Analysis Note

Purity (GC): ≥ 99.5 %Identity (IR): conformsColour: ≤ 10 HazenAcidity: ≤ 0.001 meq/gAlkalinity: ≤ 0.002 meq/gWater: ≤ 0.1 %GC/HS (Every residual solvent of class 1acc. ICH): ≤ 1 µg/gGC/HS (Every residual solvent of class 2acc. ICH): ≤ 10 µg/gGC/HS (Every residual solvent of class 3acc. 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.Each unknown measured against butyl methyl ketone up to anisole is ≤ 10 µg/g.Formic acid, acetic acid, dimethylacetamide and dimethyl sulfoxide are not detected.

Application

Solvent for HS-GC analysis of residual solvents of ICH classes 1, 2 and 3 according to Ph. Eur. And USP.

General description

SupraSolv^® high-purity solvents for headspace-gas chromatography (HS-GC) are developed specially for the analysis of residual solvents (RS) in active pharmaceutical ingredients (APIs), excipients and drug products according to 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

2.5 l in Glass bottle