Final Product 200 1.00 5.00 Finished product
2 Ethyl Acetate 280 1.40 7.00 Recycle
3 Toluene 1090 5.20 26.00 Recycle
4 Methanol 650 3.75 18.75 Recycle
5 N Methyl benzyl Amine 160 0.80 4.00 Recycle
7 Residue 20 0.10 0.50
8 Distillation + Drying loss 620 2.85 14.25
9 Effluent 2861 14.31 71.53
10 Carbon waste 10 0.05 0.25
11 Pd/C 15 0.08 0.38 Recycle
Total 5906
16. Product : 3-ethyl 5-methyl 2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-
6-methyl-1,4-dihydropyridine-3,5-dicarboxylate : Amlodipine besylate
Ø A ) R e a c t i o n C h e m i s t ry
Mono Methyl Amine
4-(2-Chlorophenyl)-3-ethoxycarbonyl-5-methoxy
carbonyl-6-methyl-2-(phthalimidoethoxy)
methyl-1,4-dihydropyridine (Phthaloyl Amlodipine)
MW 538.98
N
H
CH3
H3COOC COOC2H5
Cl
ON
O
O
MW 31.05
3-ethyl 5-methyl 2-[(2-aminoethoxy)
methyl]-4-(2-chlorophenyl)-6-methyl-1,4-dihydro
pyridine-3,5-dicarboxylate
MW 408.87
N
H
CH3
H3COOC COOC2H5
Cl
ONH2
HCH3 N
O
O
+
2 Methyl-1-isoindole-1,3-dione
MW 161.16
3-ethyl 5-methyl 2-[(2-aminoethoxy)
methyl]-4-(2-chlorophenyl)-6-methyl-1,4-dihydro
pyridine-3,5-dicarboxylate amlodipine Besylate
N
H
CH3
H3COOC COOC2H5
Cl
ONH2
H
3-ethyl 5-methyl 2-[(2-aminoethoxy)
methyl]-4-(2-chlorophenyl)-6-methyl-1,4-dihydro
pyridine-3,5-dicarboxylate
MW 408.87
N
H
CH3
H3COOC COOC2H5
Cl
ONH2
H+
Benzene Sulfonic Acid
MW 158.17
SO3H
SO3H
.
MW 567.05
Ø B ) P r o c es s F l o w D i a g r am
S T A G E 1
Evaporation Loss
Solvent Recovery
Effluent
Residue
Step 1
Benzene Sulfonic Acid
Ethyl Acetate
MethanolS T A G E 2
Evaporation Loss
Solvent Recovery
Residue
F I N I S H
P R O D U C T
Phthaloyl Amlodipine
Mono Methyl Amine
Methanol
Water
Ø C ) M a n u f a c t u r i n g P r o c e s s
STAGE 1
• Charge Methanol, Phthaloyl Amlodipine and Mono Methyl amine in Reactor.
• Heat the reaction mass under stirring for several times.
• After completion of the reaction, Solvent was removed under vacuum to get crude
material
• The solid was treated with water under stirring and heating. Cool the rm and filter the
solid
• The crude solids are washed with water.
• Dry the product to give White to off white solid
STAGE 2
• Charge Ethyl acetate and step 1 and in Reactor.
• Charge Benzene Sulfonic acid solution in ethyl acetate in above RM. Heat the mass.
• Heat the reaction mass under stirring for several time.
• After completion of the reaction, Solvent was removed under vacuum to get crude
material
• The solid was treated with methanol under stirring and heating. Cool the rm and filter
the solid
• The crude solids are washed with methanol.
• Dry the product to give White to off white solid
Ø D ) S u m m a ry o f M a s s
Capacity, Mt/Month : 05.00
Batch Size, Kg : 400
Working Days : 26
Sr.
No Name of Raw Material Kg/batch
Kg/Kg of
Product MT/Month Remarks
Input
1 Phthaloyl Amlodipine 435 1.09 5.44
2 Mono Methyl Amine 670 1.68 8.38
3 Methanol 1750 4.38 21.88
4 Ethyl Acetate 1235 3.09 15.44
5 Benzene Sulfonic Acid 150 0.38 1.88
6 Carbon 30 0.75 0.38
7 Water 3520 8.80 44.00
Total 7790
Output
1 Final Product 400 1.00 5.00 Finished product
2 Methanol 1670 4.18 20.88 Recycle
3 Ethyl Acetate 1190 2.80 14.00 Recycle
4 Residue 45 0.11 0.56
5 Drying + Distillation loss 160 0.58 2.88
6 Effluent 4270 10.68 53.38
7 Carbon waste 55 0.14 0.69
Total 7790
1 7 . P r o d u c t : 1 0 , 1 1 - d i h y d r o - 10 - o x o - 5 H - d i b e n z ( b , f ) a z e p i n e
- 5 - c a r b o x a m i d e : O x c a rb a z a p i n e
Ø A ) R e a c t i o n C h e m i s t ry
STAGE 1 : 10,11-dihydro- 10-oxo- 5H-dibenz(b,f)azepine-
5-carboxamide oxcarbazapine
MW 223.27
10-Metoxy-5H-di benz(b,f)azepin
NaOCN+
+ NaCl
MW 65.01
MW 58.44
N
H
O
CH3
N
O
ONH2
+ H2O
MW 18.02
+ HCl
MW 36.46
MW 252.26
10,11-dihydro- 10-oxo- 5H-dibenz(b,f) azepine- 5-carboxamide oxcarbazepine
+ CH3OH
MW 32.04
Ø B ) P r o c es s F l o w D i a g r am
Toluene
10-Metoxy-5H-di benz(b,f)azepine
Sodium Cyanate
Acetic Acid
Water
Conc HCl
S T A G E
1Efflulent
F I N I S H
P R O D U C T
Stage 1
Methanol
Carbon
S T A G E
2
Evoparation Loss
Residue
Carbon
Ø C ) M a n u f a c t u r i n g P r o c e s s
STAGE 1 : 10,11-dihydro- 10-oxo- 5H-dibenz(b,f)azepine-
5-carboxamide oxcarbazapine Crude
• Charged Toluene, 10-Metoxy-5H-di benz(b,f)azepine and sodium cynate in Reactor at
RT.
• Charged acetic acid in above reaction mixture and Stir it
• The reaction mixture was heated and stirred. Add water in above Reaction Mass.
• Allow settling and separating it. Discard aqueous layer
• Hydrochloric acid was added to the reaction mixture and then heated
• The reaction mixture was cooled.
• The separated solid was filtered and wash with water and dried.
STAGE 2 : 10,11-dihydro- 10-oxo- 5H-dibenz(b,f)azepine-
5-carboxamide oxcarbazapine
• Charged Methanol and Stage 1 in Reactor at RT.
• The reaction mixture was heated and stirred.
• Add Carbon in above mixture and further heated under stirring.
• Filter the reaction mass in hot condition.
• The reaction mixture was cooled.
• The separated solid was filtered and dried.
Ø D ) S u m m a ry o f M a s s
STAGE 1 : 10,11-dihydro- 10-oxo- 5H-dibenz(b,f)azepine-
5-carboxamide oxcarbazapine
Capacity, Mt/Month : 30.00
Batch Size, Kg : 500
Working Days : 26
Sr.
No Name of Raw Material Kg/batch
Kg/Kg of
Product MT/Month Remarks
Input
1 10-Methoxy
benz(b,f)azepine 470 0.94 28.20
2 Sodium cynate 150 0.30 9.00
3 Toluene 1100 2.20 66.00
4 Acetic acid 60 0.12 3.60
5 Water 550 1.10 33.00
6 Conc HCl 240 0.48 14.40
7 Methanol 1000 2.00 60.00
8 Carbon 5 0.01 0.30
Total 3575
Output
1 Finished Product 500 1.00 30.00 Finished product
2 Toluene (Recd) 1070 2.14 64.20 Recycle
3 Methanol 950 1.90 57.00 Recycle
4 Distillation + Drying loss 145 0.27 8.10
5 Residue 30 0.06 1.80
6 Effluent 870 1.74 52.20
7 Carbon 10 0.02 0.60
Total 3575
18. Product: 2, 3-Dibenzoyl-D-tartaric acid (DBDT)
Ø A ) R e a c t i o n C h e m i s t ry
+
Toluene
O
OH
OHO
OH
OH
D Tartaric Acid
MW 150.09
O Cl
Benzoyl Chloride
MW 127.55
2,3 Dibenzoyl D Tartaric Acid
MW 302.28
O
O
OHO
O
OH
+ HCl
Ø B ) P r o c es s F l o w D i a g r am
Benzoyl Chloride
D Tartaric Acid
TolueneS T A G E
Evaporation Loss
Residue
Distillation Loss
Process Emission
F I N I S H
P R O D U C T
Ø C ) M a n u f a c t u r i n g P r o c e s s
• Charge benzoyl chloride in GLR at RT.
• Charge D-(-)-tartaric acid in RM at RT.
• Heat Reaction Mass. Maintain this temp for 3 to 4 hrs.
• Charge Toluene in Reactor. Heat to reflux for 30 min.
• Cool RM to RT.
• Filter the RM and wash with Chilled toluene.
• Dry the product.
Ø D ) S u m m a ry o f M a s s
Capacity, Mt/Month : 30.00
Batch Size, Kg : 600
Working Days : 26
Sr.
No Name of Raw Material Kg/batch
Kg/Kg of
Product MT/Month Remarks
Input
1 Benzoyl Chloride 535 0.89 26.75
2 D Tartaric Acid 315 0.53 15.75
3 Toluene 900 1.50 45.00
Total 1750
Output
1 Final Product 600 1.00 30.00 Finished product
2 Toluene 875 1.40 42.00 Recycle
3 Distillation + Drying loss 265 0.50 15.00
4 Residue 10 0.02 0.50
Total 1750
19. P ro d u c t : p An i s i c A l c o h o l
Ø A ) R e a c t i o n C h e m i s t ry
MW 136.15
4 Methoxy Benzaldehyde
Hydrogen Gas
Nickel Catalyst
CHO
OCH3
MW 138.17
4 Methoxy Benzyl Alcohol
CH2OH
OCH3
Ø B ) P r o c es s F l o w D i a g r am
REACTOR Nickel Catalyst
F I N I S H
P R O D U C T
4 Methoxy Benzaldehyde
Nitrogen
Nickel Catalyst
Hydrogen
Ø C ) M a n u f a c t u r i n g P r o c e s s
• Take 4 Methoxy Benzaldehyde in an autoclave.
• Then add Nickel (Ni) Catalyst in an autoclave.
• Then parching N2 gas in autoclave to removing O2 in autoclave.
• After passed Hydrogen for 10 to 12 hr.
• That time pressure is 7 to 7.5 Kg. Now checked conversion.
• When conversion is completed than filter of 4 Methoxy Benzyl Alcohol.
Ø D ) S u m m a ry o f M a s s
Capacity, Mt/Month : 30.00
Batch Size, Kg : 1000
Working Days : 26
Sr.
No Name of Raw Material Kg/batch
Kg/Kg of
Product MT/Month Remarks
Input
1 4 Methoxy Benzaldehyde 1000 0.998 29.94
2 Nickel Catalyst 5 0.005 0.15
3 Hydrogen gas 270 M3 0.268 M
3 8040 M
3
4 Nitrogen 20 M3 0.019 M
3 597 M
3
Total 1019
Output
1 Final Product 1007 1.000 30.00 Finished product
3 Filter Loss 1 0.003 0.09
4 Nickel Catalyst 11 0.010 0.30 Regenerated
Total 1019
20. Product : 2-Chloro-1,3-bis(dimentylamino) trimethinium
hexafluorophosphate [CDT Salt]
Ø A ) R e a c t i o n C h e m i s t ry
+
POCl3
NaOH
HPF6
CH3
O
N H
CH3
Dimethyl Formamide
MW 93.09
N
ClCH3
CH3
N+
CH3
CH3PF6
-
2-Chloro-1,3-bis(dimethylamino)
triethinium hexafluoro phosphate Salt
MW 306.62
Cl
O
Cl
Chloro Acetyl Chloride
MW 112.94
Ø B ) P r o c es s F l o w D i a g r am
Dimethyl Formamide
Chloroacetyl Chloride
Phosphorus Oxychloride
Hexa Fluoro Phosphoric Acid
Caustic Lye
Water
S T A G EEvaporation Loss
Effluent
F I N I S H
P R O D U C T
Ø C ) M a n u f a c t u r i n g P r o c e s s
• Charge Dimethylformamide, Chloroacetyl chloride and in above GLR.
• Charge Phosphorus Oxychloride) in above RM.
• RM is then heated to give a clear yellow solution
• After completion of the addition, the reaction mixture is cooled.
• Charged chilled Caustic solution and hexafluorophosphoric acid solution in water in
RM
• The RM is maintained at same temp for 2 hr, then the solids are collected by
Centrifuged.
• The crude solids are washed with water
• The light-yellow solids are collected by filtration, washed with cold water
• Dry the product to give 2-chloro-1,3-bis(dimethylamino) trimethinium
hexafluorophosphate (CDT Salt) as a light-yellow solid
Ø D ) S u m m a ry o f M a s s
Capacity, Mt/Month : 30.00
Batch Size, Kg : 300
Working Days : 26
Sr.
No Name of Raw Material Kg/batch
Kg/Kg of
Product MT/Month Remarks
Input
1 Dimethylformamide 107 0.36 10.70
2 Chloroacetyl chloride 120 0.40 12.00
3 Phosphorus Oxychloride 165 0.55 16.50
4 Water 250 0.83 25.00
5 Caustic Flakes 200 0.67 20.00
6 hexafluorophosphoric acid 270 0.90 27.00
Total 1112
Output
1 Final Product 300 1.00 30.00 Finished product
2 Drying loss 77 0.26 7.70
3 Effluent 735 2.45 73.50
Total 1312
2 1 . P r o d u c t : 5-Bromo-N-(4,5-dihydro-1H-imidazol-2-yl) quinoxalin-6-
amine : Brimonidine tartrate
Ø A ) R e a c t i o n C h e m i s t ry
STAGE 1 : 5-Bromo-N-(4,5-dihydro-1H-imidazol-2-yl) quinoxalin-6-amine brimonidine
Br
N
NN
S
MW 266.12
Stage 1 Compound
MW 292.13
Stage 1
Br
N
NNH
NH N
NH2
NH2
MW 60.10
Ethylene Diamine
+ + SH2
MW 34.08
STAGE 2 : Purification of STAGE 1
MW 292.13
Stage 1
Br
N
NNH
NH N
MW 292.13
Stage 1
Br
N
NNH
NH N
Crude Pure
STAGE 3 : 5-Bromo-N-(4,5-dihydro-1H-imidazol-2-yl) quinoxalin-6-amine brimonidine
Tartrate
MW 442.22
5-Bromo-N-(4,5-dihydro-1H-imidazol-2-yl)
quinoxalin-6-amine brimonidine tartrate
MW 292.13
Stage 1
Br
N
NNH
NH N
OHO
OH O
OHOH
MW 150.09
L Tartaric Acid
+
Br
N
NNH
NH N
OHO
OH O
OHOH
.
Ø B ) P r o c es s F l o w D i a g r am
Chloro Benzene
5 Bromo 6 Thio ureidoquinoxaline
Ethylene Diamine
Iso Propyl Alcohol
S T A G E 1
Solvent Recovery
Evaporation Loss
Organic Residue
Process Emissions
Stage 1
Sodium Hydroxide (20%)
Hydroxhloride Acid (20%)
Water
S T A G E 2 Effluent
Stage 2
Methanol
L Tartaric Acid
Carbon
S T A G E 3
Solvent Recovery
Evaporation Loss
Organic Residue
Carbon
F I N I S H
P R O D U C T
Ø C ) M a n u f a c t u r i n g P r o c e s s
STAGE 1 : 5-Bromo-N-(4,5-dihydro-1H-imidazol-2-yl) quinoxalin-6-amine brimonidine
• Charged Chorobenzene in Reactor at RT.
• Charge 5-Bromo-6-thiouredo quinoxaline in Chlorobenzene
• Slowly charged a mixture of Chlorobenzene and Ethylene diamine in about mass at RT
• Heat Reaction Mass to 85-90oC. Maintain this temp for 20-22 hrs
• Remove excess of solvent under vacuum.
• Now cool the reaction mass and add Isopropyl alcohol in mass.
• Maintain same temp for 4 hrs.
• Filter the solid mass.
STAGE 2 : Pure from Crude
• Charged 20% HCl in Reactor at RT.
• Charge 5-Bromo-6-thiouredo quinoxaline Crude in above mass
• Slowly charged 20% Caustic lye in above mass at RT. Stir mass for 1 hrs
• Now cool the reaction mass.
• Maintain same temp for 1 hrs.
• Filter the solid mass.
• Wash the Mass with water till pH 6-7
STAGE 3 : 5-Bromo-N-(4,5-dihydro-1H-imidazol-2-yl) quinoxalin-6-amine brimonidine
tartrate
• Charged Methanol in Reactor at RT.
• Charge 5-Bromo-6-thiouredo quinoxaline pure and L tartaric acid and carbon in above
mass
• Slowly heat above mass to reflux. Stir mass for 4 hrs at reflux and filter in hot condition
• Now cool the reaction mass. Then chilled the mass
• Maintain same temp for 1 hrs.
• Filter the solid mass.
• Dry the material.
Ø D ) S u m m a ry o f M a s s
Capacity, Mt/Month : 10.00
Batch Size, Kg : 100
Working Days : 26
Sr.
No Name of Raw Material Kg/batch
Kg/Kg of
Product MT/Month Remarks
Input
1 Chorobenzene 800 8.00 80.00
2 5-Bromo-6-thiouredo
quinoxaline 80 0.80 8.00
3 Ethylene diamine 50 0.50 5.00
4 Isopropyl alcohol 200 2.00 20.00
5 20% HCl 400 4.00 40.00
6 20% Caustic Lye dilute 800 8.00 80.00
7 Methanol 900 9.00 90.00
8 L Tartaric Acid 55 0.55 5.50
9 Water 500 5.00 50.00
10 Carbon 10 0.10 1.00
Total 3795
Output
1 Final Product 100 1.00 10.00 Finished product
2 Chorobenzene (Recd) 770 7.70 77.00 Recycle
3 Isopropyl alcohol (Recd) 180 1.80 18.00 Recycle
4 Methanol (Recd) 865 8.30 83.00 Recycle
5 Distillation + Drying loss 155 1.80 18.00
6 Effluent 1710 17.10 171.00
7 Residue 10 0.10 1.00
8 Waste Carbon 15 0.15 1.50
Total 3795
2 2 . P r o d u c t : ( S ) - N - { ( 3 , 4 - D i m e t h o x y b e n z o c y c l o b u t - 1- y l ) } - N -
( m e t h y l ) ] - N- ( m e t h y l ) a m i n e : I v a b ra d i n e
Ø A ) R e a c t i o n C h e m i s t ry
STAGE 1 : (S)-N-{(3, 4-Dimethoxybenzocyclobut-1-yl)}-N-(methyl)]-N-(methyl)
amine Ivabradine Crude
MW 466.57
Intermediate Step
NO
OO
I
CH3CH3
MW 387.21
IDDB
+
OO
NH
CH3
CH3CH3
.HCl
MW 243.72
MBC.HCl
N
O O
O
CH3
CH3
O
O
NCH3
CH3
CH3
MW 468.59
DBMMA Crude
N
O O
O
CH3
CH3
O
O
NCH3
CH3
CH3
K2CO
3
H2O HIKCl + ++CO
2+
H2
STAGE 1 : Crude to Pure
MW 468.59
DBMMA Crude
N
O O
O
CH3
CH3
O
O
NCH3
CH3
CH3
MW 468.59
DBMMA Pure
N
O O
O
CH3
CH3
O
O
NCH3
CH3
CH3
Ø B ) P r o c es s F l o w D i a g r am
Acetone
Potassium carbonate
IDDB & MBC.HCl
Toluene
Water
IPA
Palladium Carbon
Conc HCl
S T A G E
1
Efflulent
Process Emissions
Solvent Recovery
Evaporation Loss
Crude Product
Methanol
Carbon
S T A G E
2
Solvent Recovery
Evaporation Loss
Waste Carbon
F I N I S H
P R O D U C T
Ø C ) M a n u f a c t u r i n g P r o c e s s
STAGE 1 : (S)-N-{(3, 4-Dimethoxybenzocyclobut-1-yl)}-N-(methyl)]-N-(methyl)
amine Ivabradine Crude
• Charged Potassium carbonate and Acetone in Reactor at RT.
• Charged 3-(3-Iodopropyl)-7,8-dimethoxy-1,3-dihydro-2H-3-benzazepin-2-one (IDDB) in
above reaction mixture
• Charged Slowly 1-[(7S)-3,4-Dimethoxybicyclo[4.2.0]octa-1,3,5-trien-7-yl]-
Nmethylmethanamine hydrochloride (MBC.HCl) in above reaction mixture
• The reaction mixture was heated and stirred.
• After completion of reaction, Acetone was distilled out to obtain thick slurry
• Charged water and Toluene. Separate both layers.
• Removed Toluene from reaction mass by distillation.
• The obtained syrup subjected for reduction reaction in autoclave by using Palladium
on Carbon in IPA at elevated temperature under hydrogen pressure
• Filter the mass and add Water and Conc HCl in above reaction mass.
• The reaction mixture was heated and stirred.
• Cool and then Chilled the reaction mixture
• Filter the solid mass and dry it.
STAGE 2 : (S)-N-{(3, 4-Dimethoxybenzocyclobut-1-yl)}-N-(methyl)]-N-(methyl)
amine Ivabradine Pure
• Charged Methanol in Reactor at RT.
• Charged Crude and carbon in above reaction mixture
• The reaction mixture was heated and stirred and filter in hot condition.
• Cool and then Chilled the reaction mixture
• Filter the solid mass and dry it.
Ø D ) S u m m a ry o f M a s s
Capacity, Mt/Month : 10.00
Batch Size, Kg : 50
Working Days : 26
Sr.
No Name of Raw Material Kg/batch
Kg/Kg of
Product MT/Month Remarks
Input
1 Potassium Carbonate 12 0.24 2.40
2 Acetone 100 2.00 20.00
3 IDDB 45 0.90 9.00
4 MBC.HCl 30 0.60 6.00
5 Water 450 9.00 90.00
6 Toluene 150 3.00 30.00
7 Palladium on Carbon 4 0.08 0.80
8 IPA 60 1.20 12.00
9 Conc HCl 75 1.50 15.00
10 Methanol 300 6.00 60.00
11 Carbon 5 0.10 1.00
Total 1231
Output
1 Finish Product 50 1.00 10.00 Finished product
2 Acetone (Recd) 90 1.80 18.00 Recycle
3 Toluene (Recd) 140 2.80 28.00 Recycle
4 Methanol (Recd) 285 5.50 55.00 Recycle
5 Palladium on Carbon 7 0.14 1.40 Recycle
6 Distillation + Drying Loss 22 0.64 6.40
7 Effluent 628 12.56 125.60
8 Residue 2 0.04 0.40
9 Waste Carbon 7 0.14 1.40
Total 1231
23. P r o d u c t : 3-Trifluoromethyl Cinnamic Acid
Ø A ) R e a c t i o n C h e m i s t ry
MW 208.57
Intermediate Step
NH2
F3C
MW 161.12
3 Trifluoro methyl Aniline
NaNO2+ + 2 HCl
MW 68.99MW 36.46
2 H2O+ + NaCl
MW 18.02
MW 58.44
N+
N
F3C
Cl-
MW 216.16
3 Trifluoromethyl Cinnamic Acid
+
O OH
F3C
+
MW 53.06
H2O
MW 18.02
+
NaCl
MW 58.44
N2 +
MW 28.01
CH2 CN
NaOH
MW 39.99
+
+NH3
MW 17.03
Ø B ) P r o c es s F l o w D i a g r am
3 Trifluoomethyl Aniline
Sodium Nitrile
Conc HCl
Water
Acrylonitrile
Caustic Flakes
Conc Sulfuric Acid
S T A G E Effluent
Process Emissions
F I N I S H
P R O D U C T
Ø C ) M a n u f a c t u r i n g P r o c e s s
• Charged Hydrochloric acid, Water and 3 Trifluoromethyl Aniline in Reactor at RT.
• Charged aqueous Sodium Nitrite in above reaction mixture at RT
• Charged slowly Acrylonitrile in above reaction mixture.
• Add Caustic flakes and water in above reaction mass.
• The reaction mixture was heated and stirred. Now cool the reaction mass.
• Dilute Sulfuric Acid was added to the reaction mixture
• The reaction mixture was cooled.
• The separated solid was filtered and dried.
Ø D ) S u m m a ry o f M a s s
Capacity, Mt/Month : 10.00
Batch Size, Kg : 200
Working Days : 26
Sr.
No Name of Raw Material Kg/batch
Kg/Kg of
Product MT/Month Remarks
Input
1 3 Trifluoromethyl Aniline 160 0.80 8.00
2 Conc HCl 265 1.33 13.30
3 Sodium Nitrite 80 0.40 4.00
4 Acrylonitrile 58 0.29 2.90
5 Water 200 1.00 10.00
6 Caustic Flakes 50 0.25 2.50
7 Conc Sulfuric Acid 70 0.35 3.50
Total 883
Output
1 Finish Product 200 1.00 10.00 Finished product
2 Drying Loss 50 0.25 2.50
3 Effluent 633 3.17 31.70
Total 883
2 4 . P r o d u c t : ((R)-N-[1-(1-naphthyl)ethyl]-3-[3-(trifluoromethyl)
phenyl]propan-1-amine : Cinacalcet hydrochloride
Ø A ) R e a c t i o n C h e m i s t ry
STAGE 1 : Intermediate Stage
MW 216.16
3 Trifluoromethyl Cinnamic Acid
MW 171.24
NH2 CH3
+
MW 371.39
Intermediate Stage
O
NHF3C
CH3
O
OHF3C
+OH2
MW 18.01
H2
+
Naphthyl Ethyl Amine
STAGE 2 : ((R)-N-[1-(1-naphthyl)ethyl]-3-[3-(trifluoromethyl)phenyl]propan-
1-amine cinacalcet hydrochloride
MW 393.87
((R)-N-[1-(1-naphthyl)ethyl]-3-[3-(trifluoromethyl)
phenyl]propan-1-amine cinacalcet hydrochloride
NHF3C
CH3
+NaBO2
MW 65.80
NaBH4
MW 371.39
Intermediate Stage
O
NHF3C
CH3
ClH
HCl
Ø B ) P r o c es s F l o w D i a g r am
Trifluoro Methyl Cinnamic Acid
Raney Nickel
Hydrogen
Methanol
Naphthyl Ethyl Amine
Toluene
Boric Acid
Water
S T A G E
1
Solvent Recovery
Evaporation Loss
Effluent
F I N I S H
P R O D U C T
Stage 1
Sodium Borohydride
MDC
Methanol
Conc HCl
Water
Carbon
S T A G E
2
Solvent Recovery
Evaporation Loss
Effluent
Carbon Waste
Ø C ) M a n u f a c t u r i n g P r o c e s s
STAGE 1 : Intermediate Stage
• Charged Methanol and 3 Trifluoro methyl cinnamic acid in Reactor at RT.
• Charged Raney Nickel in above reaction mixture
• Pass Hydrogen gas in above reaction mixture under pressure
• The reaction mixture was heated and stirred and then filter.
• Remove excess of solvent by distillation from filtrate.
• Charge toluene, Boric Acid and Naphthyl ethyl amine in above reaction mixture
• The reaction mixture was heated and stirred.
• The reaction mixture was cooled.
• The separated solid was filtered and dried.
STAGE 2 : ((R)-N-[1-(1-naphthyl)ethyl]-3-[3-(trifluoromethyl)phenyl]propan-
1-amine cinacalcet hydrochloride
• Charged Methanol in Reactor at RT.
• Charged Stage 1 and Sodium Borohydride in above reaction mixture
• The reaction mixture was heated and stirred.
• Remove excess of solvent by distillation from Reaction Mass.
• Charge MDC and Conc HCl in above reaction mixture
• The reaction mixture was heated and stirred.
• After completion of reaction, charged water in RM and stir it.
• Separate the organic layer and aqueous layer.
• Add carbon in aqueous layer and stir at RT. Filter it by Sparkler.
• Chilled the aqueous layer.
• The separated solid was filtered and dried
Ø D ) S u m m a ry o f M a s s
Capacity, Mt/Month : 10.00
Batch Size, Kg : 200
Working Days : 26
Sr.
No Name of Raw Material Kg/batch
Kg/Kg of
Product MT/Month Remarks
Input
1 Trifluoro methyl Cinnamic
acid 150 0.75 7.50
2 Methanol 600 3.00 30.00
3 Raney Nickel 25 0.13 1.30
4 Toluene 300 1.50 15.00
5 Boric Acid 5 0.03 0.30
6 Naphthyl ethyl amine 115 0.58 5.80
7 Sodium Borohydride 35 0.18 1.80
8 MDC 150 0.75 7.50
9 Conc HCl 250 1.25 12.50
10 Water 600 3.00 30.00
11 Carbon 15 0.08 0.80
Total 2245
Output
1 Finish Product 200 1.00 10.00 Finished product
2 Methanol (Recd) 580 2.65 26.50 Recycle
3 Toluene (Recd) 280 1.35 13.50 Recycle
4 MDC (Recd) 145 0.58 5.80 Recycle
5 Distillation + Drying Loss 55 0.63 6.30
6 Residue 10 0.05 0.50
7 Effluent 975 4.88 48.80
8 Waste Carbon 20 0.10 1.00
Total 2245
2 5 . P r o d u c t : 1 - { 4- [ 2 - I s o p r o p o x y e t h o x y ) m e t h y l ] p h e n o x y } - 3 -
( i s o p r o p y l am i n o ) p ro p a n o l : B i s o p r o l o l f u m a r a t e
Ø A ) R e a c t i o n C h e m i s t ry
STAGE 1 :
MW 124.14
4 Hydroxy Benzyl alcohol
O
CH3
CH3
OH
MW 104.15
2 Isopropoxy ethanol
+
OH
OH
OH
OO
CH3
CH3
MW 210.27
Stage 1
STAGE 2 :
+
MW 266.33
Stage 2
OH
OO
CH3
CH3
MW 210.27
Stage 1
ClO
O
OO
CH3
CH3
O
NaOH
MW 92.52
Epichloro hydrine
STAGE 3 :
+NH2
CH3
CH3
MW 59.11
Iso Propyl Amine
MW 266.33
Stage 2
O
OO
CH3
CH3
O
1-{4-[2-Isopropoxyethoxy)methyl]phenoxy}
-3-(isopropylamino) propanol bisoprolol
MW 325.44
O NH
OHCH3CH3
OO
CH3 CH3
STAGE 4 :
1-{4-[2-Isopropoxyethoxy)methyl]phenoxy}
-3-(isopropylamino) propanol bisoprolol
MW 325.44
O NH
OHCH3CH3
OO
CH3 CH3
Fumeric Acid
MW 441.51
O NH
OHCH3CH3
OO
CH3 CH3 O
OH
O
OH
.
MW 116.07
1-{4-[2-Isopropoxyethoxy)methyl]phenoxy}
-3-(isopropylamino) propanol bisoprolol fumarate
Ø B ) P r o c es s F l o w D i a g r am
4 Hydroxy Benzyl Alcohol
2 Isopropoxy ethanol
Amberlyst-15
Sodium Carbonate
S T A G E 1Solvent Recovery
Evaporation Loss
Stage 1
Sodium Hydroxide (20%)
Epichloro Hydrine
Toluene
Water
S T A G E 2
Solvent Recovery
Evaporation Loss
Organic Residue
Effluent
S T A G E 3
Solvent Recovery
Evaporation Loss
Organic Residue
Carbon
Stage 3
Acetone
Fumaric Acid
Carbon
S T A G E 4
Solvent Recovery
Evaroparation Loss
Residue
Waste Carbon
F I N I S H
P R O D U C T
Stage 2
Methanol
Sodium Borohydride
Iso Propyl amine
MDC
Ø C ) M a n u f a c t u r i n g P r o c e s s
STAGE 1 :
• Charged 4-hydroxy benzyl alcohol and 2- Isopropoxy ethanol in Reactor at RT
• Amberlyst-15 is added slowly in above reaction mass
• The Amberlyst-15 resin is filtered and washed with 2-Isopropoxy ethanol
• The reaction mixture is treated with sodium carbonate
• The sodium carbonate is filtered and the reaction mixture is taken for distillation to
recover excess of 2-Isopropoxy ethanol to obtain Stage 1
STAGE 2 :
• Charged 20% Sodium Hydroxide solution and stage 1 in reactor.
• The aqueous solution of sodium salt of stage 1 is reacted with epichlorohydrin
• The reaction mixture is then extracted twice with Toluene
• The combined Toluene extract is stirred with solid sodium hydroxide to convert the
intermediate stage
• The reaction mixture is washed with water three times and the Toluene layer is taken
for distillation
• The product is further purified by high vacuum distillation to obtain purified Stage 2
STAGE 3 :
• Charged stage 2 and methanol in reactor.
• Catalytic amount of sodium borohydride is added to it in small lots.
• The reaction mixture is stirred for 1 hr and added to cooled isopropyl amine. The
reaction mixture is stirred hrs and heated to reflux
• The excess of Isopropyl amine and methanol is removed by distillation
• The residual oil is taken in dichloromethane and washed thrice with water
• Bisoprolol base is obtained as an oil after removal of solvent by distillation
STAGE 4 :
• Charged Acetone in Reactor at RT
• Charged 1-{4-[(2-Isopropoxyethoxy)methyl]phenoxy}-3-(isopropylamino) Propanol in
above solvent
• The reaction mixture was heated and stirred
• Charged Fumaric Acid in above solvent
• The reaction mixture was heated and then add carbon and stirred. filter the RM
• The reaction mixture was cooled.
• Then Chilled the reaction mixture
• Maintain same temp for 4 hrs.
• Filter the solid mass and dry it.
Ø D ) S u m m a ry o f M a s s
Capacity, Mt/Month : 10.00
Batch Size, Kg : 400
Working Days : 26
Sr.
No Name of Raw Material Kg/batch
Kg/Kg of
Product MT/Month Remarks
Input
1 4-hydroxy benzyl alcohol 150 0.38 3.75
2 2- Isopropoxy ethanol 140 0.35 3.50
3 Amberlyst-15 50 0.13 1.25
4 Sodium Carbonate 140 0.35 3.50
5 Sodium Hydroxide 60 0.15 1.50
6 Epichlorohydrin 115 0.29 2.88
7 Toluene 1100 2.75 27.5
8 Sodium borohydride 15 0.04 0.38
9 Methanol 1250 3.13 31.25
10 Isopropyl amine 110 0.28 2.75
11 MDC 850 2.13 21.25
12 Acetone 1600 4.00 40.00
13 Fumaric Acid 130 0.33 3.25
14 Carbon 12 0.03 0.30
15 Water 1500 3.75 37.50
Total 963
Output
1 Final Product 400 1.00 10.00 Finished product
2 Toluene Recd 1040 2.60 26.00 Recycle
3 Methanol Recd 1190 2.98 29.75 Recycle
4 MDC Recd 760 1.90 19.00 Recycle
5 Acetone Recd 1490 3.73 37.25 Recycle
6 Distillation + Drying loss 425 1.06 10.63
7 Residue 20 0.05 0.50
8 Carbon waste 25 0.06 0.63
9 Effluent 1872 4.68 46.80
Total 963
26. Product : 5-Methyl-1-phenylpyridin-2(1H)-one: Pirfenidone
Ø A ) R e a c t i o n C h e m i s t ry
+K
2CO
3
5 Methyl 1 H
Pyrrolin-2-One
MW 109.12
Br
Bromo Benzene
MW 157.01
CH3
NH
O
5-Methyl-1-phenyl
pyridin-2(1H)-one pirfenidone
MW 185.22
CH3
N O
MW 138.21
+ KBr + H2O + CO
2
Ø B ) P r o c es s F l o w D i a g r am
Bromo Benzene
5 Methyl 1 H Pyridin-2-One
Potassium Carbonate
Copper Oxide
Dimethyl Formamide
Toluene
Sodium Hydroxide
Conc HCl
Water
S T A G E
Evaporation Loss
Effluent
Process Emissions
Residue
F I N I S H
P R O D U C T
Ø C ) M a n u f a c t u r i n g P r o c e s s
• Charge Dimethylformamide, Bromobenzene and Potassium Carbonate in Reactor.
• Charge Copper Oxide and 5-Methyl-1H-pyridin-2-one in above RM. Heat the mass.
• Remove Dimethylformamide under vacuum.
• After completion of the reaction, extracted the product in Toluene.
• Solvent was removed under vacuum to get crude material
• The solid was treated with aqueous Hydrochloric acid and isolated by adjusting pH to
basic using Sodium Hydroxide to get solid.
• The crude solids are washed with water.
• Dry the product to give White to off white solid
Ø D ) S u m m a ry o f M a s s
Capacity, Mt/Month : 10.00
Batch Size, Kg : 200
Working Days : 26
Sr.
No Name of Raw Material Kg/batch
Kg/Kg of
Product MT/Month Remarks
Input
1 Di methyl formamide 450 2.25 22.50
2 Bromo benzene 215 1.08 10.80
3 Potassium Carbonate 110 0.55 5.50
4 5-Methyl-1H-pyridin-2-one 38 0.19 1.90
5 Copper Oxide 140 0.70 7.00
6 Toluene 320 1.60 16.00
7 Sodium Hydroxide 60 0.30 3.00
8 Conc HCl 180 0.90 9.00
9 Water 100 0.50 5.00
Total 1613
Output
1 Final Product 200 1.00 10.00 Finished product
2 Di methyl formamide 395 1.98 19.80 Recycle
3 Toluene 310 1.40 14.00 Recycle
4 Residue 15 0.08 0.80
5 Drying loss 130 0.65 6.50
6 Effluent 593 2.97 29.70
Total 1613
27. Product: Ursodeoxycholic acid
Ø A ) R e a c t i o n C h e m i s t ry
O
OH
O
OH
CH3 H
CH3
H
H
CH3
H
H
3-Hydroxy-7-Ketocholanic Acid
MW 390.56
Ursodeoxycholic Acid Imidazole Salt
MW 461.64
OH
OH
O
OH
CH3 H
CH3
H
H
CH3
H
H
N
NH
Sodium
Phosphoric Acid
Imidazole
OH
O
O
OH
CH3 H
CH3
H
H
CH3
H
H
CH3
MW 406.60
OH
OH
O
OH
CH3 H
CH3
H
H
CH3
H
H
Ursodeoxycholic Acid
MW 392.57
Ursodeoxycholic Acid methyl ester
Phosphoric Acid
Methanol Sodium hydride
Ø B ) P r o c es s F l o w D i a g r am
Butanol
3-Hydroxy-7-ketocholanic acid
Sodium Metal
Phosphoric acid 85%
Imidazole
Water
S T A G E 1
Solvent Recovery
Evaporation Loss
Effluent
Stage 1
Butanol
Phosphoric acid 85%
Methanol
Conc HCl
S T A G E 2
Stage 2
Sodium Hydroxide
Water
Methanol
Conc HCl
S T A G E 3
Solvent Recovery
Evaporation Loss
Organic Residue
Effluent
F I N I S H
P R O D U C T
Solvent Recovery
Evaporation Loss
Organic Residue
Effluent
Ø C ) M a n u f a c t u r i n g P r o c e s s
S t e p 1
• Charged butanol and 3-hydroxy-7-ketocholanic acid into a reactor.
• The mass was brought to reflux temperature then metallic sodium was added in
portions.
• The mass was maintained at reflux for about 30 minutes, and then removed solvent
under vacuum.
• Water and phosphoric acid 85% were subsequently added. The mass was heated to
around 70°C.
• Charged imidazole in to the Reaction mass.
• The suspension was brought at a temperature of 5°-10°C, and then centrifuged and
the solid residue was washed with water.
• Dry the product to give White to off white solid
S t e p 2
• Charged step 1, butanol and phosphoric acid 85% into a reactor.
• The mixture was heated until complete dissolution. The lower aqueous phase was
separated and eliminated.
• The organic phase was brought to dryness by distillation, and the residue added or
dissolved with methanol and hydrochloric acid.
• The mass was cooled to 0°-5°C, then the suspension was centrifuged and the solid
washed with chilled methanol.
• Dry the product to give White to off white solid
S t e p 3
• Charged step 2, water and sodium hydroxide were into a reactor.
• The mass was heated at reflux and maintained for 2 hours, and then water was added.
• The solution was brought to 60-65 °C then methanol and Conc HCl were added
• The suspension was stirred at 60°-65°C for at least 15 minutes, then cooled to 20°-25°C
and stirred at this temperature for at least 30 minutes. The suspension was
centrifuged and the solid washed with methanol and water.
• Dry the product to give White to off white solid
Ø D ) S u m m a ry o f M a s s
Capacity, Mt/Month : 10.00
Batch Size, Kg : 200
Working Days : 26
Sr.
No Name of Raw Material Kg/batch
Kg/Kg of
Product MT/Month Remarks
Input
1 3-hydroxy-7-ketocholanic acid 215 1.08 10.80
2 Butanol 450 2.25 22.50
3 Sodium metal 30 0.15 1.50
4 Phosphoric acid 85% 185 0.93 9.30
5 Imidazole 45 0.23 2.30
6 Methanol 950 4.75 47.50
7 Sodium Hydroxide 30 0.15 1.50
8 Conc HCl 210 1.05 10.50
9 Water 200 1.00 10.00
Total 2315
Output
1 Final Product 200 1.00 10.00 Finished product
2 Butanol 435 2.08 20.80 Recycle
3 Methanol 912 4.38 43.80 Recycle
4 Residue 15 0.08 0.80
5 Drying loss 68 0.63 6.30
6 Effluent 685 3.43 34.30
Total 2315
ANNEXURE – IV
_______________________________________________________________________
DETAILS OF WATER CONSUMPTION AND WASTEWATER GENERATION
Note: Domestic waste water is to be sent to Septic Tank & Soak Pit.
Sr.
No.
Category Proposed Scenario (m3/day)
Water Consumption Waste Water
Generation
1. Industrial
Process 9.0 18.9
Boiler 10 1
Cooling 10 1
Washing 1 1
APCM 2 2
2. Gardening 2 -
3. Domestic 5 4
Total (Industrial) 32.0 23.9
Total 39.0 27.9
WATER BALANCE
Raw Water 39.0 KL/Day
Domestic 5.0 KL/Day
Industrial 32.0 KL/Day
Gardening 2.0 KL/Day
Process: 9.0 KL/Day
Cooling 10 KL/Day
4.0 KL/day Septic Tank &
Soak Pit
18.9 KL/Day
23.3 KL/Day ETP (Primary treatment & Secondary Treatment)
1.0 KL/Day
CETP for further treatment &
disposal
Washing 1.0 KL/Day
1.0 KL/Day
APCM- 2.0 KL/Day
2.0 KL/Day
Boiler 10 KL/Day
1.0 KL/Day
High COD & High TDS � 0.6 KL/Day
Common MEE for further
treatment & disposal
ANNEXURE - V
EFFLUENT TREATMENT SYSTEM
Stream I (Low COD & TDS Stream) = 24 KL/Day
First all non-toxic and biodegradable streams (low & medium COD& TDS) of wastewater shall
pass through Screen Chamber (SC-01) where floating material shall be removed with help of
Screen (S-01). Then effluent shall be passed through Oil & Grease Removal Tank (OGRT-01).
Automatic mechanical Oil Skimmer shall be provided in the OGRT to remove floating oil and
grease from the wastewater to Oil & Grease Collection Tank (OGCT-01). Then effluent shall be
collected in Collection cum Equalization tank-1 (CET-01). Pipe grid is provided at bottom of the
CET-01 to keep all suspended solids in suspension and to provide proper mixing. 2 nos. of Air
Blowers (1W+1 stand-by) shall supply air through to pipe grid.
Then after, equalized wastewater shall be pumped to Neutralization Tank-1 (NT-01) where the
continuous addition and stirring of Caustic solution is done to maintain neutral pH of
wastewater from Caustic Dosing Tanks (CDT-01) as per requirement by gravity. Then after,
neutralized wastewater shall go to Flash Mixer-1 (FM-01) by gravity. Alum and Polyelectrolyte
shall be dosed from Alum Dosing Tank (ADT-01) and Polyelectrolyte Dosing Tank (PEDT-01)
respectively by gravity into FM-1 to carry out coagulation by using a Flash Mixer. Then after,
coagulated wastewater shall be settled in Primary Clarifier (PCF-01). Clear supernatant from
PCL shall be passed in Aeration Tank (AT-01)
Here, biodegradation of organic matter of the wastewater shall be carried out by bacteria
(suspended growth) in the AT-01 and for that oxygen shall be supplied by 2 nos. of air blowers
(B-02) through diffusers. Air blowers also keep MLSS in suspension. Treated effluent will be
sent to CETP for further treatment.
Then after, wastewater shall go to Secondary Clarifier-1 (SCL-01) from AT-1. Here, the
suspended solids shall be settled. Sludge shall be removed from bottom of SCL-01 and pumped
to AT-1 to maintain MLSS and excess activated sludge shall be sent to Sludge Sump (SS-01).
SIZE OF TANKS (Stream I)
SIZE OF TANKS (Stream I)
S.N. Name of unit Size (m x m x m) No
.
MOC/ Remark
Stream I (Low COD & TDS Stream) 24 M3/D
1 Screen Chamber (SC-01) [0.5x0.5x1 depth] 1 RCC M25+A/A Bk.
Lining
2 Collection cum Equalization
Tank-1 (CET-01)
[2.5x2.5x 4 depth] 1 RCC M25+A/A Bk.
Lining
3 Neutralization Tank (NT-01) [2.5x2.5x 4 depth] 1 RCC M25+A/A Bk.
Lining
4 Flash Mixer-1 (FM-01) 0.8 x 0.8 x (1.5 LD +0.5
FB)
1 RCC M25
5 Primary Clarifier (PCL-01) [2.5x2.5x 3 Height] 1 RCC M25
6 Aeration Tank-1 (AT-01) [5.0 x5.0 x 7.0 (4.0
depth+ 3.0 above ground
level)]
1 RCC M25
7 Secondary Clarifier-1 (SCL-
01)
[2.5x2.5x 3 Height] 1 RCC M25
RCC M25 = REINFORCED CEMENT CONCRETE (M 25 GRADE)
PCC = PLAIN CEMENT CONCRETE
PP = POLYPROPELENE
MSEP = MILD STEEL EPOXY PAINTED
SS = STAINLESS STEEL
BLOCK DIAGRAM FOR EFFLUENT TREATMENT PLANT (Stream -I)
Screen Chamber Oil & Grease
Trap
Collection cum
equalization
tank
Neutralization
tank
Primary Settling
tank
Aeration tank
Secondary
Settling tank
CETP
EXPECTED CHARACTERISTIC OF EFFLUENT (STREAM-I)
Sr.
No.
Category of Wastewater Before Treatment After Treatment
1 pH 3.5-6.5 6.5-8.0
2 COD (mg/L) 20000 10000 [CETP –ETL grant
permission]
3 BOD3 (mg/L) 7000 3000
4 TDS (mg/L) 3500 3500
5 Ammonical Nitrogen (mg/L) 100 50
EXPECTED CHARACTERISTIC OF EFFLUENT (STREAM-II)
Sr.
No.
Category of Wastewater Before Treatment
1 pH 2-10
2 COD (mg/L) 55000
3 BOD3 (mg/L) 12000
4 TDS (mg/L) 40000
5 Ammonical Nitrogen (mg/L) 500
ANNEXURE - VI
HAZARDOUS WASTE GENERATION AND DISPOSAL
CAT.
NO.
HAZARDOUS
WASTE
PROPOSED
TOTAL
(MT/Month)
METHOD OF DISPOSAL
5.1 Used Oil 0.02 Collection, Storage, Transportation Re use or Sent to GPCB
approved recycler
33.1 Discarded barrels/
containers/ liners
2 Collection, Storage, Transportation, decontamination and
Sent back to supplier / to GPCB approved recycler
35.3 ETP Sludge 10 Collection, Storage, Transportation and Sent to TSDF site for
secured land filling
20.3 Distillation Residue 6 Collection, Storage, Transportation and sell to Cement
Industries for Co-processing or Disposal at Common
Incineration Site
28.3 Spent Carbon 4
Collection, Storage, Transportation and co-processing in
cement industries or disposal at Common Incineration Site
28.2 Spent Catalyst 1 Collection, Storage, Transportation and give to manufacturer
for regeneration for reuse or sell to end user.
28.6 Spent solvents 150 Collection, Storage, recovered through in house distillation
and or sent for distillation job work to authorized recycler
then reuse in process.
ANNEXURE-VII
_______________________________________________________________________
DETAILS OF STACK AND VENT and FUEL & ENERGY REQUIREMENT
DETAILS OF FLUE GAS EMISSION THROUGH STACK ATTACHED TO BOILER
SR.
NO.
TYPE
OF
STACK
PARTICULAR STACK
HEIGHT
(M)
STACK
DIAMETER
(M)
AIR EMISSION FUEL APCM
POLLUTANT CONC.
1. Thermic
Fluid
Heater
(6 Lac
Kcal)
STACK-1 30 0.6
PARTICULATE
MATTER
SO2
NOX
≤ 150
MG/NM3
≤ 100
PPM
≤ 50
PPM
Natural
Gas
--
2. Steam
boiler(3
TPH)
Agro
Waste
Multi
cyclone
Separator
with Bag
Filter
DETAILS OF PROCESS EMISSION THROUGH VARIOUS VENTS
SR.
NO.
TYPE OF
STACK
AIR POLLUTION
CONTROL SYSTEM
HEIGHT (M) AIR EMISSION
POLLUTANT CONC.
1. Process Vet
Two Stage Scrubber 12.5 HCL
SO2
HBR
NH3
≤ 20 MG/NM3
≤ 40 MG/NM3
≤ 5 MG/NM3
≤ 175 MG/NM3
APCM:
MODE OF DISPOSAL OF SCRUBBING MEDIA:
All the SO2 gas emitted from sulfonator reactor is being pulled in by wet scrubbers and let
out in atmosphere as a clean gas as per the model Diagram given below.
The
gas absorbed by
scrubber is
passed through
water flow and
that converts
water acidic. This
acidic water is neutralized with proper base (NaOH or CaCo3).
The resultant is salt and water. This water is changed periodically and again neutralized, if
required and allowed to evaporate in the Natural dehydrating pit.
The resultant Scrubbing media is salt solution, scrubbing media is very much minimal and
Scrubbing media use in resinex as raw material.
• TOTAL POWER REQUIREMENT (KW) (PROPOSED)
Sr.
No. Scenario Power Requirement (KVA)
1 Power 500
SOURCE OF POWER (KW)
FUEL REQUIREMENT
Sr.
No.
Fuel Fuel Quantity
1 Natural Gas 4,200 NM3/Day
2 Agro waste 10 MT/Day
3 HSD 20 Liters/Hr
Sr. No. Scenario SEB/Grid DG Sets
(emergency used only)
1 Proposed DGVCL 250 KVA
ANNEXURE-VIII
______________________________________________________________________________
STORAGE DETAILS OF HAZARDOUS LIQUID CHEMICALS
Sr.
No.
Name of the
Hazardous
Substance
Maximum
Storage
Mode of
Storage
Actual
Storage
State &
Operating
pressure &
temperature
Possible type of
Hazards
1 Methanol 20 MT Tank 20 MT x 1 NTP Flammable/
Toxic
2 EDC/MDC 20 MT Tank 20 MT x 1 NTP Flammable/
Toxic
3 DMF 10 MT Tank 20 MT x 1 NTP Flammable/
Toxic
4 Toluene 20 MT Tank 20 MT x 1 NTP Flammable
5 Acetone 20 MT Tank 20 MT x 1 NTP Flammable
6 Ethyl Acetate 20 MT Tank 20 MT x 1 NTP Flammable
7 IPA 20 MT Tank 20 MT x 1 NTP Flammable
ANNEXURE-IX
_______________________________________________________________________
SOCIO - ECONOMIC IMPACTS
1) EMPLOYMENT OPPORTUNITIES
During construction phase, skilled and unskilled manpower will be needed. This will
temporarily increase the employment opportunity. Secondary jobs are also bound to be
generated to provide day-to-day needs and services to the work force. This will also
temporarily increase the demand for essential daily utilities in the local market.
The manpower requirement for the proposed expansion is expected to generate some
permanent jobs and secondary jobs for the operation and maintenance of plant. This will
increase direct / indirect employment opportunities and ancillary business development to
some extent for the local population.
This phase is expected to create a beneficial impact on the local socio-economic
environment.
2) INDUSTRIES
During construction of the project, the required raw materials and skilled and unskilled
laborers will be utilized maximum from the local area. The increasing industrial activity will
boost the commercial and economical status of the locality, to some extent.
3) PUBLIC HEALTH
During construction period, workers will be provided with basic amenities like safe water
supply, low cost sanitation facilities, first aid, required personal protective equipment, etc.
Otherwise, there could be an increase in diseases related to personal hygiene.
Emission, if uncontrolled from process and utility stacks may cause discomfort, burning of
eyes to the recipients in the down wind direction. This may be caused due to the failure of
control equipment / process. The company regularly examines, inspects and tests its
emission from sources to make sure that the emission is below the permissible limit.
Hence, there will not be any significant change in the status of sanitation and the
community health of the area, as sufficient measures have been taken and proposed under
the EMP.
4) TRANSPORTATION AND COMMUNICATION
Since the existing factory is having proper linkage for the transport and communication, the
development of this project will not cause any additional impact.
In brief, as a result of the expansion there will be no adverse impact on sanitation,
communication and community health, as sufficient measures have been proposed to be
taken under the EMP. The proposed expansion is not expected to make any significant
change in the existing status of the socio - economic environment of this region.
ANNEXURE-X
___________________________________________________________________________
PROPOSED TERMS OF REFERENCE FOR EIA STUDIES
1. Project Description
• Justification of project.
• Promoters and their back ground
• Project site location along with site map of 5 km area and site details providing various
industries, surface water bodies, forests etc.
• Project cost
• Project location and Plant layout.
• Existing infrastructure facilities
• Water source and utilization including proposed water balance.
• List of Products & their capacity
• Details of manufacturing process of proposed products
• List of hazardous chemicals
• Mass balance of each product
• Storage and Transportation of raw materials and products.
2. Description of the Environment and Baseline Data Collection
• Micrometeorological data for wind speed, direction, temperature, humidity and rainfall
in 5 km area.
• Other industries in the impact area
• Prevailing environment quality standards
• Existing environmental status Vis a Vis air, water, noise, soil in 5 km area from the project
site.
• Ground water quality at 5 locations within 5 km.
• Complete water balance
3. Socio Economic Data
• Existing socio-economic status, land use pattern and infrastructure facilities available in
the study area were surveyed.
4. Impacts Identification And Mitigatory Measures
• Identification of impacting activities from the proposed project during construction and
operational phase.
• Impact on air and mitigation measures including green belt
• Impact on water environment and mitigation measures
• Soil pollution source and mitigation measures
• Noise generation and control.
• Solid waste quantification and disposal.
• Control of fugitive emissions
5. Environmental Management Plan
• Details of pollution control measures
• Environment management team
• Proposed schedule for environmental monitoring including post project
6. Risk Assessment
• Objectives, Philosophy and methodology of risk assessment
• Details on storage facilities
• Process safety, transportation, fire fighting systems, safety features and emergency
capabilities to be adopted.
• Identification of hazards
• Consequence analysis
• Recommendations on the basis of risk assessment done
• Disaster Management Plan.
7. Information for Control of Fugitive Emissions
8. Information on Rain Water Harvesting
9. Green Belt Development plan