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Fill Weight Variation Release and Control of Capsules, Tablets, and Sterile Solids

 

作者: Charles Roberts,  

 

期刊: Technometrics  (Taylor Available online 1969)
卷期: Volume 11, issue 1  

页码: 161-175

 

ISSN:0040-1706

 

年代: 1969

 

DOI:10.1080/00401706.1969.10490668

 

出版商: Taylor & Francis Group

 

数据来源: Taylor

 

摘要:

TheUnited States Pharmacopeiagives specifications for fill weight variation of capsules, tablets, and sterile solids to which the federal government expects the pharmaceutical industry to adhere. This paper makes probability statements about the USP weight variation test that could form the basis for a criterion for both final product release and in-process control, as far as fill weight variation is concerned. Use is made of the fact that the coefficient of variation, the standard deviation divided by the mean, efficiently describes fill weight variation. The effect of un-intentional overfill on control is considered. A certain final product weight variation specification is examined and mention is made of sampling methods.

 

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