Cleaning verification: Exploring the effect of the cleanliness of stainless steel surface on sample recovery

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• 作者：Imad A. Haidar Ahmad ; James Tam ; Xue Li ; William Duffield ; Thomas Tarara ; Andrei Blasko ; ^{andrei.blasko@novartis.com}
• 关键词：Cleaning method development ; Cleaning verification ; Coupons ; RPLC ; HPLC ; TOC
• 刊名：Journal of Pharmaceutical and Biomedical Analysis
• 出版年：2017
• 出版时间：5 February 2017
• 年：2017
• 卷：134
• 期：Complete
• 页码：108-115
• 全文大小：1520 K
• 卷排序：134

文摘

Stainless steel surface cleanliness affects API recovery. Improper cleaning is a major contributor to low and variable recoveries. With proper cleaning consistent recoveries are obtained for small molecules and proteins. This study helps minimizing the risk of false negative results and of unintentional product to product carryover that could jeopardize patient safety.