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what is the exact diff betwen the uniformity of weight &
uniformity of content?
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Answer / guest
uniformity of weight means tablet contain uniformity of weight
or not. content in uniformity means it contains stated amount
of drug or not
| Is This Answer Correct ? | 12 Yes | 2 No |
Uniformity of Weight is carried out to get information whether the weight of individual units are having uniform weight or not. It is also used to calculate content uniformity when the from the assay results only when the dosage form which are having Active Pharmaceutical Ingredient more than 25 % of the excipient used in formulation. This is carried out during chemical analysis.
Uniformity of Content is carried out to check the uniform distribution of the Active Pharmaceutical Ingredient of 10 units from the randomly selected units. This test is carried out mainly when the API content is less than 25 % of Total Formulation. This is carried out on Instrumental Analysis ( HPLC ).
| Is This Answer Correct ? | 2 Yes | 0 No |
Answer / leeladhar
Uniformity of content-applies only where the declared quantity of active ingredient in tablets, capsules, oral powders, single-dose oral suspensions or suppositories is 5 mg or less or is 5% or less of the total formulation or, in the case of sugar-coated and enteric-coated tablets.
Uniformity of mass for single-dose preparations does not apply, or for powders for injection or intravenous infusions for which the declared content of active ingredient is 40 mg or less. The test applies to all single-dose suspensions for injection
| Is This Answer Correct ? | 4 Yes | 7 No |
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