Analysis Note
residue on evaporation: ≤ 5 mg/lGC/HSEvery residual solvent of class 1 acc. to ICH: ≤ 1 µg/gEvery residual solvent of class 2 acc. to ICH: ≤ 10 µg/gEvery residual solvent of class 3 acc. to ICH: ≤ 50 µg/gSuitable as solvent for the analysis of residual solvents of ICH classes 1, 2 and 3 according to Ph Eur and USP. Formic acid, acetic acid, N,N-dimethylacetamide, N,N-dimethy lformamide and dimethyl sulfoxide are not detected.
General description
SupraSolv™ solvents for headspace gas chromatography are developed particularly for the analysis of residual solvents in drug substances, excipients and drug products according to ICH, Ph Eur and USP - SupraSolv™ headspace solvents are tested for all residual solvents defined by the ICH.
Legal Information
SUPRASOLV is a registered trademark of Merck KGaA, Darmstadt, Germany
Packaging
1, 2.5 l in Glass bottle
This product has met the following criteria: