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Quality-Control Analytical Methods: USP Chapter <797> Compounded Sterile Preparations Sterility Requirements and Their Relationship to Beyond-Use Dating

Author(s):  Kastango Eric S

Issue:  Sep/Oct 2004 - Topical Treatments in Wound Healing
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Page(s):  393-397

Quality-Control Analytical Methods:  USP Chapter <797> Compounded Sterile Preparations Sterility Requirements and Their Relationship to Beyond-Use Dating Page 1
Quality-Control Analytical Methods:  USP Chapter <797> Compounded Sterile Preparations Sterility Requirements and Their Relationship to Beyond-Use Dating Page 2
Quality-Control Analytical Methods:  USP Chapter <797> Compounded Sterile Preparations Sterility Requirements and Their Relationship to Beyond-Use Dating Page 3
Quality-Control Analytical Methods:  USP Chapter <797> Compounded Sterile Preparations Sterility Requirements and Their Relationship to Beyond-Use Dating Page 4
Quality-Control Analytical Methods:  USP Chapter <797> Compounded Sterile Preparations Sterility Requirements and Their Relationship to Beyond-Use Dating Page 5

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Abstract:  One aspect of the new United States Pharmacopeia Chapter <797> is causing confusion and concern in determining beyond-use dating and in meeting the sterility requirement: the creation of a three-risk-level classification system and strict assignment of be

Related Keywords: Eric S. Kastango, MBA, RPh, FASHP, USP-NF, BUD, contamination, validation, filtration, inoculation, TPN, media, assay, batches, batch testing, ophthalmic

Related Categories: STERILE PREPARATIONS, SUPPORT, QUALITY CONTROL, UNITED STATES PHARMACOPEIA CONVENTIONS

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