Application

Intended for sensitive detection of analytes of ICH classes 1, 2 and 3 in residue and environmental analysis:Every residual solvent of class 1 acc. ICH ≤ 1 µg/gEvery residual solvent of class 2 acc. ICH ≤ 10 µg/gEvery residual solvent of class 3 acc. ICH ≤ 50 µg/g

General description

SupraSolv^® high-purity solvents are specially designed for headspace-gas chromatography (HS-GC) for the analysis of residual solvents (RS) in active pharmaceutical ingredients, excipients and drug products according to Ph. Eur and USP. The concentrations of RS for high purity solvents are specified following ICH (International Council for Harmonizaton of Technical Requirements for Registration of Pharmaceuticals for Human Use) Guideline Q3C “Impurities: Guideline for Residual Solvents”.

Legal Information

SUPRASOLV is a registered trademark of Merck KGaA, Darmstadt, Germany

Packaging

0.5, 1, 2.5 l in Glass bottle