USP <467>

Residual Solvents

Solvents are very useful for the synthesis of organic compounds and are removed during the purification process.  Verification of the removal of residual solvents is evaluated utilizing gas chromatography.

General chapter <467> in the USP outlines several options for monitoring residual solvents from an additive approach from each material added or a check of the finished product. 

Each approach has pros and cons.  The advantage of evaluating each raw material is that if there is one material with a high level of residual solvents present, discarding that material before being used is more cost effective.  The disadvantage is that it takes more costly from a laboratory perspective as well as more effort is needed to keep track of the amounts observed.

The USP also includes a flow chart leading the user through a series of decisions.  A general screen may be in order or perhaps only a single solvent needs to be monitored as other solvents have been ruled out as likely to be present.

Microbac is ready to assist you with navigating this process and provide the data needed to ensure product quality.