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Contents Uniformity (Weight or Volume) of Packaged Dosage Forms - Pharmaguideline
Contents Uniformity (Weight or Volume) of Packaged Dosage Forms - Pharmaguideline
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The average net weight of the contents of the 10 containers is not less than the labeled amount and the net weight of the contents of any single
containers is not less than 91 % and not more than 109 % of the labeled amount where the labeled amount is 50 g or less, or not less than 95.5 %
and not more than 104.5 % of the labeled amount where the labeled is more than 50 g but not more than 100g.
If this requirement is not met, determine the net weight of the contents of 10 additional containers. The average net weight of the contents of the 20
containers is not less than the labeled amount, and the net weight of the contents of not more than 1 of the 20 containers is less than 91 % or more
than 109 % of the labeled amount where the labeled amount is 50 g or less than 95 % or more than 104.5 % of the labeled amount is more than 50 g
but not more than 100 g.
Related: Uniformity of Weight of Single-Dose Preparations
Non-viscous and free-flowing liquids- Pour completely the contents of each container into calibrated volume measures of the appropriate size and
determine the volume of the contents of the 10 containers.
The average net volume of the contents of the 10 containers is not less than the labeled amount, and the net volume of the contents of any single
containers is not less than 91 % and not more than 109 % of the labeled amount where the labeled amount is 50 ml or less, or not less than 95.5 %
and not more than 104.5 % of the labeled amount where the labeled amount is more than 50 ml but not more than 200 ml, or not less than 97 % but
not more than 103 % of the labeled amount where the labeled amount is more than 200 m1 but not more than 300 ml, If this requirement is not met,
determine the net volume of the contents of 10 additional containers.
The average net volume of the contents of the 20 containers is not less than the labeled amount, and the net volume of the contents of not more than
1 of the 20 containers is less than 91 % or more than 109 % of the labeled amount where the labeled amount is 50 ml or less or less than 95.5
percent or more than 104.5 % of the labeled amount where the labeled amount is more than 50 ml but not more than 200 ml or less than 97 % or
more than 103 % of the labeled amount where the labeled amount is more than 200 ml but not more than 300 ml.
Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of pharmaguideline.com, a widely-read pharmaceutical
blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips.
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