Clinical Trials, Drug Manufacturers, Technology, Therapy Area

Residual Solvents to USP <467> and <1467>

By Butterworth Laboratories

At Butterworth Laboratories Ltd we understand the importance of keeping up with changes in the Pharmacopoeias and ensuring their implementation. A revision of USP, Residual Solvents.

The revision clarified verification and validation requirements for use of the monograph for Class 1, 2, and 3 residual solvent determination in compendial materials. In addition, as part of the revision, USP <1467> was introduced to delineate verification and validation requirements. Both became effective from 1 March 2019.

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