European Pharmacopoeia/ICH Class 2 Mix C
Material: (6 components)
Compound List: 2-Ethoxyethanol (110-80-5), 160 µg/mL
Ethylene glycol (107-21-1), 620 µg/mL
Formamide (75-12-7), 220 µg/mL
2-Methoxyethanol (Methyl Cellosolve) (109-86-4), 50 µg/mL
N-Methylpyrrolidone (872-50-4), 4,840 µg/mL
Sulfolane (126-33-0), 160 µg/mL
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, 1 mL/ampul
Min Shelf Life on Ship Date: 6 months
Product Name: European Pharmacopoeia/ICH Class 2 Mix C
Product Type: Multi-Component Standard
Solvent Code: W
Units: ea.