According to Ph. Eur. and USP, SupraSolv® high-purity solvents are specifically made for headspace-gas chromatography (HS-GC) to analyze residual solvents (RS) in active pharmaceutical ingredients, excipients, and medicinal products. The concentrations of RS for high purity solvents are established in accordance with ICH (International Council for Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use) Guideline Q3C "Impurities: Guideline for Residual Solvents".
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/g
Every residual solvent of class 2 acc. ICH ≤ 10 μg/g
Every residual solvent of class 3 acc. ICH ≤ 50 μg/g
