Bot Detector
IJPC Seal
Download FREE Sample Issue or Article
LEARN MORE
Subscribe Today
A subscription to IJPC includes a print copy delivered by postal mail and on-line access to electronic PDF copies of your subscribed issues.

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
View All Articles in Issue

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

Download in electronic PDF format for $65

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

Printer-Friendly Version



Related Articles from IJPC
Title/Author
(Click for Abstract / Details / Purchase)
Issue/​Page
View/Buy
Quality-Control Analytical Methods: USP Chapter <797> Compounded Sterile Preparations Sterility Requirements and Their Relationship to Beyond-Use Dating
Kastango Eric S
Sep/Oct 2004
Pg. 393-397

Wetting and/or Solubilizing Agents, Featured Excipient:
Allen Loyd V Jr
Jul/Aug 2001
Pg. 310-312

Featured Excipient: Plasticizers
Allen Loyd V Jr
Mar/Apr 2003
Pg. 145-148

Quality Control Analytical Methods: End-preparation Assessments and Tests for Compounded Sterile Preparations
McElhiney Linda F
Jul/Aug 2013
Pg. 307-311

Sterile Filtration
Akers Michael J
Sep/Oct 2015
Pg. 393-401

Quality Control: Microbial Limit Tests for Nonsterile Pharmaceuticals, Part 2
Vu Nicole
, Lou Jessica R, Kupiec Thomas C
Jul/Aug 2014
Pg. 305-310

Basics of Sterile Compounding: Intravenous Admixture Preparation, Part 12: United States Pharmacopeia Chapters Referenced in the Current United States Pharmacopeia Chapter <797> Pharmaceutical Compounding -- Sterile Preparations
Allen Loyd V Jr
Nov/Dec 2021
Pg. 491-496

Basic Compounding Documentation: The Batch Control Sheet
Tenreiro Kim
Sep/Oct 2000
Pg. 395

Application of USP-NF Standards to Pharmacy Compounding
Bormel Gail
, Valentine Joseph G, Williams Roger L
Sep/Oct 2003
Pg. 361-363

View Sample
Application of USP-NF Standards to Pharmacy Compounding
Bormel Gail
, Valentine Joseph G, Williams Roger L
Sep/Oct 2003
Pg. 361-363

View Sample
Particle Measuring Systems - USP <797> Environmental Monitoring Solutions