Analysis Note

Purity (GC): ≥ 99.8 %Identity (IR): conformsEvaporation residue: ≤ 3.0 mg/lWater: ≤ 0.05 %Color: ≤ 10 HazenGC/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.Formic acid, acetic acid, dimethylacetamide and cumene are not detected.

Caution

Supercools easily and remelts slowly at room temperature. Solidified product can be re-liquified by warming to room temperature without detriment to the product.

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

0.5, 1, 2.5 l in Glass bottle

Specifications

Saturation Concentration in Air: 8.0 g/m3 (20 °C)