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A propos de cet article
Quality Segment
agency
according to Ph. Eur., according to USP
vapor pressure
1.76 hPa ( 20 °C)
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
impurities
≤1 μg/g Every residual solvent of class 1 acc. to ICH, ≤10 μg/g Every residual solvent of class 2 acc. to ICH, ≤50 μg/g Every residual solvent of class 3 acc. to ICH
evapn. residue
≤3 mg/L
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
SMILES string
N(C)(C)C(=O)C
InChI
1S/C4H9NO/c1-4(6)5(2)3/h1-3H3
InChI key
FXHOOIRPVKKKFG-UHFFFAOYSA-N
General description
Application
Features and Benefits
- Regulatory compliance with ICH Q3C, Ph. Eur., and USP residual solvent guidelines, directly supporting pharmaceutical quality control workflows
- Ultra-low intrinsic volatile impurity content, eliminating solvent-derived interferences in the headspace chromatogram and ensuring an unobstructed baseline
- Batch-to-batch consistency, ensuring reproducibility across analytical campaigns
Analysis Note
- Class 1 solvents (known human carcinogens / environmental hazards): ≤ 1 µg/g
- Class 2 solvents (non-genotoxic, dose-dependent toxicants): ≤ 10 µg/g
- Class 3 solvents (low toxic potential): ≤ 50 µg/gThese specifications are verified lot-by-lot via GC/HS analysis, providing robust certification of compliance and analytical traceability.
Other Notes
Legal Information
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signalword
Danger
Hazard Classifications
Acute Tox. 4 Dermal - Acute Tox. 4 Inhalation - Eye Irrit. 2 - Repr. 1B
wgk
WGK 2
flash_point_f
147.2 °F - closed cup
flash_point_c
64 °C - closed cup
hcodes
Classe de stockage
6.1C - Combustible acute toxic Cat.3 / toxic compounds or compounds which causing chronic effects
Certificats d'analyse (COA)
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