General description
SupraSolv® high-purity solvents for headspace gas chromatography (HS-GC) are developed particularly for the analysis of residual solvents (RS) in drug substances, 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«, European Pharmacopeia (Ph. Eur. Chapter 2.4.24) and United States Pharmacopeia (USP Chapter 467).
Application
Suitable as a solvent for analysis of residual solvents of ICH classes 1, 2 and 3 according to Ph. Eur. and USP:
- 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
Features and Benefits
- high application reliability due to the application test performed on every batch produced
- application-oriented quality due to specified concentrations of residual solvents as defined by ICH
Legal Information
SUPRASOLV is a registered trademark of Merck KGaA, Darmstadt, Germany
- UPC:
- 51112515
- Condition:
- New
- Weight:
- 1.00 Ounces
- HazmatClass:
- No
- WeightUOM:
- LB
- MPN:
- 1003991000