I.P LIMIT
Tablet weight
is mainly affected by factors such as tooling of the compression
machine,head pressure,machine speed and flow properties of the
powder.Inconsistent powder or granulate density and particle size
distribution are common sources of weight variation during compression.
Variation between tablet with respect to dose and weight must be reduced to a minimum.Uniformity of weight is an in process test parameter which ensures consistency of dosage units during compression.
Test Procedure
Weigh individually 20 units selected at random and calculate the average weight.Not more than two of the individual weights deviates from the average weight by more than the percentage given in the pharmacopea and none deviates by more than twice that percentage.IP/BP & USP limits for tablet weight variation is given below.
Variation between tablet with respect to dose and weight must be reduced to a minimum.Uniformity of weight is an in process test parameter which ensures consistency of dosage units during compression.
Test Procedure
Weigh individually 20 units selected at random and calculate the average weight.Not more than two of the individual weights deviates from the average weight by more than the percentage given in the pharmacopea and none deviates by more than twice that percentage.IP/BP & USP limits for tablet weight variation is given below.
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
|
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