General description
SupraSolv
solvents in drug substances, excipients and drug products according to ICH, Ph Eur and USP - SupraSolv
residual solvents defined by the ICH.
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.
Specifications
Saturation Concentration in Air: 8.0 g/m3 (20 °C)
Analysis Note
Purity (GC): ≥ 99.8 %
Identity (IR): conforms
Evaporation residue: ≤ 3.0 mg/l
Water: ≤ 0.05 %
Color: ≤ 10 Hazen
GC/HS (Every residual solvent of class 1acc. ICH): ≤ 1 µg/g
GC/HS (Every residual solvent of class 2acc. ICH): ≤ 10 µg/g
GC/HS (Every residual solvent of class 3acc. ICH): ≤ 50 µg/g
Suitable 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.
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:
- 1019002500