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Residual Solvents

In the pharmaceutical industry, the guidelines set by the International Conference on Harmonization (ICH), and by United States Pharmacopeia (USP) and European Pharmacopeia (EP), mandate that manufacturing solvents have to be regulated due to their toxic and/or environmentally hazardous nature.

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.

Spex’s Residual Solvents Standards are designed for use with: GC (FID, ECD, PID, TCD), GC/MS, LC, and LC/MS

USP 467 Residual Solvent Standards Brochure
Pharmaceutical Residual Solvent Standards Brochure

Concentration

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Matrix

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Volume

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