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Quality Control: Analytical Methods: Why Do I Need a Certificate of Analysis?
Author(s): Zolner William J
Issue: May/Jun 2012 - Volume 16, Number 3
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Abstract: One of the indispensable pieces of information a compounder needs with every pharmaceutical ingredient chemical is the Certificate of Analysis. In fact, it is needed with every different lot of the material, since variations from lot to lot in chemicals can be significant. This article briefly explains what a Certificate of Analysis contains, how to use it in compounding, and provides several examples to illustrate areas where errors in compounding could occur if it were not used.
Related Keywords: William J. Zolner, PhD, Certificate of Analysis, out of specification preparations, United States Pharmacopeia, USP, base-salt corrections, assay correction, water correction
Related Categories: SUPPORT, QUALITY CONTROL, UNITED STATES PHARMACOPEIA CONVENTIONS