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Quality-Control Analytical Methods: Chemical Testing Aspects of USP <797> for Compounded Sterile Preparations

Author(s):  Kupiec Thomas C

Issue:  Mar/Apr 2005 - Health and Wellness
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Abstract:  It has always been important for the pharmacist who extemporaneously compounds to ensure the strength, quality, identity, and purity of compounded preparations. With the advent of United States Pharmacopeia Chapter <797>, it has become a matter of regulatory compliance. An outside analytical laboratory can assist by analyzing potency (concentration) and sterility, thus providing quality control and quality assurance. There have been reports of tragedies resulting from a lack of quality control in the compounding pharmacy. Some of these tragedies could probably have been avoided if the pharmacy had taken a more proactive role in quality control and assurance.

Related Keywords: Thomas C. Kupiec, PhD, United States Pharmacopeia, USP Chapter <797>, potency testing, sterility testing, quality assurance, beyond-use dating, stability-indicating HPLC

Related Categories: LEGAL, SUPPORT, QUALITY CONTROL, UNITED STATES PHARMACOPEIA CONVENTIONS

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