Strategy for streamlined release identity testing of chromatography media
Abstract
In accordance with the US Code of Federal Regulations 21CFR 211.84 (6)(d)(1), a specific identity test must be performed for the release of
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Bioprocess & Bioanalytical Research, Merck Research Laboratories, Merck & Co. Inc., P.O. Box 4, WP17-101, West Point, PA 19486-004, USA
E-mail:
john_hennessey@merck.com
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In accordance with the US Code of Federal Regulations 21CFR 211.84 (6)(d)(1), a specific identity test must be performed for the release of
N. Afonina, L. Bhattacharyya and J. P. Hennessey, Jr., Analyst, 2004, 129, 1091 DOI: 10.1039/B404899G
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