1.

When Performing The ‘uniformity Of Weight’ Of The Dosage Unit, How Many Tablet/capsule Can Deviate The Established Limit?

Answer»

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 deviates 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%

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 deviates 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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