Shimadzu Part Number:REST-36228

Residual Solvents - Pharm European Pharmocopeia ICH Class 1 Mix

European Pharmacopoeia/ICH Class 1 Mix Material: (5 components) Compound List: Benzene (71-43-2), 2 µg/mL Carbon tetrachloride (56-23-5), 4 µg/mL 1,2-Dichloroethane (107-06-2), 5 µg/mL 1,1-Dichloroethene (75-35-4), 8 µg/mL 1,1,1-Trichloroethane (71-55-6), 1,500 µg/mL Restek reference standards are formulated to correspond to the permissable daily exposure. European Pharmacopoeia Method The analysis of residual solvents in pharmaceutical products has changed, particularly for products being sold into Europe. The International Conference on Harmonization (ICH) Guidelines for Residual Solvents is becoming the international standard and is being adopted by more pharmacopoeias, including the United States Pharmacopeia, every year. The ICH method and compound list is more extensive than any method previously used and poses new challenges. Compounds in Class 1 are solvents considered to be of highest risk and to be avoided in pharmaceutical manufacturing. Use of Class 2 compounds is to be limited, as they pose a lower, but present, threat to health. Compounds in Class 3 pose the lowest toxic potential and may be used routinely in manufacturing. We prepare Rtx-1301 (cat.# 16085) and Stabilwax (cat.# 10640) capillary columns and the reference standards shown here to meet the new requirements. Certified Reference Material: Yes Solvent and Volume: Prepared in water:dimethyl sulfoxide (80:20), 1 mL/ampul Min Shelf Life on Ship Date: 6 months Product Name: European Pharmacopoeia/ICH Class 1 Mix Product Type: Multi-Component Standard Solvent Code: W:DMSO (80:20) Units: ea.
Price: $41.00
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