Hard Gelatin Capsule Shells
BRIEFING
Hard Gelatin Capsule Shells. Because there is no existing USP monograph for this product, a new monograph based on validated methods of analysis is proposed. The proposal for this product which appeared in PF 48(6) [Nov.–Dec. 2022] has been canceled and is being replaced with this new proposal. On the basis of comments received, the following sections are being revised:
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Definition
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Loss on Drying
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Disintegration
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Microbial Enumeration Tests and Tests for Specified Microorganisms
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Packaging and Storage
(GCDF: M. Marques)
Correspondence Number—C323914