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
This product has met the following criteria: