GP Manual
GP Manual
LABORATORY
MANUAL
Pharmaceutics-I
Prepared By
Sudhanshu Mishra
Simple Syrup IP
Experiment 1
Formula:
Sucrose (sugar) 667 g
Purified water, qs 1000 g
Formula:
Chloroform 2.5 ml
Purified water, qs 1000 ml
1 Chloroform 2.5 ml
Calculation:
1000 ml chloroform water IP contains 2.5 ml chloroform
1 ml chloroform water IP contains will contain 2.5/1000 ml chloroform
50 ml chloroform water IP contains will contain (2.5/1000)*50 ml chloroform
Procedure: Depending on the quantity of preparation to be submitted, the working formula is
calculated.
1. Add chloroform to purified water.
2. Shake frequently until chloroform dissolves in the purified water.
Dose: 15 to 30 ml.
Uses: Chloroform water is used as a pharmaceutical aid. Since it has flavouring, sweetening and
preservative properties so it is used as vehicle in certain preparations meant for internal use and
as menstruum for extraction of drugs.
Chloroform Spirit IP
Experiment- 3
Theory: Inhalation of chloroform causes anaesthesia. When chloroform is exposed to air and
light, oxidation take place but the presence of alcohol in chloroform spirit retards the oxidation.
Formula:
Chloroform 50 ml
Alcohol, 90% qs 1000 ml
Storage: Store in a well-closed glass container in a cool place to prevent the volatilization of
volatile ingredients.
Theory: The solubility of camphor is only 1:700 in water but it is freely soluble in alcohol i.e. 1
part of alcohol. In camphor water, the strength of camphor is 1:1000 that is near to saturation.
Since camphor is very soluble in alcohol, so water is prepared by dissolving the camphor in
alcohol and then this solution is added in small quantities to water with vigorous shaking after
each addition. The addition of alcoholic solution to water yields a finely divided precipitates of
camphor which redissolves easily on shaking.
Water should not be added to the alcoholic solution of camphor because in that case whole of the
camphor will be precipitated out which will not redissolve easily on shaking.
Camphor is volatile in nature so camphor water should be stored in a well-closed container to
prevent the volatilization of camphor.
Formula:
Camphor 1g
Alcohol, 90% 2 ml
Purified water, qs 1000 ml
1 Camphor 1 gm
2 Alcohol, 90% 2 ml
Calculation:
Calculation for camphor:
1000 ml of camphor water IP contains 1 gm of camphor
1 ml of camphor water IP will contains 1/1000 gm of camphor
50 ml of...................................................... (1/1000)*50 gm of camphor
Calculation for ethyl alcohol:
Procedure: Depending on the quantity of preparation to be submitted, the working formula is
calculated.
1. Dissolve the camphor in alcohol 90%.
2. Add the solution in successive portions to the purified water.
3. Shake well after each addition.
4. Afterwards shake occasionally until all the camphor is dissolved.
Category: Pharmaceutical aid.
Dose: 15 to 30 ml.
Uses: Carminative, vehicle for liquid preparations due to its flavouring properties.
Peppermint Spirit BPC
Experiment No. 5
Theory: Official peppermint spirit is prepared by solution with maceration process but
peppermint spirit BC is prepared by solution method in which peppermint oil is dissolved in
alcohol.
Peppermint oil is obtained by distillation from the fresh flowering tops of Mentha piperita family
Labiatae.
Formula:
Peppermint oil 100 ml
Alcohol, 90% qs 1000 ml
Storage: Store in a well-closed container in a cool place to prevent the volatilization of volatile
ingredients.
Theory: Paracetamol paediatric elixir is used as analgesic and antipyretic for children.
Paracetamol is sparingly soluble in water and freely soluble in alcohol. Therefore, alcohol is used
to dissolve the drug. Propylene glycol acts as a co-solvent to increase the solubility. Glycerine
acts as the vehicle and also increases the viscosity of the preparation. It is miscible with alcohol,
propylene glycol, and invert syrup. Chloroform spirit acts as a preservative. Concentrated
raspberry juice acts as flavouring agent. Amaranth solution acts as a colouring agent (for red
colour).
Paracetamol possesses bitter taste. Therefore, invert syrup is used as a sweetening agent to mask
the taste of the drug. However, chloroform spirit, concentrated raspberry juice, and glycerine
also help in masking the taste of the drug. In this case, simple syrup cannot be used as a
sweetening agent/vehicle, because sucrose is insoluble in alcohol.
Formula: Paracetamol 24 g
Amaranth solution 2 ml
Chloroform spirit 20 ml
Concentrated raspberry juice 25 ml
Alcohol 95% 100 ml
Propylene glycol 100 ml
Invert syrup 275 ml
Glycerine qs 1000 ml
Auxiliary Label: The elixir should not be used for longer period.
Aqueous Iodine Solution IP
Experiment No. 07
Theory: aqueous iodine solution is used to supplement iodine in iodine deficiency conditions
like goitre. To treat the patient, iodine is supplied in solution form in a concentration of 50
mg/ml.
Iodine is very slightly soluble in water. Hence, potassium iodide is added to increase the
solubility of iodine. Complexation reaction between potassium iodide and iodine takes place to
form polyiodide complexes as shown below:
𝐾𝐼 + 𝑛 𝐼2 → 𝐾𝐼. 2𝐼2 + 𝐾𝐼. 3𝐼2 … … … … + 𝐾𝐼. 𝑛𝐼2
Polyiodides are easily soluble in water by ion induced dipolar interaction. Higher polyiodides are
more soluble than lower polyiodides. Higher polyiodides are produced in a concentrated
solution. Therefore, iodine and potassium iodide are dissolved first in small quantity of water.
Then, the preparation can be easily diluted to required volume. In making iodine solutions,
potassium iodide may be replaced by sodium iodide.
Since iodine (present in iodine solutions) reacts with some ingredients of ordinary glass
container, iodine resistant container like amber coloured container is used to store iodine
solutions.
Formula:
Iodine 50 g
Potassium iodide 100 g
Purified water qs 1000 mL
1 Iodine 50 gm 10 gm
Calculation:
Calculation for iodine:
1000 ml of aqueous iodine solution contains 50 gm.
1 ml of aqueous iodine solution will contain 50/1000 gm.
20 ml of aqueous iodine solution will contain (50/1000)* 20 gm
Advice to Patients: The solution should be taken by mixing the contents with water or milk.
When used prior to thyroidectomy, the prescribed course (i.e. number of doses) should be
completed.
Precaution: Iodine preparations should not be administered during pregnancy and lactation.
These interfere with tests for thyroid function. Some patients show skin sensitivity to iodine.
Weak Iodine Solution IP
Experiment No. 08
Theory: Weak iodine solution is used internally in hypothyroidism and externally as antiseptic
to treat wounds. In this preparation, the concentration of iodine required is 20 mg/ml.
As this preparation is used internally as well as externally, alcohol 50% (absolute alcohol 50 ml
+ water 50 ml) is used as a vehicle. Iodine is very slightly soluble in water. Its solubility can be
increased by adding potassium iodide. Potassium iodide reacts with iodine to form polyiodides
that are more soluble in alcohol 50%.
𝐾𝐼 + 𝑛 𝐼2 → 𝐾𝐼. 2𝐼2 + 𝐾𝐼. 3𝐼2 … … … … + 𝐾𝐼. 𝑛𝐼2
Polyiodides are more soluble in water by ion induced dipolar interaction. Alcohol is used in this
preparation because of two reasons; (a) when this preparation is applied to the wounds, alcohol
precipitates the proteins and forms a protective layer; and (b) alcohol absorbs heat from the body
and gets evaporated thereby causing cooling effect.
Since iodine (present in iodine solutions) reacts with some ingredients of ordinary glass
container, iodine resistant container like amber coloured container is used to store iodine
solutions.
Formula:
Iodine 20 g
Potassium iodide 25 g
Alcohol, 50%, qs 1000 ml
Category: Antiseptic
Dose: 0.3 to 2 ml.
Advice to Patients: When used in the treatment of cuts and grazes (slight abrasion/scratch) it
should be applied to the skin undiluted. Dressing should not be applied. The solution stains the
skin, hair, and fabric. Stains may be removed with dilute alkali solution or sodium thiosulphate
solution.
Strong Iodine Solution IP
Experiment No. 09
Theory: Strong iodine solution is used externally as an antiseptic in treating wounds. The
concentration of iodine needed in this solution is high (100 mg/ml) compared to aqueous and
weak iodine solutions.
Iodine is very slightly soluble in water. Higher solubility is achieved by converting insoluble
iodine into soluble polyiodides by reacting with potassium iodide.
𝐾𝐼 + 𝑛 𝐼2 → 𝐾𝐼. 2𝐼2 + 𝐾𝐼. 3𝐼2 … … … … + 𝐾𝐼. 𝑛𝐼2
Polyiodides are easily soluble in water by ion induced dipolar interaction. Higher polyiodides are
more soluble than lower polyiodides. Higher polyiodides are produced in a concentrated
solution. Therefore, iodine and potassium iodide are dissolved in water. Then the preparation can
be easily diluted to required volume with alcohol.
Alcohol is used as the diluents, because it quickly evaporates when the solution is painted on the
skin. It dissolves the cutaneous fat thereby hastens penetration and absorption.
Since iodine (present in iodine solutions) reacts with some ingredients of ordinary glass
container, iodine resistant container like amber coloured container is used to store iodine
solutions.
Category: Antiseptic.
Storage: Store in a tightly closed container in a cool place.
Object: To prepare and submit 100 ml of Sodium chloride solution BPC 1968.
Theory: Sodium chloride solution (0.9% w/v) is also known as normal saline solution which is
used to make the preparation isotonic with blood serum, that is, the solution has the same
osmotic pressure as blood serum, and therefore readily diffuses through the walls of small
arteries, veins, and capillaries without causing dilation or collapse. Similarly the blood
corpuscles are unaffected. Sometimes sodium chloride solution is also used as irrigation fluid.
Formula:
Sodium chloride 9g
Purified water qs 1000 ml
Note: If a solution is issued sterile, it should be prepared under sterile conditions. After
preparation and filtration it should be transferred to the final container, which is then closed and
sterilized and autoclaving.
Magnesium Hydroxide Mixture BP
Experiment No. 11
Theory: Milk of magnesia is used as antacid and laxative. According to its usage, the dose
changes. It is a suspension of magnesium hydroxide in water. It is also sometimes called as a
mixture. Mixture is a general term used to indicate the preparations for oral administration.
Magnesium hydroxide mixture BP contains an aqueous suspension of hydrated magnesium oxide
containing not less than 7.0% w/w and not more than 8.5% w/w of magnesium hydroxide. It
cannot be directly prepared by suspending magnesium hydroxide in water. Magnesium
hydroxide is prepared in situ using magnesium sulphate, sodium hydroxide, and light magnesium
oxide. These are exothermic reactions (heat is liberated) and are explained s follows:
Double decomposition reaction
MgSO4 + 2NaOH Mg (OH)2 + Na2SO4
Magnesium Sodium Magnesium Sodium
sulphate hydroxide hydroxide sulphate
Transluscent
gelatinous
precipitate
Hydration reaction
MgO + H2O Mg (OH)2
Magnesium Water Magnesium
oxide hydroxide
Magnesium hydroxide prepared from magnesium sulphate is gelatinous in nature, whereas
magnesium hydroxide prepared from magnesium oxide is heavy and settles fast. Therefore,
magnesium hydroxide is prepared from both magnesium sulphate and light magnesium oxide.
The prepared magnesium hydroxide will remain in colloidal condition for a longer time, without
formation of clumps. Thus, the magnesium hydroxide preparation is neither too viscous to
obstruct pouring from the container nor too thin to allow undue settling.
After filtration, the precipitate of magnesium hydroxide is washed several times with water to
remove sulphate ions (Na2SO4 2Na+ + SO42-). Sodium sulphate is soluble in water. The
mixture must be made free from sulphate ions, otherwise purgative action of sodium sulphate
precipitates. Further it also causes constipation problem at a later period. After thorough washing
of the filter cake, the pH of the final product is nearly 10. Chloroform acts as a preservative. In
place of chloroform, 0.2% w/v methyl paraben or 0.125% w/v sodium benzoate or a similar
preservative can also be used.
If glass containers are to be used for supplying this formulation, 0.1% w/v citric acid may be
added to minimize the leaching of alkali from the glass containers into milk of magnesia. In case
of plastic containers, citric acid is not added.
Magnesium hydroxide mixture should not be stored in a cold place because freezing produces a
coarsening of the particles.
Formula:
Light magnesium oxide 52.5 g
Sodium hydroxide 15.0 g
Magnesium sulphate 47.5 g
Chloroform 2.5 ml
Purified water qs 1000 ml
Sulphate test: A few drops of washings are treated with a few drops of barium chloride solution.
If sulphate ions are present, the following reaction takes place:
Sulphate test reaction, observation, and inferences are given in the following table:
Test Observation Inference Test Observation Inference
A few drops No precipitate No Add a few Traces of Sulphate ions
of washings formed or doubt reaction drops of precipitate absent, stop
+ a few drops of forming a takes dilute dissolve or washing
of barium precipitate place hydrochloric clear solution
chloride acid to the
reagent above Sulphate ions
mixture present,
Reaction
White precipitate Precipitate
takes continue
formed insoluble
place washing
1. The washed precipitate is mixed with purified water.
2. Chloroform is dissolved in the above mixture.
3. The volume is made up to the required quantity with purified water.
4. The suspension is transferred into a tightly closed container.
5. The container is caped, polished, labelled, and submitted.
Requirements: Calamine, zinc oxide, bentonite, sodium citrate, liquefied phenol, glycerine, rose
water, etc.
Theory: Lotions are usually liquid suspensions or dispersions meant for application to the skin
without friction.
Lotions are applied to the skin using absorbent material such as cotton. Calamine lotion is used
as a topical protectant. Calamine is a zinc oxide with a small amount of ferric oxide. The powder
has pink colour. It is used as astringent and protective for obtaining relief from sunburn, insect
bite, and other similar irritations. The pink colour helps to disguise the presence of lotion on
skin. Zinc oxide is used as an astringent and produces weak antimicrobial action. The
antimicrobial and astringent actions of zinc oxide are due to the release of zinc. Zinc is released
from zinc oxide on hydrolysis in the acidic moisture of the skin.
Bentonite is a natural colloidal hydrated aluminium silicate. It is pale buff coloured powder. It is
insoluble in water, swells nearly 12 times of its bulk and forms magma with desirable rheological
characters. Hence, it is used as a suspending agent. Sodium citrate acts as a buffer and maintains
the pH within limits appropriate to skin application. It also helps in the suspending action of
bentonite and prevents frothing on shaking the preparation. Liquefied phenol acts as an
antiseptic, preservative, and local anaesthetic. Glycerine is used for its soothing action and makes
the preparation more viscous for the proper application of skin. It is also used as emollient and
humectants. Rose water gives a good odour (smell) to the preparation.
Advice for Patients: The lotion should be applied to the skin as required and allowed to dry.
Camphor Liniment IP
Experiment No. 13
Theory: Camphor liniment is used as antipruritic and counter-irritant. This solid can be supplied
in a liquid form using any one of the vehicles, namely alcohol, chloroform, volatile oils, fixed
oils etc. Liquid preparations are convenient to apply on topical areas. As liniments are applied on
the restricted topical areas with massage, their preparations must be highly viscous. To achieve
this property, it is preferred to dissolve the camphor in fixed oils. Camphor dissolved in arachis
oil produces ideal properties for a liniment. Dissolution of camphor can be further enhanced by
heating the dispersion.
Formula:
Camphor 200 g
Arachis oil 800 g
Object: To prepare and submit 20 ml of potassium chlorate and phenol gargle BPC.
Theory: Potassium chlorate and phenol gargle BPC is used as an astringent and antimicrobial.
Potassium chlorate acts as a mild astringent to tone up the relaxed throat. It also stimulates
secretion of saliva that relieves dryness. Liquefied phenol acts as an antimicrobial agent.
Liquefied phenol is very caustic and therefore care is necessary while handling (measuring) it.
Patent blue V is used as a colouring agent. As the quantity of colouring agent is less, it is
difficult to weigh required amount. Alternatively, a stock solution of patent blue V (50 mg/100
ml) in water is prepared. From this, the required volume (equivalent to its weight) is transferred
to the preparation.
Gargles are usually supplied in colourless containers. But this preparation must be protected
from light. Therefore, it is advisable to store this preparation in light-resistant container.
Since chlorate might be toxic if swallowed, an appropriate warning ‘do not swallow’ should be
written on the label of the bottle.
Potassium chlorate is soluble in water and phenol is miscible with water. Therefore, this gargle is
prepared by simple dissolution of potassium chlorate in water followed by liquefied phenol and
finally addition of patent blue V.
Formula:
Potassium chlorate 30 g
Liquefied phenol 15 ml
Patent blue V 0.01 g
Water qs 1000 ml
Theory: Phenol gargle is used as antibacterial in the treatment of pharynx and nasopharynx.
Phenol is miscible with glycerine. However, when phenol-glycerin is mixed with large volume
of water, phenol may be thrown out from the solution. To get a clear solution, the patient is
advised to shake the preparation well before use. Phenol-glycerin is prepared by mixing 5 g of
phenol with 95 g of glycerine. Phenol acts as a mild antibacterial agent to act against
microorganisms. To increase the contact of the preparation, with the membranous lining of the
throat, glycerine is added. Glycerine increases the viscosity of the preparation with an added
advantage of giving its mild sweet taste. Amaranth solution is added as a colouring agent to
improve organoleptic properties. Water is a vehicle in this preparation.
Phenol gargle is prepared by simple mixing of phenol-glycerin and amaranth solution with
purified water, as they are miscible.
Formula:
Phenol-glycerin 50 ml
Amaranth solution 10 ml
Water qs 1000 ml
Category: Antibacterial.
Theory: Fresh orange peel is the fresh outer part of the pericarp of the ripe or nearly ripe fruit of
Citrus aurantium family Rutaceae. The inner white portion of the peel is excluded because it
gives bitter taste to the preparation. Fresh orange peel is used for extraction because it contains
more volatile oil than the dry peel. Orange tincture is a permanent non-extemporaneous product
and can be made in quantity when fresh peel is available. The peel is thinly sliced to expose the
oil glands embodied therein and to expose more surface area to the action of solvent. The vessel
is closed to prevent the volatilization of volatile oils and alcohol. To affect solution of the
volatile oils, alcohol 70% or more is required. Fresh orange peel contains a large proportion of
water which dilutes alcohol 90% used to 73-78% v/v. During maceration process, occasional
stirring is necessary to displace the saturated layers of menstruum around the drug. This leads to
more effective extraction. Filtration is necessary to remove insoluble cell contents which are
introduced due to pressing of marc. Adjustment to volume is not made to keep uniformity in
strength of the finished product.
Formula:
Fresh orange peel, in thin slices 250 g
Alcohol, 90% qs 1000 ml
Dose: 2 to 4 ml.
Storage: Store in a well-closed container protected from light and in a cool place to prevent
volatilization and deterioration of active constituents.
Theory: Ginger consists of the rhizome of Zinziber officinale family Zinziberaceae. Ginger, in
moderately coarse powder, is used to expose an adequately large surface to the solvent action of
the menstruum. The oleo-resins present in the drug are not soluble in water or dilute alcohol
hence; a strong alcohol must be used to effect extraction. Before packing the drug in the
percolator, moistening is done to swell the drug otherwise is the swelling takes place in the
percolator it will lead to tight packing of the drug and percolation would not take place. After
packing the moistened drug in the percolator, sufficient menstruum is poured and allowed to set
aside for 24 hours so that during this period much of the soluble matter passes into solution. The
marc is pressed to recover as much as possible of the menstruum. This practically does not
contain any medicinally active constituents. It is done just for reasons of economy. Filtration is
done to remove the cell debris expelled by expression of the marc.
Formula:
Ginger, in moderately coarse powder 500 g
Alcohol, 90% qs 1000 ml
Category: Carminative.
Formula:
Liquid paraffin 500 g
Purified water, freshly boiled and cooled 445 g
Cetostearyl alcohol 50 g
Cetrimide 5g
Category: Bactericide.
Uses: It should be used as antiseptic cream for the treatment of wounds and burns; for the pre-
operative cleansing of the skin and for the removal of scabs and crusts in skin diseases.