USP Standards
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USP  Standards - 1

Analytical Standards for USP <467> 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 checked by our QC department in order 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. SPEX CertiPrep's USP <467> Residual Solvents Standards are designed for use with: GC (FID, ECD, PID, TCD), GC/MS, LC, and LC/MS. For additional product information, please visit www.spexcertiprep.com/products/USP. CERTIFIED REFERENCE MATERIALS SPEX CertiPrep is the industry leader for over 60 years in the CRM marketplace meeting the needs of laboratories worldwide with innovation and research. Accredited by A2LA to ISO/IEC 17025:2005 & ISO Guide 34:2009. Certified by UL-DQS, ISO 9001:2015.

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USP  Standards - 2

USP <467> Residual Solvents (cont'd) USP <467> Residual Solvent Singles 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. © 2017 SPEX CertiPrep. All Rights Reserved. US ADDRESS 203 Norcross Avenue • Metuchen, NJ 08840 Tel: 1.800.LAB.SPEX • +1.732.549.7144 • Fax: 732.603.9647 CRMSales@spex.com • www.spexcertiprep.com

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