USP Residual Solvents
[Pages:3]USP Residual Solvents
? Identify and quantify residual solvents in drug substances, drug products and excipients ? Trace level impurities of volatile organic compounds in final products or excipients ? For Class 1, Class 2 and Class 3 solvents
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USP Residual Solvents
Analytical Standards for USP Residual Solvents
The USP General Chapter 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 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 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 Residual Solvents Standards are designed for use with: GC (FID, ECD, PID, TCD), GC/MS, LC, and LC/MS.
Accre
Organic Certified Reference Materials
Designed for use with GC (FID, ECD, PID, TCD),
GC/MS, LC, LC/MS
Supplied with a Certificate of Analysis
dited to 17025 & 1 Certi ed to 9001
ISO Accredited Standards
7034
USP Residual Solvents
Compound 5 Organic Volatile Impurities: Class 1 Solvents 15 Organic Volatile Impurities: Class 2 Solvents 8 Organic Volatile Impurities: Class 2 Solvents 8 Organic Volatile Impurities: Class 2 Solvents 24 Organic Volatile Impurities: Class 3 Solvents
Trimethylamine USP Class 3 Single 2 Organic Volatile Impurities: Class 3 Solvents
Compound Chlorobenzene
Cyclohexane 1,4-Dioxane Ethylene glycol Methanol Nitromethane Tetrahydrofuran 1,1,1-Trichloroethane Trichloroethene
CAS # 108-90-7 110-82-7 123-91-1 107-21-1 67-56-1 75-52-5 109-99-9 71-55-6 79-01-6
USP Residual Solvent Mixes
Concentration Multiple Multiple Multiple Multiple
1,000 g/mL 1,000 g/mL 1,000 g/mL
Volume 1 mL 1 mL 1 mL 1 mL 1 mL 1 mL 1 mL
USP Residual Solvent Singles
Concentration 1,800 g/mL 19,400 g/mL 1,900 g/mL 3,100 g/mL 15,000 g/mL 250 g/mL 3,600 g/mL 50,000 g/mL 400 g/mL
Volume 1 mL 1 mL 1 mL 1 mL 1 mL 1 mL 1 mL 1 mL 1 mL
Matrix Dimethyl sulfoxide Dimethyl sulfoxide Dimethyl sulfoxide Dimethyl sulfoxide Dimethyl sulfoxide Dimethyl sulfoxide Dimethyl sulfoxide
Part # USP-RS-C1 USP-RS-C2A USP-RS-C2B USP-RS-C2C USP-RS-C3A S-3702-DMSO USP-RS-C3B
Matrix Dimethyl sulfoxide Dimethyl sulfoxide Dimethyl sulfoxide Dimethyl sulfoxide Dimethyl sulfoxide Dimethyl sulfoxide Dimethyl sulfoxide Dimethyl sulfoxide Dimethyl sulfoxide
Part # USP-S810-DMSO USP-S1015-DMSO USP-S1715-DMSO USP-S1952-DMSO USP-S2380-DMSO USP-S2722-DMSO USP-S3460-DMSO USP-S3605-DMSO USP-S3615-DMSO
Phone: +1.732.549.7144 ? +1.800.LAB.SPEX Fax: +1.732.603.9647 spexsales@
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Spex CertiPrep is an Antylia Scientific company. Find out more at .
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