When performing the ‘uniformity of weight’ of the dosage unit, how many tablet/capsule can deviate the established limit ?
Not more than two of the
individual weights can deviates from the average weight by more than the
percentage given in the pharmacopeia and none can deviate more than twice
that percentage.
|
Weight Variation limits for Tablets:
IP/BP
|
Limit
|
USP
|
80 mg or less
|
10%
|
130mg or less
|
More than 80mg or Less than 250mg
|
7.5%
|
130mg to 324mg
|
250mg or more
|
5%
|
More than 324mg
|
Weight
Variation limits for Capsules:
IP
|
Limit
|
Less than 300mg
|
10%
|
300mg or More
|
7.5%
|
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