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Enhanced Residual Solvents Analysis: A Practical Approach to Sampling, Transport, Storage and Analysis.

Published 19 May 2015 | By Butterworth Laboratories Ltd

Residual solvents are organic volatile chemicals used or produced in the manufacture of active pharmaceutical ingredients (API), excipients or drug products, which remain in the material at the end of the manufacturing process. Their control is important in limiting exposure and guidelines exist to maintain patient safety, not just to satisfy competent authorities. It is a requirement that all pharmaceutical substances comply with ICH limits even if not required by individual monographs or if no compendial monograph exists.

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Enhanced Residual Solvents Analysis: A Practical Approach to Sampling, Transport, Storage and Analysis.