USHA COLLEGE OF PHARMACY

PHARMACEUTICS-I
(As per to PCI Syllabus)

D.Pharm. IST Year

LAB MANUAL

Prepared by

Dr. Subhendu Mishra, (Principal)

Usha College of Pharmacy, Vill- Dhadkidih, Bada Kakda,

Seraikella-Kharsawan, Jharkhand
Usha College of Pharmacy Lab Manual

INDEX

S.No List of Experiments Page No

1. To prepare Simple syrup 2

2. To prepare 10 ml of paracetmol pediatric elixir. 4

3. To prepare 10ml of calamine lotion 6

4. To prepare the10 ml of piperazine citrate elixir. 8

5. To prepare and dispense10 ml of aqueous iodine 10

solution.
6. To prepare 10 ml of iodine throat paint. 12
7. To prepare the ORS powder. 14
8. To prepare Compound sodium chloride 16
mouthwash.
9. To prepare the zinc starch and talc dusting 18
powder.
10. To prepare and submit 30 ml castor oil emulsion 20
11. To prepare and submit 30 ml cod liver oil 22
emulsion.
12. To prepare and submit 100 gm of sulphur 24
ointment.
13. To prepare and submit 30 gm of sodium alginate 26
gel.
14. To prepare and submit 10 gm of effervescent 28
granules.
15. Demonstration of various stages of tablet 30
manufacturing processes
16. Demonstration of quality control tests and 32
evaluation of common dosage forms viz. tablets.
17. Demonstration of quality control tests and 35
evaluation of common dosage forms viz. Capsule.

18. Demonstration of quality control tests and 37

evaluation of common dosage forms parenteral or
sterile injections

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Usha College of Pharmacy Lab Manual

Experiment No – 1
Object :- To prepare Simple syrup.
.
Requirements :- Sucrose, distilled water ,percolator ,heat source, etc.

Formula:-

S.No Ingradients Official Formula (IP) Quantity to be taken

1. Sucrose 66.7 g 33.35 gm
2. Purified water , 100.0 g 50 gm
sufficient to produce

Principle: Simple syrup (IP) is a concentrated or nearly saturated solution of sucrose in

purified water. According to IP the concentration of sucrose is 66.7% w/w. The solubility of
sugar in water is slow; at such a high concentration. Therefore the solution is heated to increase
the rate of dissolution. If necessary, Methyl paraben at a concentration not higher than 0.15%
may be used as preservative. Simple syrup is sweet in taste and used as vehicle in formulations
containing nauseous bitter substances. Simple syrup as such does not have any medicinal value
but used as vehicle for dispensing the drugs. Sucrose is a disaccharide, which partially
hydrolyzed in to monosaccharide as glucose and fructose. These monosaccharides are called
as invert sugars and reaction is called as inversion.

Procedure: 1) Transfer the weighed amount sucrose in a conical flask.

2) Add sufficient amount of water.
3) Make the syrup by heating or without heat.
4) Macerate it with cold water or heat the solution. It also be
Agitated to accelerate the solubalization.
5)If necessary filter the syrup.
6) Store in a dried container with proper label.

Category : Pharmaceutical aid (sweetening agent or sweet vehicle).

Container: Pack in glass or plastic bottle.

Storage : Syrup should be store in a loosely stopper bottle at fairly cool tem-
perature 0.15% methylparaben may be used as a preservative.

Uses: Pharmaceutical aid as sweetening agents, sweet vehicle and

used as the base for various flavored and medicinal syrups.
.

Label:

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Usha College of Pharmacy Lab Manual

PARACETAMOL PEDIATRIC ELIXIR

10 ml
Composition BATCH NO.

Sucrose MFG. DATE:

Purified water , sufficient to produce
MFG. LIC. NO.:

EXPIRY DATE:
Category: Sweetening agent, vehicle

FOR INTERNAL USE ONLY.

Use: Simple Syrups are used as vehicles for drugs such as antibiotics, Antihistaminic,
antitussives and vitamins.

Storage: Stored in a well closed container at a temperature not exceeding 250C

MFG BY: ABCD Batch: Roll No.:

Experiment No - 2
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Usha College of Pharmacy Lab Manual

Object: To prepare 10 ml of paracetmol pediatric elixir.

Requirements: Beakers, glass rod, measuring cylinder.

Category: Analgesic and antipyretic

Formula:

S.No Ingradients Official Formula (IP) Quantity to be taken

3. Paracetmol 2.4 gm 0.25 gm
4. Ethanol (96%) 10ml 1 ml
5. Propylene glycol 10 ml 1 ml
6. lemon Syrup 10 ml 1 ml
7. Chloroform 2 ml 0.2 ml
8. Invert syrup 30 ml 3 ml
9. Amaranth solution q.s q.s
10. Glycerin q.s to 100 ml 10 ml

Principle:
Elixirs are flavored hydro alcoholic solutions to which glycerin often is added to enhance the
solvent properties. The alcohol which is present in the chloroform spirit act as a preservative.
Paracetamol is unpleasant taste which is masked with the syrup to prevent the unpleasant taste
of elixir. The addition of aqueous solutions to elixirs may cause turbidity or separation by
lessening the alcohol concentration.
Procedure:
1) Dissolve the Paracetamol in the mixture of ethanol and chloroform water.
2) Then add the syrup with continuous stirring and shake it.
3) Finally add the glycerin to make up the final volume.

Dispensing: : Transfer the elixir to a clear or amber colored, narrow mouthed glass bottle, close
it thoroughly with metallic screw cap, polish and label.

Storage: Store in a closed container at a temperature not exceeding 25°C.

Direction: 5-10ml daily in divided doses to be taken in morning and night.

Label:

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Usha College of Pharmacy Lab Manual

PARACETAMOL PEDIATRIC ELIXIR

10 ml
Composition BATCH NO.

Paracetamol MFG. DATE:

Ethanol (96%)
MFG. LIC. NO.:
Propylene glycol
lemon Syrup EXPIRY DATE:

Chloroform
Invert syrup
Amaranth solution
Glycerin
Category: Astringent

FOR INTERNAL USE ONLY

Use: This is used as antipyretic

Storage: Stored in a well closed container at a temperature not exceeding 250C

MFG BY: ABCD Batch: Roll No.:

Experiment No - 3
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Usha College of Pharmacy Lab Manual

Object :- To prepare 10ml of calamine lotion

Requirements: - Calamine, Zinc oxide, Bentonite, Sodium citrate, Liquid phenol, Glycerin.

Apparatus: Mortar and pestle, Measuring cylinder, spatula.

Category: Skin protectant.

Formula:-

S.No Ingradients Official Formula (IP) Quantity to be taken

Calamine 15 gm 1.5 gm
Zinc oxide 5 gm 0.5 gm
Bentonite 3 gm 0.3 gm
Sodium citrate 0.5gm 0.05 gm
Liquid phenol 0.5ml 0.05 gm
Glycerin 5ml 0.5 ml
Purified water q. s. to100 ml q. s. to10 ml

Principle:
Lotions may be used for local action as cooling, smoothing, protective purpose. Calamine and
zinc oxide acts as skin protective and astringent. Calamine is chemically zinc oxide, colored
pink (or) reddish brown containing ferric oxide. It is insoluble and in diffusible in water.
Bentonite is colloidal hydrated aluminum having capacity to absorb water. Sodium citrate acts
as anti-oxidant and buffer phenol (0.2 to 2.5%) acts as antiseptic, preservative and local
anesthetic. Glycerin is humectants after evaporation of water, glycerin holds calamine and zinc
oxide as fine powder on the skin and also increases the viscosity of suspension. Calamine lotion
is used for relief from itching which may be due to allergy or worm infection
Procedure:
1) Calamine, zinc oxide and Bentonite were finely powdered in ascending order of their
weights.
2) Sodium citrate was dissolved in 3/4th volume of purified water.
3) This solution was added to powdered mixture and triturated. Phenol and glycerin were
mixed and then added to calamine mixture.
4) This was transferred into a bottle and final volume was adjusted with purified water and
labeled.

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Usha College of Pharmacy Lab Manual

Dispensing: : Transfer the lotion to a clear or amber colored, narrow mouthed glass bottle,
close it thoroughly with metallic screw cap, polish and label.
Storage: Stored in a well closed container.
Auxiliary label: FOR EXTERNAL USE ONLY, SHAKE WELL BEFORE USE.
Direction: Apply on effected area without friction as directed by physician.

Label:

CALAMINE LOTION
10 ml
Composition BATCH NO.

Calamine MFG. DATE:

Zinc oxide
MFG. LIC. NO.:
Bentonite
Sodium citrate EXPIRY DATE:

Liquid phenol
Glycerin
Purified water
Category: Astringent

FOR EXTERNAL USE ONLY

Use: This is used as astringent

Storage: Stored in a well closed container at a temperature not exceeding 250C

MFG BY: ABCD Batch: Roll No.:

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Usha College of Pharmacy Lab Manual

Experiment No - 4
Object :- To prepare and dispense10 ml of aqueous iodine solution.

Requirements :- Iodine, Potassium iodide, purified water, etc.

Apparatus: Beakers, glass rod, measuring cylinder.

Synonym: Lugol’s solution

Category: Source of iodine in treatment of goiter

Formula:-

S.No Ingradients Official formula (IP) Quantity to be taken

1 Iodine 5 gm 1 gm
2 Potassium iodide 10 gm 2 gm
3 Purified water q.s to 100 ml Up to 20 ml

Principle:
Aqueous iodine solution contains 5%w/v of iodine 10% w/v of potassium iodide. Since, iodine
is sparingly soluble in water; the solubility of iodine is increased by forming complex with
potassium iodide. The complex form is more soluble than iodine in water. Iodine reacts with
potassium iodide and forms complexes as polyiodides. These are highly soluble in water.
Higher polyiodides are more soluble than lower polyiodides.
KI + n I2 → KI.nI2
Potassium iodide Iodine Polyiodides

Procedure:
1) Dissolve potassium iodide in small quantity of water and add iodine to the solution.
2) Stir well to dissolve iodine and make the final volume with water.
Dispensing: : Transfer the solution in to amber colored, narrow mouthed, glass bottle, close
it thoroughly with plastic screw cap, polish and label.
Storage: Store in a cool and dark place
Report:

Note: Goiter is enlargement of the thyroid gland, causing a swelling in the front part of the
neck

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Usha College of Pharmacy Lab Manual

Label:

AQUEOUS IODINE SOLUTION

10 ml
Composition BATCH NO.

Iodine MFG. DATE:

Potassium iodide
MFG. LIC. NO.:
Purified water
EXPIRY DATE:
Category: Antiseptic

FOR EXTERNAL USE ONLY

Use: It is used as an antiseptic

Storage: Stored in a well closed container at a temperature not exceeding 250C

MFG BY: ABCD Batch: Roll No.:

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Usha College of Pharmacy Lab Manual

Experiment No - 5
Object: To prepare 10 ml of iodine throat paint.

Requirements: Motor and Pestle, measuring cylinder, spatula.

Formula:

S.No Ingradients Official Formiula (BPC) Quantity to be taken

Potassium iodide 2.4 gm 0.24 gm
Iodine 1.2 gm 0.12 gm
Alcohol (90%) 4.0 ml 0.4 gm
Purified water 2.4 ml 0.24 gm
Glycerin q.s to 100 ml q.s to 10 ml

Principle:

Iodine is slightly soluble in water, but it is soluble in presence of potassium Iodide and forms
polyiodides. These polyiodides are highly soluble in water and hence produce monophonic
liquid. Alcohol (90%) acts as co solvent, to increase the solubility of iodine. It is also used to
dissolve glycerin is viscous in nature hence Mandl’s paint will remain in contact with mucous
membrane of throat for longer time, it also acts as humectant and soothing agent.

Procedure:

1) Triturate iodine in glass mortar, to get fine powder and accurately weigh the required amount
of iodine.

2) Dissolve potassium iodine in water. To this solution, add iodine powder by stirring.

3)Dissolve the portion of glycerin in alcohol and add this solution to the above iodine and
potassium iodide solution, with continuous stirring and adjust the final volume with remaining
portion of glycerin.

Dispensing:

Mandl’s paint contains volatile ingredients like iodine, alcohol (90%) and iodine is sensitive to
the light. Hence transfer the paint to an amber colored, wide mouthed, glass bottle, close it
tightly with plastic screw cap polish and label. Supply with camel hair brush.

Direction: Apply with camel hair brush, every four hours.

Label: FOR EXTERNAL USE ONLY. SHAKE WELL BEFORE USE.

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Storage: store in a cool and dark place.

Category: Mandl’s paint is used in the treatment of pharyngitis, laryngitis, tonsillitis and sore
throat.

Report:

Note: Expectorants are the drugs that loosen and clear mucus from the respiratory tract.

Lebel:

IODINE THROAT PAINT

10 ml
Composition BATCH NO.

Potassium iodide MFG. DATE:

Iodine
MFG. LIC. NO.:
Alcohol (90%)
Glycerin EXPIRY DATE:

Category: pharyngitis, laryngitis, tonsillitis

and sore throat.

FOR INTERNAL USE ONLY.

Storage: Store in a well closed container and should be kept in a room temperture.

MFG BY: ABCD Batch: Roll No.:

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Experiment No-6

Aim: To prepare the ORS powder

Apparatus: Mortar and pestle, spatula.
Category: Rehydrating salt.
Formula:

S.No Ingradients Official Formula (IP) Quantity to be taken

1. Sodium chloride 0.26 gm 0.26 gm
2. Glucose 1.35 gm 1.35 gm
3. Potassium chloride 0.15 gm 0.15 gm

4. Tri sodium citrate 0.29 gm 0.29 gm

dihydrate

Principle:
Diarrhoea in children usually gets better on its own, it causes loss of water and salts. This may
lead to dehydration, which can be dangerous, especially in very young children, because it is
difficult to see the signs of dehydration. Your child may be dehydrated if they have any of the
following symptoms fewer like child is urinating less often, they are less active than normal, a
dry mouth, crying without tears, a sunken soft spot on the top of a baby’s head. Oral rehydration
salts do not treat the diarrhoea itself, but they replace the salts and water that are lost, and so
reduce the effects of dehydration.
Procedure:-
1. Mix all the ingredients in a mortar and triturated until a fine powder is obtained. This powder
was transferred into white glazed paper (demy paper) and wrapped.
2. Then these wrapped sachets are kept in a paper box and dispensed. Sometime double
wrapping is required, especially if the powder is hygroscopic.
3. In this case waxed paper is used as inner wrapper, then the demy wrapper as the outer
wrapper.
Dispensing: The packed sachets are transferred into wide mouthed bottle tightly closed with
colored plastic screw cap.
Direction: Add one sachet of powder, to a glass of water with stirring and drink the solution.
Storage: Store in a cool and dry place.

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Lebel:

ORS POWDER

Composition BATCH NO.

Sodium chloride MFG. DATE:

Glucose
MFG. LIC. NO.:
Potassium chloride
Tri sodium citrate dihydrate EXPIRY DATE:

Category: Rehydrating salt.

FOR INTERNAL USE ONLY.

Use: Rehydration
Storage: Store in a well closed container and should be kept in a room temperture.

MFG BY: ABCD Batch: Roll No.:

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Usha College of Pharmacy Lab Manual

Experiment No – 7
Object: To prepare Compound sodium chloride mouthwash.

Requirements: Sodium bicarbonate, sodium chloride, concentrated peppermint

Emulsion, double strength chloroform water, purified water etc.

Category: - Antipruritic.

Formula: -

S.No Ingradients Official Formula Quantity to be taken

1. Sodium bicarbonate 1.0 g 1.0 g

2. Sodium chloride 1.5 g 1.5 g

3. Concentrated 2.5 ml 2.5 ml

peppermint emulsion
4. Double strength 50.0 ml 50.0 ml
chloroform water
5. Purified water 100.0 ml 100.0 ml

Procedure: - 1) Dissolve sodium bicarbonate and sodium chloride in purified water.

2) Add concentrated peppermint emulsion and mix.
3) Add double strength chloroform water.
4) Add sufficient purified water to produced 100 ml.

Category: Mouth freshener (antibacterial and astringent).

Storage: Store in a narrow-mouthed, screw-capped, coloured fluted bottle.

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Lebel:

COMPOUND SODIUM CHLORIDE MOUTHWASH

100 ML
Composition BATCH NO.

Sodium bicarbonate MFG. DATE:

Sodium chloride
MFG. LIC. NO.:
Concentrated peppermint emulsion
Double strength chloroform water EXPIRY DATE:

Purified water
Category: Antipruritic

FOR INTERNAL USE ONLY.

Use: Mouth freshener (antibacterial and astringent)
Storage: Store in a well closed container and should be kept in a cool place.

MFG BY: ABCD Batch: Roll No.:

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Experiment No – 8
Aim: To prepare the zinc starch and talc dusting powder.
Apparatus: Mortar and pestle, spatula.
Category: Antiseptic dusting powder.
Formula:

S.No Ingradients Official Formula (IP) Quantity to be taken

1. Zinc oxide 4 gm 2.5 gm
2. Starch 4 gm 2.5 gm
3. Talc 8 gm 5 gm

Principle:
Dusting powder is a sterile cutaneous powder containing starch and purified talc in which the
talc is sterilized before incorporation with the starch, or the final product is subject to a suitable
terminal sterilization procedure. Dusting powders are applied to the skin for a surface effect
such as drying or lubrication. Some dusting powders incorporate medicaments, giving them
antibacterial or Antiseptic action.
Procedure:-
1. Weigh the calculated amounts of Zinc Oxide, Starch and Talc.
2. Transfer the Starch to a porcelain mortar. Add the Zinc Oxide to the Starch in the mortar and
mix using a pestle.
3. Add the Purified Talc to the powders in the mortar and continue mixing. Transfer the mixed
powder to an amber glass jar.
4. Label and dispense to the patient.
Dispensing: Transfer the dusting powder into a re closable perforated plastic container
Direction: Sprinkle lightly on the affected area, two-three times a day.
Storage: Store in a dry place and away from sunlight.
Auxiliary label: FOR EXTERNAL USE ONLY.

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Lebel:

DUSTING POWDER
30gm
Composition BATCH NO.

Zinc oxide MFG. DATE:

Starch
MFG. LIC. NO.:
Talc
EXPIRY DATE:
Category: Antiseptic

FOR EXTERNAL USE ONLY.

Use: Antiseptic
Storage: Store in a well closed container and should be kept in a cool place.

MFG BY: ABCD Batch: Roll No.:

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Experiment No – 9
Aim: To prepare and submit 30ml of Castor oil emulsion.
Requirements:
Apparatus Required:
Mortar & pestle, weigh balance, measuring cylinder, glass rod, spatula, beaker, funnel etc.
Chemical Required: Castor oil and Cinnamon water q. s.
Principle:
An emulsion is a mixture of two or more liquids that are normally immiscible (unmixable or
unblendable) owing to liquid-liquid phase separation. Depending upon the nature of the
dispersed phase, the emulsions are classified as (i) Water-in-oil emulsion (W/O) (ii) oil in water
emulsion (O/W) Liquid paraffin is primarily used as a pediatric laxative in medicine and is a
popular treatment for constipation and encopresis. Castor oil emulsion is used as a laxative, to
empty the GI tract, while the patients is prepared for the colon X –ray, proctoscopy and
endoscopic examination.
Formula:

S.No Ingradients Official Formula (IP) Quantity to be taken

1. Castor oil 20 ml 12 ml

2. Cinnamon water q. s. 50 ml 18 ml

Procedure:
✓ Weigh calculated quantity of acacia is take in a mortar.
✓ Measured quantity of cinnamon water at once (calculated for primary emulsion formula)
is added into the mortar.
✓ The content, in the mortar is triturated to form mucilage.
✓ Measured quantity of castor oil is added in small quantities, with constant, rapid and light
trituration to produce a thick cream. Trituration is continued for three minutes to obtain a
white stable emulsion. It is indicated by click sound.
✓ Some more quantity of cinnamon water is added gradually with continuous trituration.
✓ The contents are transferred into a measuring cylinder.

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✓ The pestle and mortar are rinsed with cinnamon water and rinsing are transferred into the
measuring cylinder.
✓ The quantity is adjusted to the required volume using cinnamon water and the contents
are stirred well.
✓ The castor oil emulsion is then transferred into a wide mouthed light resistant container.
✓ The bottle is capped, labelled, polished and submitted.

Use: Castor oil emulsion is used as a laxative, to empty the GI tract, while the patients is
prepared for the colon X –ray, protoscopy and endoscopic examination.
Storage: It should be store in a tightly –closed container in a cool place.
Category: Laxative.
Dose: 4 -6 ml
Direction: Take on an empty stomach followed with one full glass of water.

Label:
CASTOR OIL EMULSION
30 ML
Composition BATCH NO.

Castor oil MFG. DATE:

Cinnamon water q. s.
MFG. LIC. NO.:

EXPIRY DATE:
Category: Laxative

FOR INTERNAL USE ONLY.

Use: Castor oil emulsion is used as a laxative, to empty the GI tract, while the patients are
prepared for the colon X –ray, protoscopy and endoscopic examination.
Storage: It should be store in a tightly –closed container in a cool place.

MFG BY: ABCD Batch: Roll No.:

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Experiment No – 10

Aim: To prepare and submit 30ml of Cod Liver Oil emulsion.

Requirements:
Apparatus Required:
Mortar & pestle, weigh balance, measuring cylinder, glass rod, spatula, beaker, funnel etc.
Chemical Required: Cod liver oil, Egg yolk, Purified water q.s
Principle:
An emulsion is a mixture of two or more liquids that are normally immiscible (unmixable or
unblendable) owing to liquid-liquid phase separation. Depending upon the nature of the
dispersed phase, the emulsions are classified as (i) Water-in-oil emulsion (W/O) (ii) oil in
water emulsion (O/W).
Cod liver oil is a rich sources of vitamin D and therefore used as an anti-rachitic agent.
Formula:
S.No Ingradients Official Formula (IP) Quantity to be taken

1. Cod liver oil 30 ml 15 ml

2. Egg yolk 4 ml 2 ml

3. water q. s 60ml 30 ml

Procedure:
✓ Egg yolk is separated from the broken egg and placed in a measure. Equal volume of
water is added and mixed thoroughly.
✓ The calculated volume of the above egg yolk is placed in a mortar.
✓ The calculated volume of cod liver oil is added to the mortar and mixed with constant
stirring.
✓ Purified water (1/3rd the total quantity0 is gradually added with constant trituration.
✓ The mixture is strained through a muslin cloth.
✓ Mortar and pestle are rinsed with little volume of water and transferred through the
muslin cloth.
✓ The volume is adjusted to the required level with water in a measuring cylinder.
✓ The contents are mixed well and transferred into a narrow-mouthed container
✓ The container is capped, polished, labelled and dispensed.
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Use: It is used as an Anti-rachitic agent (in deficiency of vitamin D).

Storage: It should be store in a tightly well closed container in a cool place.
Category: Anti-rachitic (in deficiency of vitamin D)
Dose: Not more than 10ml daily.

Label:
CORD LIVER OIL EMULSION
30 ML
Composition BATCH NO.

Cod liver oil MFG. DATE:

Egg yolk
MFG. LIC. NO.:
water q. s
EXPIRY DATE:
Category: Anti-rachitic (in deficiency of
vitamin D)
FOR INTERNAL USE ONLY.
Use: It is used as an Anti-rachitic agent (in deficiency of vitamin D)

Storage: It should be store in a tightly well closed container in a cool place.

MFG BY: ABCD Batch: Roll No.:

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Experiment No – 11

Aim: To prepare and submit 100gm of Simple ointment.

Requirements:
Apparatus Required:
Mortar & pestle, weigh balance, measuring cylinder, glass rod, spatula, beaker, ointments slab
etc.
Chemical Required:
Wool fat, hard paraffin, white soft paraffin, cetostearyl alcohol.
Principle:
Ointments are semisolid preparation meant for external application to the skin or mucous
membrane. They usually contain medicament or medicaments which are dissolved or
dispensed or suspended or emulsified as an antiseptic, antifungal agent.
Formula:
S.No Ingradients Official Formula (IP) Quantity to be taken

1. Wool fat 5 gm 5 gm

2. Hard paraffin 5 gm 5 gm

3. Cetostearyl 5 gm 5 gm
alcohol
4. White soft 85 gm 85 gm
paraffin

Procedure:
✓ Melt hard paraffin and Cetostearyl alcohol on water bath.
✓ To this incorporate wool fat and white soft paraffin.
✓ Stir until all ingredients are melted.
✓ Examine the contents for any foreign particles. Decant or strain if required.
✓ Stir the mixture thoroughly until cold.
✓ Pack it in an ointment jar, label, and dispense.

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Direction: Apply as directed.

Use: This are used to treat seborrheic dermatitis and scabies.
Storage: Keep in well closed container and cool place.

Label:

SIMPLE OINTMENT
100gm
Composition BATCH NO.

Wool fat MFG. DATE:

Hard paraffin
MFG. LIC. NO.:
Cetostearyl alcohol
White soft paraffin EXPIRY DATE:

Category: Anti-Acne

FOR INTERNAL USE ONLY.

Use: This are used to treat acne and also used to treat seborrheic dermatitis and scabies.

Storage: Stored in a well closed container dark and cool place and temperature not exceeding
250C

MFG BY: ABCD Batch: Roll No.:

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Experiment No – 12

Aim: To prepare and submit 100gm of Sulphur ointment I.P.

Requirements:
Apparatus Required:
Mortar & pestle, weigh balance, measuring cylinder, glass rod, spatula, beaker, ointments
slab etc.
Chemical Required:
Sublimed Sulphur, wool fat, hard paraffin, white soft paraffin, Cetostearyl alcohol.
Principle:
Ointments are semisolid preparation meant for external application to the skin or mucous
membrane. They usually contain medicament or medicaments which are dissolved or
dispensed or suspended or emulsified as an antiseptic, antifungal agents and Sulphur ointment
used to treat different skin infections.
Formula:
Preparation of ointment base:
S.No Ingradients Official Formula (IP) Quantity to be taken

1. Wool fat 5 gm 5 gm

2. Hard paraffin 5 gm 5 gm

3. Cetostearyl 5 gm 5 gm
alcohol
4. White soft 85 gm 85 gm
paraffin

S.No Ingradients Official Formula (IP) Quantity to be taken

1. Sublimed Sulphur 10 gm 10 gm

2. Simple ointment 90 gm 90 gm

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Procedure:
Preparation of simple ointment:
✓ Required quantity of hard paraffin and Cetostearyl alcohol.
✓ Wool fat and white soft paraffin were incorporated and stirred until all ingredients were
melted.
✓ The mixture was stirred thoroughly until cooled.

Preparation of Sulphur ointment:

Sublimed Sulphur was triturated and finely shifted through sieve no.85. Required quantity of
Sulphur was taken on ointment base and mix small amount of ointment of simple ointment was
gradually added until homogeneous mass was obtained.
Direction: Apply as directed.
Use:
✓ This are used to treat acne Sulfur ointment.
✓ This are used to treat seborrheric dermatitis and scabies.

Storage: Keep in well closed container and cool place.

Label:
SULPHUR OINTMENT I.P
100gm
Composition BATCH NO.

Wool fat MFG. DATE:

Hard paraffin
MFG. LIC. NO.:
Cetostearyl alcohol
White soft paraffin EXPIRY DATE:

Category: Anti-Acne

FOR INTERNAL USE ONLY.

Use: This are used to treat acne Sulphur ointment and also used to treat seborrheric
dermatitis and scabies.
Storage: Stored in a well closed container dark and cool place and temperature not
exceeding 250C
MFG BY: ABCD Batch: Roll No.:

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Experiment No – 13
Aim: To prepare and submit 30gm of Sodium alginate gel.
Requirements:
Apparatus Required:
Mortar & pestle, weigh balance, measuring cylinder, glass rod, spatula, beaker etc.
Chemical Required:
Sodium alginate, Calcium chloride, Coloring agent, purified water
Principle:
A gel is a semi-solid that can have properties ranging from soft and weak to hard and tough.
Gels are defined as a substantially dilute cross-linked system, which exhibits no flow when in
the steady- state. A gel has been defined phenomenologically as a soft, solid or solid-like
material consisting of two or more components, one of which is a liquid, present in substantial
quantity.
Formula:
S.No Ingradients Official Formula (IP) Quantity to be taken

1. Sodium alginate 2%w/v

2. Calcium chloride 5%w/v

3. Coloring agent q. s

4. Purified water 100ml

Procedure:
Step 1: Mix the dry, powdered sodium alginate with distilled water.
For a great gel, use 100 ml of distilled water and 1 teaspoon of sodium alginate (this is a 2%
sodium alginate solution).
Step 2: In another container, mix the calcium chloride with distilled water.
Use a heaping teaspoon of calcium chloride in 100 ml of distilled water (this is a 5% calcium
chloride solution)
Step 3: Make a gel by adding dissolved alginate to the calcium solution.
Using a spoon or a dropper, add (i.e., drop or squirt) a little of the sodium alginate solution into
the calcium chloride solution. In an instant, the calcium reacts with the sugar units in the
alginate to pull the long flexible chains of alginate into a gel.

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Use: Alginate is used as an emulsifier or stabilizer.

Storage: It should be tightly closed and stored out of contact with water.
Label:
SODIUM ALGINATE GEL
30 gm
Composition BATCH NO.

Sodium alginate MFG. DATE:

Calcium chloride
MFG. LIC. NO.:
Colouring agent
Purified water EXPIRY DATE:

Category: Stabilizing

FOR EXTERNAL USE ONLY.

Use: used as an emulsifying, stabilizing, suspending, thickening agent.

Storage: Stored in a well closed container at a temperature not exceeding 250C It should
be tightly closed and stored out of contact with water
MFG BY: ABCD Batch: Roll No.:

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Experiment No – 14

Aim: To prepare and submit 10gm of Effervescent granules.

Requirements:
Apparatus Required:
Mortar & pestle, weigh balance sieve shaker, China dish etc.
Chemical Required:
Sodium phosphate, sodium bicarbonate, tartaric acid.
Principle:
Effervescent preparation provides effervescence of CO2 gas when added to water by a
chemical reaction between alkali metal carbonates or bicarbonates with tartaric acid or citric
acid. This preparation is intended to be dissolved in water before it is being taken orally. The
CO2 gas is released as a result of acid-base reaction. The preparation is advised to be taken
while effervescence.
Formula:
S.No Ingradients Official Formula (IP) Quantity to be taken

1. Sodium phosphate 1.1 gm 2.2 gm

2. Sodium bicarbonate 2.1 gm 4.2 gm

3. Tartaric acid 1.1 gm 2.2 gm

4. Citric acid 0.7 gm 1.4 gm

Procedure:
✓ Citric acid is mixed with sodium phosphate and tartaric acid.
✓ Add sodium bicarbonate to the above mixture and mix it gently.
✓ The final powdered mixture is placed in a China dish previously heated on water bath.
✓ Stir the mixture with the help of a spatula constantly still it becomes damp mass.
✓ Pass damp mass through sieve number 8.
✓ Dry granules at a room temperature not exceeding 540C.
✓ Pass dry granules through appropriate sieve.
✓ Pack dry uniform sized granules in a wide mouthed bottle.

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Dose: Each 5g contains sodium phosphate 1g.

Storage: Stored in air tight container in a cool place,
Use: Saline purgative and mild diuretic.
Label:

EFFERVESCENT GRANULES
10gm
Composition BATCH NO.

Sodium phosphate MFG. DATE:

Sodium bicarbonate
MFG. LIC. NO.:
Tartaric acid
Citric acid EXPIRY DATE:

Category: Saline purgative and Mild

diuretic

FOR INTERNAL USE ONLY.

Use: Saline purgative and Mild diuretic

Storage: Stored in a well closed air tight container in a cool place and temperature not
exceeding 250C
MFG BY: ABCD Batch: Roll No.:

Experiment No – 15
Aim: Demonstration of various stages of tablet manufacturing processes

Process: The manufacturing of tablets involves numerous unit processes, including:

✓ Particle size reduction and sizing
✓ Blending
✓ Granulation
✓ Drying

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✓ Compaction
✓ Testing of physical properties
✓ Coating
Sizing: Sizing (size reduction, milling, crushing, grinding, pulverization) is an important step
in the process of tablet manufacturing.
In the manufacturing of compressed tablets, the mixing or blending of several solid
pharmaceutical ingredients is easier and more uniform if the ingredients are about the same
size. This provides greater uniformity of dose. Fine particle size is essential in the case of
lubricant mixing with granules for its proper function.
Various types of machines may be used for the dry sizing or milling process, depending on
whether gentle screening or particle milling is needed. The range of equipment employed for
this process includes:
✓ Fluid energy mill
✓ Colloidal mill
✓ Ball mill
✓ Hammer mill
✓ Cutting mill
✓ Roller mill
✓ Conical mill
Blending:
The successful mixing of powder is more difficult than mixing liquid, as perfect homogeneity
is difficult to achieve. Another problem is the inherent cohesiveness and resistance to
movement between the individual particles. The process is further complicated in many
systems by the presence of substantial segregation influencing the powder mix. This arises
from the difference in size, shape, and density of the component particles.
The powder/granules may be blended at the pre-granulation and/or post-granulation stage of
tablet manufacturing. Each process of mixing has an optimum mixing time, and longer mixing
may result in an undesired product. The optimum mixing time and speed must be evaluated.
Blending prior to compression is normally achieved in a simple tumble blender. This be a fixed
blender into which the powders are charged, blended and discharged. It is now common to use
a bin blender from which the container (bin) can be removed and brought directly to other
processing steps.

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In special cases of mixing a lubricant, overmixing should be particularly monitored. The

various blenders used include the “V” blender, oblicone blender, container blender, tumbling
blender, and agitated powder blender.
Granulation:
Following particle size reduction and blending, the formulation may be granulated, which
provides homogeneity of drug distribution in the blend. This process is very important and
needs the experience to attain the proper quality of granules before tabletting. The quality of
granules determines the smooth and trouble-free process of tablet manufacturing. If granulation
is not done in a proper manner, the resulting mixture may damage the tabletting press.
Drying:
Drying is an important step in the formulation and development of a pharmaceutical product.
It is important to keep the residual moisture low enough to prevent product deterioration and
ensure free-flowing properties. The commonly used dryers include the fluidized-bed dryer,
vacuum tray dryer, microwave dryer, spray dryer, freeze dryer, turbo-tray dryer, and pan dryer.
Tablet compression:
1. Top punch is withdrawn from the die by the upper cam. The bottom punch is low in the die
so powder falls in through the hole and fills the die.
2. The bottom punch moves up to adjust the powder weight. It raises and expels some powder.
3. Top punch is driven into the die by the upper cam. The bottom punch is raised by the lower
cam. Both punch heads pass between heavy rollers to compress the powder.
4. Top punch is withdrawn by the upper cam. A lower punch is pushed up and expels the
tablet, which is removed from the die surface by a surface plate.
5. Return to stage 1.

Experiment No – 16
Aim: Demonstration of quality control tests and evaluation of common dosage forms viz.
tablets.
Theory:
Tablets are the solid unit dosage forms, which are the most popular, convenient and widely
used pharmaceutical dosage forms attributing to the number of advantages offered to the
patients. Tablets may be evaluated for their physical characteristics, drug contents, rate of
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release of drugs etc. Certain physical properties of drugs like the uniformity of weight, hardness
friability, thickness, disintegration and dissolution times are important characteristics having a
bearing on their handling and use.
General appearance:
It is the visual identity and overall elegance that is essential for consumer acceptance. This
includes size, shape and thickness, which are important parameters to facilitate packaging and
to decide which tablet compressing, machine to use. Organoleptic properties include colour
and odour of the tablets. Colour of the tablet is important because it affects rapid identification
of the medication, and odour is important to identify any stability problems. An example is
aspirin, which gives the odour of acetic acid if any stability problem occurred.
Weight uniformity:
It is desirable that every individual tablet in a batch is uniform in weight and the weight
variation if any is within the permissible limits as is given in the official pharmacopoeias of
each country. The test of uniformity of weight is carried out by collecting a sample of tablets,
normally 20, from a batch and determining their individual weights. The average weight of the
tablet is then calculated. The sample complies with the standard if the individual weights do
not deviate from the mean more than is permitted in terms of percentage. The weight variation
tolerances for uncoated tablets as per IP, BP and USP are given in Table 1.
Table 1: Tablet weight variation limits as per IP, BP, and USP
Average weight of tablets (mg) Maximum percentage difference allowed
As per IP and BP
80 or less 10
80-250 7.5
More than 250 5
As per USP-NF
130 or less 10
130-324 7.5
More than 324 5

Hardness:
The hardness of a tablet is indicative of its tensile strength and is measured in terms of
load/pressure required to crush it when placed on its edge. Hardness of the tablet is a non-
official still very important test for tablet evaluation as the hardness has direct impact on the

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disintegration properties of the tablet. A number of hardness testers namely Pfizer, Erveka,
Monsanto, Strong Cobb and Schleuniger are currently in use. Hardness of about 5 KiloPascals
is considered to be minimum for uncoated tablets.
Thickness:
The thickness of the tablet mainly depends on the die filling, physical properties of materials,
to be compressed and compressional forces. The thickness is measured by a vernier caliper and
it should not vary beyond 5 % of the standard value.
Friability:
Tablet hardness is not an absolute indicator of the tablet strength since some formulations when
compressed into very hard tablets tend to “cap” on attrition losing their crown portions.
Therefore, another measure of the tablet strength, its friability is often measured. The
laboratory friability tester is known as the Roche’s friabilator. This device subjects a number
of tablets to the combined effects of abrasion and shock by utilizing a plastic chamber that
revolves at 25 rpm dropping the tablets a distance of six inches with each revolution. Normally,
a pre-weighed tablet sample is placed in the friabilator, which is then operated for 100
revolutions. The tablets are then dedusted and reweighed. Conventional compressed tablets
that lose less than 0.5-1% of their weight are generally considered acceptable. The limit as
given in the USP is given in Table 2.
Table 2: Tablet weight to be taken for friability test
Tablet in weight Overall weight to be taken for friability
testing
Equal to or less than 650 mg 6.5g
More than 650 mg 10 tablets

Disintegration:
It is the time required for the tablet to break into particles. The disintegration test is a measure
only of the time required under a given set of conditions for a group of tablets to disintegrate
into particles. In the present disintegration test, the particles are those that will pass through a
10-mesh screen. Complete disintegration occurs when no residue of the tablet is still present
on the screen except the insoluble ingredients as the shell or the coat of the tablet.

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Liquids used in disintegration: Water, simulated gastric fluid (pH = 1.2 HCl), or Simulated
intestinal fluid (pH = 7.5, phosphate buffer + pancreatic enzyme).
Table 3: Disintegration test limits for uncoated tablets as per IP, USP
Medium Temperature Time limit
According to U.S.P Simulated gastric 370 C Not exceed 30 min
fluid
According to B.P. Water 370 C Not exceed 15 min

Experiment No – 17

Aim: Demonstration of quality control tests and evaluation of Capsules.

Theory:
Capsules equal the tablets in their popularity and usage. They are convenient means of
dispersing a variety of solids, semi solids and liquids. All capsules basically consist of a soluble

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shell of a material most common of which is gelatin. The solid substances are dispensed in hard
capsules while for dispensation of semi-solids and liquids, soft gelatin capsules are preferred.
Uniformity of weight:
This test is done by weighing 20 capsules individually, determining average weight per capsule
and finding out weight variation of each capsule against the average value. As per the common
standards specified in IP and BP, net weight of not more than two capsules should differ by
more than ±10% from the average net weight and no capsule should differ by more than ±25%.
If the average weight of 2-6 capsules deviates by ±10% to ±25%, net weight of 40 more
capsules should be determined. In a total of 60 capsules not more than six should deviate from
average by more than ±10% and none by more than ±25%.
Drug content uniformity:
The test is done to assure uniform distribution of medicament. Non-uniform drug distribution
is a difficulty with potent medicines that are administered in low doses. Hence a number of
capsules are specified in the pharmacopoeias which should be selected and assayed for drug
content individually. Pharmacopoeias specify 30 capsules out of which 10 should be assayed
individually in the first instance. Out of these at least, 9 should be within ±15% of average and
none should be beyond ±25%. If 1-3 capsules out of the 10 assayed fall outside ±15%, the
remaining 20 should be assayed. Out of the total of 30 capsules, at least 27 should be within
±15% and no capsule should be beyond ±25% (BP, 2007).
Disintegration:
Disintegration is the state in which no residue except fragments of capsule shell, remains on
the screen of the test apparatus or adheres to the lower surface of the disc. The capsules
disintegrate within a prescribed time when placed in a liquid medium under the prescribed
experimental conditions.
Method:
According to the B.P. and as applied to hard and soft capsules,
a) Introduce one capsule into each tube and suspend the apparatus in a beaker containing
600 ml water at 370 C.
b) If hard capsules float on the surface of the water, the discs may be added.
c) Operate the apparatus for 30 minutes; remove the assembly from the liquid.
d) The capsules pass the test if
e) No residue remains on the screen of the apparatus or,
f) If a residue remains, it consists of fragments of shell or,
g) Is a soft mass with no palpable core?
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h) If the disc is used, any residue remaining on its lower surface should only consist of
fragments of shell.

Experiment No – 18

Aim: Demonstration of quality control tests and evaluation of Parenterals/ Injectable Dosage
Forms.
Theory:
Parenterals (literally meaning ‘aside from the gastrointestinal tract’) are systems, which are
taken into the body or administered in a manner other than through the digestive tract, as by
intravenous or intramuscular injection. All the parenterals since are to be taken directly into
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systemic (blood) circulation are required to be sterile and completely free from pyrogens or
any other external living or non- living substances.
Sterility test:
All parenterals are required to be sterile or free from living microbes, so they ought to be tested
for sterility. The fundamental principle of all sterility tests is to transfer the material under test
aseptically to sterile nutrient media and see whether the media shows any microbial growth
after suitable periods of incubation at optimum temperatures. The entire operation of opening
the container, picking up aliquot portions of the material under test, and its transfer to sterile
media should be carried out under aseptic condition, taking care at every step that no microbe
from external sources gets accidental access to the material under test or the media.
Leaker test:
The containers of parenteral products should be hermetically sealed and there should not be
any contact of their contents and the environment. The leakage tests should be capable of
differentiating between perfectly sealed containers and the leaking ones. Sealed containers are
dipped in coloured solutions and negative pressure is induced. Release of vacuum will force
the coloured solution into the inside of the imperfectly sealed ampoules and such ampoules
would show colour in the final check.
Clarity tests:
Contamination of the parenteral products with solid particles, fibers etc. could be dangerous
especially if the contaminants are larger than the size of the blood cell. USP states that all the
parenteral containers be visually inspected and that any with visible particles be discarded. The
USP test consists of filtering a specified volume of the product through filters with an average
pore size of 8µ followed by microscopic examination of the filter disc. Following the test many
image analysis devices are used to check the clarity. Other devices can be employed to detect
particulate contamination and are based on light absorption, light scattering or change in
electrical resistance. Coulter counter is an example of an instrument based on electrical
resistance. Other parenteral products consisting of small number of single or multiple dose
packaging can be evaluated for clarity manually by interposing them between source of strong
light and the eye.
Pyrogen test:
Pyrogen test should be run on all aqueous parenteral products. The recommended test consists
of injecting suitable amounts of the product into the ear vein of rabbits and recording their fever
response. If rabbits show no rise in body temperature the product can be assumed to be pyrogen
free. Usually, a number of rabbits are used for each test and observations averaged out. The
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initial body temperatures of the animals are measured manually. The pyrogen test is usually
run on vehicles alone since the drugs present in the formulation may interfere in the fever
responses.

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