The document outlines procedures for quality control and standardization of various herbal and pharmaceutical dosage forms, detailing sample preparation and identity tests for each drug. It emphasizes the importance of maintaining quality throughout every stage of drug production, from material sourcing to distribution. Each section includes descriptions, preparation methods, and tests to confirm the identity and assess degradation of specific substances.

1. Quality Control & Standardization
Of Herbals
Basic Tests For Drugs – (Dosage Forms)
By
Kaushal Kumar

2. TABLE OF CONTENTS
01 02 03 04
Introduction Description Sample
Preparation
Identity Test

3. Quality control of pharmaceutical formulations is
an essential operation in the production of drugs. It
is a procedure or set of procedures designed to
ensure the output of uniform batches of drugs
conforms to the established specifications.
Quality control is concerned with both quality and
quantity. The quality of pharmaceutical dosages
forms must be built in during plant construction,
product research and development, purchasing of
materials, production, testing, inspection,
packaging, labelling, storage, and distribution.
INTRODUCTION

4. Description : A white or creamy white powder, bulky or granular.
Preparation Of Sample: Use the powder directly as the test substance.
Barium Sulfate Powder For Suspension
Identity Test : Procedure
To 0.30 gm of the test substance, add 10 ml of water
1 gm of anhydrous sodium carbonate, boil for 5 minutes & filter
Acidify the filtrate with hydrochloric acid & add 1ml of barium chloride
White precipitate is produced

5. Description : The injection is a sterile solution containing 250 mg of amikacin sulfate in 1.0 ml of a suitable vehicle.
Preparation Of Sample: 1.0 gm of amikacin sulfate and use directly as test solution 1, dividing it into 2 equal volumes.
Dilute 1 volume of test solution 1 to 25 ml with water and use it as test solution 2.
Amikacin Sulfate Injection
Identity Test : Procedure
To 3 ml of test solution 2, add 1 ml of sodium hydroxide
Mix and add 2 ml of cobalt (II) nitrate
Violet color is produced

6. Description : The injection is a sterile solution containing 250 mg of amikacin sulfate in 1.0 ml of a suitable vehicle.
Preparation Of Sample: 1.0 gm of amikacin sulfate and use directly as test solution 1, dividing it into 2 equal volumes.
Dilute 1 volume of test solution 1 to 25 ml with water and use it as test solution 2.
Amikacin Sulfate Injection
Identity Test : Procedure
To 1 volume of test solution 1
Add slowly 2 ml of anthrone
Bluish-violet color is produced

7. Description : Injection is a sterile solution containing 100 mg of calcium gluconate in 1.0 mil of a suitable
vehicle.
Preparation Of Sample : 10 mg of calcium gluconate in 1 ml of water and use it as the test solution.
Calcium Gluconate Injection
Identity Test : Procedure
Evaporate 1 ml of the test solution to dryness over a water bath
Add 5 mg of 2-naphthol dissolved in about 1 ml of H2so4
Dark blue-green color is produced
And heat in a water bath for 1 minute

8. Description : Each tablet usually contains 25 mg of indomethacin.
Preparation Of Sample: Weigh 1 tablet and calculate the amount equivalent to 0.05 gm of indomethacin.
Grind the tablets, weigh out the above-calculated equivalent amount as a powdered
material and use it directly as the test substance, dividing it into 2 equal parts.
Melting Point : About 162°C
Indomethacin Tablet
Identity Test : Procedure
Mix 1 part of the test substance with 2 ml of water
Add 2 ml of sodium hydroxide
Degradation test:
Discoloration of the test solution usually indicates gross degradation.
Strong yellow color is produced which fades rapidly

9. Description : 20 mg of miconazole nitrate in 1.0 gm of a suitable cream base.
Preparation Of Sample: Weigh an amount equivalent to 0.10 gm of miconazole nitrate and use directly as
the test substance, dividing it into 2 equal parts. Dissolve 1 part of the test substance in sufficient methanol
to produce 50 ml, filter, and use as the test solution.
Melting Point : About 170°C
Miconazole Nitrate Cream
Identity Test : Procedure
To 1 part of the test substance, add 2 ml of sodium hydroxide
And add 20 gm of zinc powder. Boil gently
Degradation test:
Discoloration of the test solution usually indicates gross degradation.
Ammonia is produced which shows an alkaline
moistened pH-indicator paper.

10. Description : Injection is a sterile solution containing 200 mg of cimetidine in 1.0 ml of a suitable vehicle.
Preparation Of Sample: Ampoules equivalent to 0.4 gm and use directly as the test solution.
dividing it into 2 equal volumes.
Cimetidine Injection
Identity Test : Procedure
To 1 ml of the diluted solution from test 2
Add a few drops of potassium iodobismuthate/acetic acid
Degradation test:
Discoloration of the test solution usually indicates gross degradation.
Orange precipitate is produced

11. Description : Contains 100000 IU of nystatin in 1.0 gm of a suitable ointment base.
Preparation Of Sample: Weigh an amount equivalent to 22,000 IU of nystatin, add 25 ml of dimethylformamide
and shake well. Filter, evaporate the filtrate to dryness, and use the residue as the test.
Melting point: About 1124°C.
Nystatin Ointment
Identity Test : Procedure
To 5 mg of the test substance
And add about 2 ml of H2so4
Degradation test:
Discoloration of the test solution usually indicates gross degradation.
Dark violet color is produced.

12. Description : Each packet contain a white crystalline powder composed of :
Preparation Of Sample: Dissolve the contents of 1 packet in 250 ml of
water & use as the test solution.
Melting point: After melting it first change to yellow colour and
odour of burning sugar is precipitate.
Oral Rehydration Salts (Composition A)
Identity Test : Procedure
To 5 ml of the test solution, add 0.5 ml of nitric acid
And add 0.5 ml of silver nitrate
Degradation test:
Discoloration of the test solution usually indicates gross degradation.
White, curdy precipitate is produced
Ingredients Quantity
Glucose, anhydrous 20.0 gm
Sodium Chloride 3.5 gm
Sodium hydrogen
carbonate
2.5 gm
Potassium chloride 1.5 gm

13. Description : Each packet contain a white crystalline powder composed of :
Preparation Of Sample: Dissolve the contents of 1 packet in 250 ml of
water & use as the test solution.
Melting point: After melting it first change to yellow colour and
odour of burning sugar is precipitate.
Oral Rehydration Salts (Composition B)
Identity Test : Procedure
To 5 ml of the test solution, add 0.5 ml of nitric acid
And add 0.5 ml of silver nitrate
Degradation test:
Discoloration of the test solution usually indicates gross degradation.
White, curdy precipitate is produced
Ingredients Quantity
Glucose, anhydrous 20.0 gm
Sodium Chloride 3.5 gm
Sodium citrate dihydrate 2.9 gm
Potassium chloride 1.5 gm

14. Description : Each tablet usually contain 50 mg of phenytoin.
Preparation Of Sample: Weigh 1tablet & calculate the amount 0.08g of phenytoin. Grind the tablets weigh out the
above-calculated equivalent amount as a powdered material and use it directly as the test substance, dividing it into
2 equal parts.
Melting point: About 298°C.
Phenytoin Tablet
Identity Test : Procedure
Test substance placed on a white test plate
And add 2 drop of ammonia & 1 drop of copper(ii) sulfate
Degradation test:
Discoloration of the test solution usually indicates gross degradation.
Pink precipitate is produced

15. Description : Piperazine citrate usually contains equivalent to 500 mg of piperazine hydrate in 5 ml of a
suitable vehicle.
Preparation Of Sample: Use the well-homogenized contents of one container or the equivalent of 0.5 gm of
piperazine hydrate and use directly as the test solution.
Piperazine Citrate
Identity Test : Procedure
To tale test solution & add 3 ml of calcium chloride
No precipitate is produced. Boil the solution
Degradation test:
Discoloration of the test solution usually indicates gross degradation.
White precipitate is produced, soluble in acetic acid

16. THANKS!
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