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.
Chlorobenzene (108-90-7), 360 µg/mL
Cyclohexane (110-82-7), 3880 µg/mL
cis-1,2-Dichloroethene (156-59-2), 1870 µg/mL
N,N-Dimethylformamide (68-12-2), 880 µg/mL
Ethylbenzene (100-41-4), 369 µg/mL
(C6)
n-Hexane (110-54-3), 290 µg/mL
Methylcyclohexane (108-87-2), 1180 µg/mL
Methylene chloride (dichloromethane) (75-09-2), 600 µg/mL
Toluene (108-88-3), 890 µg/mL
1,1,2-Trichloroethene (79-01-6), 80 µg/mL
m-Xylene (108-38-3), 1302 µg/mL
o-Xylene (95-47-6), 195 µg/mL
p-Xylene (106-42-3), 304 µg/mL
