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Quality Control: Analytical Methods. Certificates of Analysis, Part 1

Author(s):  Allen Loyd V Jr

Issue:  Nov/Dec 2012 - Volume 16, Number 6
View All Articles in Issue

Page(s):  486-488

Quality Control: Analytical Methods. Certificates of Analysis, Part 1 Page 1
Quality Control: Analytical Methods. Certificates of Analysis, Part 1 Page 2
Quality Control: Analytical Methods. Certificates of Analysis, Part 1 Page 3

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Abstract:  The question of what tests should be evaluated for ingredient quality and what tests are most important in evaluating Certificates of Analysis (CofA) often arise among compounding pharmacists. The purpose of this article is to present the various tests that are commonly used for assessing ingredient quality and standards. These tests are based on the U.S. Pharmacopeia 35–National Formulary 30 (USP– NF). This is the first of a two-part series; Part 2 will look at specific tests and their interpretation.

Related Keywords: Loyd V. Allen, Jr., PhD, RPh, Certificate of Analysis, United States Pharmacopeia, quality assurance, monograph specifications

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

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