DMA HEADSPACE SUPRASOLV 1 L

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

Molecular Weight: 87.12. Empirical Formula: C₄H₉NO. linearFormula: CH₃CON(CH₃)₂. vapor pressure: 1.76 hPa ( 20 °C). Quality Level: 100. product line: SupraSolv^®. . Assay: ≥. 99.8% (GC). form: liquid. autoignition temp.: 400 . °C. potency: 5830 . mg/kg LD₅₀, oral (Rat). expl. lim.: 1.7-11.5 . % (v/v). technique(s): GC-HS: suitable. pH: 4 (20 . °C, 200 . g/L in H₂O). bp: 165-166 . °C/1013 . hPa. mp: -20 . °C. transition temp: flash point 64 . °C. solubility: soluble >. 1000 . g/L. density: 0.94 . g/cm³ . at 20 . °C. storage temp.: 2-30°C. InChI: 1S/C4H9NO/c1-4(6)5(2)3/h1-3H3. InChI key: FXHOOIRPVKKKFG-UHFFFAOYSA-N. Pictograms: GHS07,GHS08. Signal Word: Danger. Hazard Statements: H312 + H332 - H319 - H360D. Precautionary Statements: P202 - P280 - P302 + P352 + P312 - P304 + P340 + P312 - P305 + P351 + P338 - P308 + P313. Hazard Classifications: Acute Tox. 4 Dermal - Acute Tox. 4 Inhalation - Eye Irrit. 2 - Repr. 1B. Storage Class Code: 6.1C - Combustible, acute toxic Cat.3 / toxic compounds or compounds which causing chronic effects. WGK: WGK 2. Flash Point(F): 147.2 °F - closed cup. Flash Point(C): 64 °C - closed cup.