Capsule

Posted: Juni 24, 2012 in Analist, General monograph

 LiteratureIndonesia Pharmacopoeia III

CAPSULAE
capsule

Capsule dosage form drug is encased in the capsule shells, hard or soft. Capsule shell is made of gelatin with or other additives.
TERMS capsules must meet the following requirements:

Uniformity of weight way to dry capsule containing drugs. Weigh 20 capsules. Weigh again capsules one by one. Remove the contents of all capsules, weigh all parts of the capsule shell. Calculate the weight of the contents of the capsule and the average weight of the contents of the capsule. Difference in the percent content of each capsule contents weight of an average weight of each capsule contents should not be determined from column A and for every 2 capsules no more than the specified column B.

The average weight of the contents of the capsule

Difference in % weight content of the capsule

A

B

120 mg or more
>120 mg

± 10 %
± 7.5%

± 20 %
± 15 %

The way to medicine capsules containing liquid or paste material. Weigh 10 capsules. Weigh again one at a time capsule. Remove the contents of all capsules. Wash the shells of capsules with a concentrated ether. Discard the liquid washing, allow it to not smell ether, weigh all parts of the capsule shell. Calculate the weight of the capsule and the average weight of the contents of the capsule. Percent difference in weight of the contents of each capsule on an average weight of the contents of each capsule is not more than 7.5%.

Time shattered. Perform the test of time were destroyed using the tool as shown in Compressi. Unless otherwise stated, the time required for capsule manghancurkan no more than 15 minutes.
Storage. In a tightly closed container, preferably contains a drying agent, in a cool.

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