USP RESIDUAL SOLVENTS

The USP general chapter <467> Residual Solvents is a method widely used for identifying and quantifying residual solvents when there is no information available on what solvents are likely to be present. USP <467> is divided into two separate sections based upon sample solubility: water soluble and water insoluble articles.

As required by the analytical procedure given in USP <467> for identifying and quantifying residual solvents in drug substances, drug products and excipients, SPEX CertiPrep now offers 35 analytes in Dimethyl Sulfoxide for Class 1, Class 2 and Class 3 solvents. Our products are manufactured and double checked by our QC department to validate the certificate of analysis which accompanies each product.

Residual solvents in pharmaceuticals are trace level impurities of volatile organic compounds in final products or excipients. In general, residual solvents originate from manufacturing processes related to the preparation of drug products. They can also form during product packaging and storage.

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