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
|
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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
|
|
30 minutes
|
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Enteric Capsules
|
0.1M hydrochloric acid
|
Should not disintegrate in 2 hours
|
mixed phosphate buffer pH 6.8
|
60 minutes
|
|
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.