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.
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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