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
Molecular Weight: 78.13. Empirical Formula: C2H6OS. linearFormula: (CH3)2SO. Agency: according to Ph. Eur., according to USP. Quality Level: 100. vapor density: 2.7 (vs air). vapor pressure: 0.42 mmHg ( 20 °C). product line: SupraSolv®. . Assay: ≥. 99.8% (GC). form: liquid. autoignition temp.: 573 . °F. potency: 28300 . mg/kg LD50, oral (Rat), 40000 . mg/kg LD50, skin (Rat). expl. lim.: 42 . %, 63 . °F. technique(s): GC-HS: suitable. impurities: ≤. 0.05% Water. evapn. residue: ≤. 3.0 . mg/L. color: APHA: ≤. 10. refractive index: n- UPC:
- 51241001
- Condition:
- New
- HazmatClass:
- Yes
- MPN:
- 1019001000
- CAS:
- 67-68-5
akash.verma@cenmed.com
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