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Environmental Reference Standards
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Method 521 (Nitrosamines)
European Pharmocopoeia/ICH Class 2 Mix A
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 analytical reference materials to meet the new requirements. Please request lit. cat.# 59107, European Pharmacopoeia Analysis of Residual Solvents for more information.
chlorobenzene 360 µg/mL
cyclohexane 3,880
cis-1,2-dichloroethene 1,870
dichloromethane 600
N,N-dimethylformamide 880
ethylbenzene 369
hexane 290
methylcyclohexane 1,180
toluene 890
1,1,2-trichloroethene 80
m-xylene 1,302
o-xylene 195
p-xylene 304
Quantity Discounts
Order 3 or 4 of any one analytical reference material
product and receive a
10% discount! Order 5 or more
of any one analytical reference material product and
receive a
20% discount!
