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Renin Angiotensin Mechanism.

Evaluation of Capsules.

Pharmacopeial tests for Capsules.

A) Content of Active Ingredient

Weight of active ingredients in each capsule
Subtract from the lower limit for samples of
Add to the upper limit for samples of

15
10
5
15
10
5
0.12 g or less
0.2
0.7
1.5
0.3
0.8
1.8
More than 0.12g
And less than 0.3g
0.2
0.5
1.2
0.3
0.6
1.5
0.3g or more
0.1
0.2
0.8
0.2
0.4
1.0









B) Disintegration

Type of capsule

Disintegration time
Hard Capsules
30 minutes
Enteric Capsules
0.1M hydrochloric acid
Should not disintegrate in 2 hours
mixed phosphate buffer pH 6.8
60 minutes
Soft Capsules
0.1M hydrochloric acid
60 minutes


C)Uniformity of Weight
Average weight of capsule contain
Percentage deviation
Less than 300 mg
10
300mg or more
7.5

D) Uniformity of content:

  • The capsules comply with the test if not more than one of the individual values thus obtained is outside the limits 85 to 115% of the average value and none is outside the limits 75 to 125%.
  • If two or three individual values are outside the limits 85 to 115% of the average value repeat the determination using another 20 capsules.
  • The capsules comply with the test if in the total sample of 30 capsules not more than three individual values are outside the limits 85 to 115% and none is outside the limits 75 to 125% of the average value.
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