a report overview on drug production

7/30/2019 A REPORT OVERVIEW ON DRUG PRODUCTION

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1.0 CHAPTER ONE

1.1INTRODUCTION:Pharmaceutical Laboratory deals with the production of various drugs. The drug may

be produced in liquid form, solid form or powdery form. It can be used orally or by

applying it to the external part of the body.

The laboratory scientist always carry out different analysis on the raw materials and

the finished products whether the finished products comply with the specification

(standard) or not.

1.2BACKGROUND:This report was based on different types of drugs that is being produced in the

laboratory and some analysis that are being carried out on the drugs (finished products)

to ascertain that the drugs can be released for selling, during the period of my Student

Industrial Work Experience Scheme (SIWES) under the supervision of the laboratory

scientist of DeShalom Pharmaceutical Lab. Nig. Ltd. Ilesha.


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1.3OBJECTIVES OF SIWES:The innovative scheme (SIWES) is initiated by the federal government and

supervised/coordinated by ITF. More so, it has a policy documentation number 1 of

1973, which establish the scheme, and includes the following objectives:

- Preparation of the student for industrial work situation that they are likely to meet

after graduation.

- Provision of avenue for students in higher institution of learning to acquire industrial

skill and experience during the course of study.

- The Student Industrial Work Experience Scheme (SIWES) is a means of exposing

students to the labour market.

- To expose student to method and techniques in handling equipment and

machineries that they may not be available in their institutions.

- It gives student the practical knowledge of theoretical studies they have learnt in

school.


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- It widen the students horizon to opportunities in various field of study.

1.4 RELEVANCE OF SIWES TO BIOCHEMISTRY:

The relevance of siwes to student cannot be over emphasized as ITF has a strong vision

backing the initiation of SIWES. Therefore, as a biochemistry student, I have acquired a lot

of benefits during the course of my SIWES which are listed below:

1. SIWES has helped me in apply the theoretical principles I have learnt in school to real

job situation and this has led to a better understanding of my course.

2. It has given me the privilege to see and operate some equipment and apparatus that

I have not seen or touch before.

3. SIWES has helped in building good and formidable human relations in an industrial

set up, unlike the lecturetostudent relationship on campus.


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2.0 CHAPTER TWO

2.1 DESCRIPTION OF THE ESTABLISHMENT:

DeShalom Pharmaceutical Lab. Nig. Ltd. Is a drug manufacturing company

located at KM 4, IlokoIjesha Road,Ilesha, Osun State, Nigeria.

The company was incorporated in the year 1998 in Nigeria. The company is 100%

indigenous to Nigeria and fully owned by Nigerian. The company is manufacturing

OralLiquid Drugs, External Liquid Drugs, Tablet Drugs and Flavoured Drinks.

2.2 OBJECTIVES OF THE ESTABLISHMENT:

- To enhance quality health services.

- To eradicate the rate at which people are suffering and dying of minor and major

diseases.

- To boost the activities of some cells like White Blood Cell (Immune Cells), Red

- Blood Cells (Erythrocytes) and other cells in the body.

- To provide job opportunities for qualified scientist and unskilled labourers.


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2.3 ORGANIZATIONAL STRUCTURE

2.4 UNITS OF THE ESTABLISHMENT AND THEIR FUNCTION

RAW MATERIALS STORE: All raw materials that are being used

for the manufacture of drugs are stored in this room at appropriate

temperature. This section contain two subsections. They are;

1. REJECTED MATERIALS ROOM: Rejected raw materials arestored in this room.

RECEPTION/ADMIN OFFICE

PRODUCTION ROOM QUALITY ASSURANCE DEPARTMENT

TABLET

ROOM

ORAL

LIQUID

LINE

EXTERNAL

PRODUCT

LINE

EQUIPMENT

LAB

CHEMICAL

LAB

MICRO

BIOLOGY

LAB


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2. DISPENSING ROOM: Weighing of raw materials are done in thisroom, after which the weighed raw materials are being transferred

to the mixing room.

PACKAGING MATERIALS STORE: Packaging materials like

labels, leaflet or fliers, jackets and external cartons were stored in this

room.

BOTTLING RINSING ROOM: Plastics and bottles of different size

are being washed in this room by following the Standard Operating Procedure (SOP).

QUALITY ASSURANCE DEPARTMENT: This department

dictate whether the raw materials are to be used or not and whether the

finished products are to be released out for selling or not. This

department has three arms;

1. EQUIPMENT LABORATORY: Laboratory equipment were stored in

this room.

2. CHEMICAL LABORATORY: All chemical analysis on either rawmaterials or finished products are being executed here.

3. MICROBIOLOGY LABORATORY: Analysis of finished product isdone in this laboratory.


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ENGINEERING ROOM: All tools that are being used by the

engineers were kept here.

REFERENCE SAMPLE ROOM: Reference samples of drugs of

difference batches are kept in this room.

PRODUCTION ROOM: All sort of drugs are being produced in this

department. This department has three branches;

1. TABLET ROOM: Only tablet drugs of difference types are beingproduced in this section.

2. ORAL LIQUID LINE: Production of oral liquid drugs are done here.

3. EXTERNAL PRODUCT LINE: Drugs that are used for external part of

the body are being produced in this unit.

STORE: All drugs that are being produced in the production department of the

company were stored in this room.


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3.0 CHAPTER THREE

3.1 WATER TREATMENT: The source of water that is being using in DeShalom

Pharmaceutical Lab. is bore hole. The water is treated in order to get rid of some micro-

organism and metals like magnesium ion (Mg2+), Calcium ion (Ca2+) etc.

METHOD:

- The water is pumped from the bore hole into a 1,500Litre surface tank.

- The first treatment is chlorination (chlorine disinfection) which is done by the

addition of 6% DeShalom chlorine solution to the water that has been pumped

into the surface tank. This is done to make the water microbial free and to introduce

oxidation.

- Add of 100g sodium bicarbonate (Na2CO3) to soften the water and to shift the pH

value from acidic towards neutral or basic medium.

- The water is allowed to pass through sand bed filtration. There are two types of sandbed filtration, they are;


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1. Rapid sand bed filtration.

2. Slow sand bed filtration by composite filter.

- The water is transferred into the holding tank of 10,000L and then pass through

series of micron filters ranging from 5 micron to 0.5 micron.

5micron 2micron 2micron 1micron 0.5micron

deionizer

- The water is passed through the deionizer (an ion exchange resin i.e Na+ and K+

exchange resin) which remove all ions except Na+ and K+.

- The water is then exposed to ultra violet sterilizer so as to screen and to kill any

microbe that may be present.

Water source 1500L Surface tank Sand bed 5micron filter 10000L

Storage tank Series of micron filters ranging from 5micron filter to

0.5micronfilter Deionizer with ion exchange resin Ultra Violet sterilizer.


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3.2 PRODUCTION OF DRUGS

PRODUCTION OF PEACETONE SYRUP (SHALOM BLOOD TONIC):

MATERIALS: Hot water (95oC - 100oC), Sugar, Carboxy Methyl Cellulose (CMC),

Xanthangum, MethylParaben, Propyl Paraben, 95% Ethanol, Glycerine, Ferric Ammonium

Citrate, Cold Water (Treated water), Mixer, Bowl and Thermometer.

PROCEDURE: Pour part of the sugar into the mixer.

Add hot water and switch on the mixer.

Add Carboxy Methyl Cellulose and Xanthan gum one after the other.

Leave it for some minutes to gel out (i.e to form syrup).

Dissolve methyl and propyl paraben in ethanol.

Pour the solution into the syrup in the mixer gently.

Add glycerine.

Dissolve the remaining sugar and ferric ammonium citrate in a container

containing hot water.

Pour the solution into the mixer.

Add rhasberry and fill the mixer to the desire level with cold water.

Leave it for some minutes to form homogenous mixture.

Transfer it to the holding tank.


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PRODUCTION OF VITAMIN C SYRUP:

MATERIALS: Hot water (65oC - 70oC), Sugar, Soda-Ash, CMC, MethylPropyl

Paraben, 95% Ethanol, Glycerine, Sorbitl, Salt, Dextrose Powder, Ascorbic Acid, Pineapple

Flavour, Ethylene Diamine Tetra Acetic Acid (EDTA), Metabisulphite, Concentrated Hydro

Chloric Acid (HCl), Colourant, Thermometer, Bowls and Mixer.

PROCEDURE: Pour sugar into the mixer and add sodaash.

Transfer hot water into the mixer and switch on the mixer.

Add CMC and leave the mixture to form gel.

Add Conc. HCl to the syrup formed follow by glycerine.

Dissolve salt, sorbitol, dextrose powder, EDTA and metabisulphite in a

bowl Containing hot water (65oC70oC) and pour the solution into the mixer containing

syrup.

Also, dissolve ascorbic acid in a separate bowl containing hot water and

pour the solution into the mixer as well.

Pour methylpropyl paraben solution (methylpropyl paraben that has

been dissolved in 95% ethanol) into the mixer.

Add pineapple flavour and colorant one after the other.

Make up the solution in the mixer to the desire level with hot water and

leave for some minutes to homogenize.


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Transfer the mixture into the holding tank.

NOTE: The temperature of the hot water used should not exceed 70oC during the

production of the Syrup and the temperature must be reduced to 60oC before the

addition of ascorbic acid.

PRODUCTION OF MIST POT CITRATE:

MATERIALS: Hot water (90oC100

oC), Potassium Citrate, Citric Acid, Sorbitol,

Methyl Paraben, Chloroform, Lemon flavour, Colorant, Thermometer, Bowl and Mixer.

PROCEDURE: Pour hot water into the mixer and switch on the mixer.

Add potassium citrate, citric acid, sorbitol solution, methyl paraben

Solution (methyl paraben that has been dissolved in hot water), chloroform, lemon

flavour and colorant one after the other.

Fill up the mixer to the level of interest and leave for some minutes to

homogenize.

Transfer it into an holding tank and leave it for about three days to

improve its colour before packaging.

PRODUCTION OF SHALOM COF SYRUP:

MATERIALS: Treated Water (i.e cold water), CMC, Xanthan Gum, Aspartame, Methyl


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Propyl Paraben, 95% Ethanol, Sorbitol, Ammonium Chloride, Ammonium Bicarbonate,

Chlorpheniramine, Sodium Citrate, Liquorise Block, Peppermint oil, Dextrose Powder,

bowl and mixer.

PROCEDURE: Transfer treated water into the mixerandswitch on the mixer.

Add CMC, xanthan gum and aspartame.

Leave it for some minutes to form gel.

Pour methylpropyl paraben solution into the mixer.

Dissolve sorbitol, chlopheniramine, ammonium bicarbonate, ammonium

chloride and sodium citrate in a bowl containing cold water.

Pour the solution into the mixer.

Dissolve dextrose powder in cold water.

Pour the solution into the mixer as well.

Pour liquorise block solution and add peppermint oil.

Use cold water to make up the mixture to the quantity desired.

Leave for some minutes to homogenize.

Transfer it into an holding tank.


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PRODUCTION OF PARACETAMOL SYRUP:

MATERIALS: Hot water (95oC100

oC), CMC, Sugar, MethylPropyl Paraben, 95%

Ethanol, Glycerine, Sorbitol, Paracetamol Powder, Colorant, Rhasberry, Cold Water,

Thermometer, Bowl and mixer.

PROCEDURE: Pour sugar into the mixer and transfer hot water into it.

Switch on the mixer and add CMC.

Leave for some minutes to gel out.

Dissolve the remaining sugar and the sorbitol in a separate bowl

containing cold water and pour the solution into the mixer.

Add glycerine.

Dissolve methylpropyl paraben and paracetamol powder in 95% ethanol

in a separate bowl and pour the solution into the mixer as well.

Add rhasberry and colorant.

Fill the mixer with cold water to the desire litre.



PRODUCTION OF MIST MAG (NON SYRUP):

MATERIALS: Treated water, Sodium Bicarbonate, Magnesium Trisilicate, Light-


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Magnesium Carbonate, Sorbitol, MethylPropyl Paraben, 95% Ethanol, Peppermint Oil,

chloroform and mixer.

PROCEDURE: Transfer cold water into the mixer and switch the mixer on.

Add sodium bicarbonate, magnesium trisilicate and light magnesium-

carbonate.

Add sorbitol solution, methylpropyl paraben solution.

Also, add peppermint oil and chloroform.

Make it up to the desire level with cold water.

Transfer into an holding tank.

PRODUCTION OF SHALOM MAG (WITH SUGAR):

MATERIALS: Hot Water, Sugar, CMC, MistMag (without peppermint oil and

chloroform), Peppermint Oil, Cold Water and Mixer.

PROCEDURE: Pour sugar into the mixer and transfer hot water into it.

Add CMC and switch on the mixer.

Leave it for some minutes to form gel.

Transfer the mistmag that has just been prepared in another mixer into the mixer

containing syrup.

Add peppermint oil.


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Make the mixture up to the expected litres with cold water.

Leave for some minutes to mix properly.

Transfer to an holding tank.

PRODUCTION OF SHALOM MAG (NON SUGAR):

MATERIALS: Cold Water, CMC, MistMag (without peppermint oil and chloroform),

Peppermint Oil, Chloroform and Mixer.

PROCEDURE: Transfer cold water into the mixer.

Switch on the mixer and add CMC.

Leave it for some minutes to gel out.

Transfer the mistmag that has just been prepared in another mixer into

the mixer containing syrup.

Add peppermint oil and chloroform.

Make the mixture up to the expected litres with cold water.

Leave for some minutes to mix properly.



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PROCEDURE: Pour hot water into the mixer.

Pour crystal violet into the mixer and switch the mixer on.


Transfer into the holding tank.

PRODUCTION OF METHYLATED SPIRIT:

MATERIALS: Methanol, Isoproylene and Mixer.

PROCEDURE: Pour methanol and isoproylene into the mixer one after the other.

Switch on the mixer and leave for some minutes to mix properly.

PRODUCTION OF HYDROGEN PEROXIDE (H2O2):

MATERIALS: Stabilizer (mixture of benzoic acid and methanol), Concentrated

Hydrogen Peroxide, Phosphoric Acid, Cold Water and mixer.

PROCEDURE: Pour cold waterinto the mixer.

Add conc. hydrogen peroxide to the water gently.

Add phosphoric acid and stabilizer.

Make it up to the desired litres by adding cold water.

Switch on the mixer and leave for some minutes to homogenize.

NOTE: H2O2 is highly reactive, so, care must be taken during its preparation.


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4.0 CHAPTER FOUR

4.1 PHYSICOCHEMICAL ANALYSIS: The physicochemical analysis is the test usually

done on every drug being produced (finished product) to know whether the drug pass or fail.

Some fact to test on during physicochemical analysis include;

- Appearance

- Taste

- Odour

- pH

- Acidity

- Chloride

- Oxidizable Substance

- Conductivity

- Specific Gravity

-Flow Rate


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DETERMINATION OF SPECIFIC GRAVITY:

- Weigh an empty pycnometer at 25oC.

- Fill the pycnometer with the liquid to be weighed and note that the liquid

temperature is adjusted to 28oC.

- Weigh the pycnometer which contain liquid.

Let the weight of pycnometer be W1,

Let the weight of pycnometer plus liquid be W2,

Let the weight of the liquid be W3,

W3 = W2 W1

Density = Weight of liquid (sample)

Volume of liquid (sample)

Specific Gravity = Density of sample (g/ml)

Density of water (g/ml)

NOTE: Specific Gravity has no unit


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FLOW RATE DETERMINATION:

Take 20ml of the sample and make it up to 62.5ml with water.

Mix until you have homogenous solution.

Pipette 25ml of the homogenized solution and get your stop watch ready.

Simultaneously release the liquid by allowing it to flow and start your stop watch at

the same time.

Repeat the process three times and then calculate the average flow time.

Average flow time = 1st + 2nd +3rd

3

Flow Rate = Volume of homogenized sample (in cm3 or ml)

Flow time of the sample (in sec.)

NOTE: Flow Rate unit is cm3/sec or ml/sec.


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PHYSICOCHEMICAL ANALYSIS OF PEACETONE (BLOOD TONIC)

Physicochemical

parameter

Specification Result

Appearance A dark brown syrupy

liquid

Complies

Odour Strawberry like Complies

Taste Strawberry like Complies

Specific Gravity 1.1221.209 Complies

Flow Rate 1.532.53 cm s- Complies

pH 6.57.9 Complies

Assay of ferric ammonium

citrate

380420mg per 10ml Complies

NOTE: The batch number, manufacturing date and expiry date of the drug must be

recorded.


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PHYSICOCHEMICAL ANALYSIS OF VITAMIN C SYRUP

Physicochemical

parameter


Appearance A clear syrupy liquid Complies

Odour Characteristic Complies

Taste Characteristic and Citrus

like

Complies



pH 4.25.2 Complies

Assay of ascorbic acid 95105mg per 5ml Complies


recorded.

PHYSICOCHEMICAL ANALYSIS OF MIST POT CITRATE

Physicochemical

parameter


Appearance A clear liquid Complies

Odour Lemon like Complies

Taste Lemon like Complies



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pH 3.56.5 Complies

Assay of potassium citrate 1.45mg1.55mg per 10ml Complies

Assay of citric acid 2.45mg2.55mg per 10ml Complies


recorded.

PHYSICOCHEMICAL ANALYSIS OF SHALOM COF

Physicochemical

parameter


Appearance A dark brown, turbid

syrupy liquid

Complies

Odour Characteristic and

peppermint like

Complies

Taste Characteristic and

peppermint like

Complies



pH 6.57.9 Complies

Assay of ammonium

chloride



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recorded.

PHYSICOCHEMICAL ANALYSIS OF PARACETAMOL SYRUP

Physicochemical

parameter


Appearance A clear syrupy liquid Complies

Odour Apple like Complies

Taste Apple like Complies



pH 5.1

6.2 Complies

Assay of paracetamol

powder (C8 H9NO3)



recorded.


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PHYSICOCHEMICAL ANALYSIS OF MIST MAG

Physicochemical

parameter


Appearance A white suspension which

sediment very slowly &

re- disperse easily

Complies

Odour Peppermint like Complies

Taste Peppermint like Complies



pH 7.510.5 Complies

Assay of magnesium

trisilicate

1.31.7% w/v Complies

Assay of sodium

bicarbonate



recorded.


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PHYSICOCHEMICAL ANALYSIS OF SHALOM MAG

Physicochemical

parameter


Appearance A white viscous liquid

which does not sediment

Complies

Odour Peppermint like Complies

Taste Peppermint like Complies



pH 7.510.5 Complies

Assay of magnesium

trisilicate


Assay of sodium

bicarbonate



recorded.


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PHYSICOCHEMICAL ANALYSIS OF ANTI - DIARRHOEA

Physicochemical

parameter


Appearance Pink suspension Complies

Odour Characteristic Complies

Taste Sweet peppermint like Complies



pH 7.99.9 Complies

Assay of light kaolin 240260mg per 5ml Complies


recorded.

IMPORTANCE OF PHYSICOCHEMICAL ANALYSIS OF DRUGS: It helps

the laboratory analyst to know if there is mistake during the production process of the

drug.


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4.2 ASSAY OF FINISHED PRODUCT

ASSAY OF VITAMIN C

AIM: To show whether the claim complies with the specification or standard.

REAGENT: Starch mucilage, 1M H2SO4,CO2 free water, 0.05M iodine solution,

Sample.

PRINCIPLE: The principle of this experiment is redox reaction.

APPARATUS: Burette, Pipette, Dropper, Spatula, Weighing Balance, Beaker and

conical flask.

PREPARATION OF STARCH MUCILAGE

- 1g of soluble starch is weighed and then dissolve with 5ml of water.

- 95ml of boil water (CO2 free water) was added to make it up to 100ml plus

continuous stirring.

NOTE: Use immediately after preparation to get accurate result.


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1ml of 0.05M iodine 0.008806g

Convert 0.008806g to mg

1g = 1000mg

0.008806g = (0.008806 1000)mg

0.008806g = 8.806mg

When 1ml of 0.05M iodine solution 8.806mg of ascorbic acid

11.4ml of 0.05M iodine solution = (11.4 8.806)mg of ascorbic acid

= 100.3884mg of ascorbic acid

100.4mg of ascorbic acid

Hence, 5ml of the sample (Vitamin C) contain 100.4mg of ascorbic acid.

TO CALCULATE % POTENCY OF THE SAMPLE (VITAMIN C)

% potency = Result 100%

Claim


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Given; Result = 100.4mg, Claim = 100mg per 5ml of sample.

% Potency = 100.4mg 100

100mg

= 100.4%

PRECAUTIONS:

- Starch mucilage must be used immediately after its preparation to get accurate

result.

- Do not waste much time on the practical to avoid oxidation of the active

ingredient.

NOTE: The batch number, manufacturing date and expiry date of the sample must be

recorded.


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ASSAY FOR AMMONIUM CHLORIDE IN SHALOM COF

AIM: To show whether the claim complies with the specification.

REAGENT: Silver Nitrate (AgNO3), 5% w/v Potassium Chromate (K2 Cr O7),

Sample.

APPARATUS: Pipette, Burette, Beaker, Conical Flask, Weighing Balance, Spatula,

Retort Stand, Amber Bottle and Measuring Cylinder.

PROCEDURE: Weigh 4.25g of silver nitrate and put it in a beaker.

Dissolve it in water and make it up to 250ml.

Weigh 5g of potassium chromate (K2CrO7) and dissolve it in 100ml of water.

Take 1ml of the sample (cof syrup) and put it in a conical flask.

Add 25ml of distilled water.

Add 1ml of 5% w/v potassium chromate as indicator.

Titrate against 0.1M AgNO3 until a colour change is obtained.


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RESULT:

Burette Reading (cm ) Titration

Initial Burette Reading (cm ) 0.0

Final Burette Reading (cm ) 3.7

CALCULATION:

Given; each ml of 0.1M AgNO3 is equivalent to 5.349mg of ammonium chloride

(NH4Cl) i.e

1ml AgNO3 5.349mg

3.7ml AgNO3 = (3.7 5.349)mg of ammonium chloride

= 19.7913mg of ammonium chloride

19.8mg of ammonium chloride

Hence, 1ml of shalom cof (sample) contain 19.8 mg of ammonium chloride.

To calculate for 5ml of the sample;

5 19.8 = 99mg of ammonium chloride


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5ml of shalom cof (sample) contain 99mg of NH4Cl.

TO CALCULATE THE % POTENCY OF THE SAMPLE (SHALOM COF)

% potency = Result 100%

Claim

Given; Result = 99mg, Claim = 100mg per 5ml of sample.

% Potency = 99mg 100

100mg

= 99%

NOTE: Silver Nitrate must always be prepared in amber bottle.

REASON FOR ASSAY OF THE ACTIVE INGREDIENT IN DRUGS

- To avoid drug tolerance which is the reduction or loss of the normal response to

drug. Drug tolerance may be developed when taking a lower quantity of drug than

the prescribed quantity. In such cases, increase dose is required to produce the


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desired effect.

- To avoid drug intoxication which is the symptom of poisoning due to ingestion ofexcess drug than the prescribed quantity.


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5.0 CHAPTER FIVE

5.1 RECOMMENDATION:

I recommend that SIWES programme should continue because it is really a medium

that empowers and exposing student to various industrial scheme and also prepare student

ahead of the coming challenges as regards his or her field of study.

Likewise, I recommend a constant medication for every individual suffering from

one disease or the other. Drugs can be taken to increase once shelflife or healthy life.

CONCLUSION:

I absolutely submit to the fact that university education without Student Industrial

Work Experience Scheme (SIWES) is as worse as not schooling at all.

a report overview on drug production

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