what is the major definition and difference between
uniformity of content and content uniformity as official
test for all tablets?
Answers were Sorted based on User's Feedback
Answer / rama
both the terms are same uniformity of content or content
uniformity.
and CU/UOC is not carried out by two methods. u are
confused between uniformity of dossage units.
UOD is done via two methods CU & MV
UOC is done via individual assay
Is This Answer Correct ? | 47 Yes | 15 No |
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 |
uniformity of content(dosage unit):is by two method by
weight variation and by content uniformity.wt variation
means performing assay annd relating with indiviual unit
weight of dosage form.and content uniformity means for ten
sample (dosage unit) individually analysed
Is This Answer Correct ? | 48 Yes | 25 No |
Answer / ameer
http://www.usp.org/sites/default/files/usp_pdf/EN/USPNF/2011-02-25905UNIFORMITYOFDOSAGEUNITS.pdf
Is This Answer Correct ? | 0 Yes | 0 No |
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