Abstract

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

Page(s): 393-397

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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

  • 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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