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.
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), 1500 µg/mL Restek reference standards are formulated to correspond to the permissable daily exposure.
