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what is the major definition and difference between
uniformity of content and content uniformity as official
test for all tablets?
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Answer Posted / navin patel
As per USP general chapter <905>, to ensure the consistency
of dosage units uniformity of dosage unit test is
performed. The term “uniformity of dosage unit” is defined
as the degree of uniformity in the amount of the drug
substance among dosage units. It can be demonstrated by
either of two methods:
1. Weight variation: Applicable to Solutions enclosed in
unit-dose containers and into soft capsules, powders,
granules, and sterile solids that are packaged in single-
unit containers, Hard capsules, uncoated tablets, or film-
coated tablets.
2. Content Uniformity: is required for all dosage forms not
meeting the above conditions like suspensions, emulsions,
or gels in unit-dose containers. Drus substance present in
lesser proportions less tahn 25 mg.
| Is This Answer Correct ? | 35 Yes | 11 No |
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