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.

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. Our products are manufactured and verified by our QC department to validate the Certificate of Analysis which accompanies each product. Spex CertiPrep® offers analytes in dimethyl sulfoxide for Class 1, Class 2 and Class 3 solvents.

Can’t find the standards you are looking for? Spex CertiPrep® can make custom standards to meet your exact needs. Contact us for more information at [email protected] or call us at 732-549-7144.

Chemicals sold by Cole-Parmer are not intended for and should not be (i) used for medical, surgical or other patient oriented applications, or (ii) combined with any food product or ingested in any form.

This multi-component standard contains 8 components.

• 8 Organic Volatile Impurities USP <467> Pharmaceutical Residual Solvent is a 1 mL ampule which contains 250 µg/mL (250 ppm) of 2-Methoxyethanol; 800 µg/mL (800 ppm) of 2-Ethoxyethanol, Tetramethylene sulfone; 1,100 µg/mL (1,100 ppm) of Formamide; 2,650 µg/mL (2,650 ppm) of 1-Methyl-2-pyrrolidinone; 3,100 µg/mL (3,100 ppm) of Ethylene glycol; 4,400 µg/mL (4,400 ppm) of N,N-Dimethylformamide; and 5,450 µg/mL (5,450 ppm) of N,N-Dimethylacetamide.

Hazardous material shipping fees may apply.