Éthanol absolu, EMPROVE® EXPERT Ph. Eur., BP, ChP, JP, USP pouvant être utilisé comme excipient, SAFC®
Fournisseur: MERCK PRODUCTION CHEMICALS
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Danger
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For full details of specification and hazards please see www.vwr.com
Other residual solvents (ICH Q3C) excluded by production process.
Elemental impurity specifications have been set considering ICH Q3D (Guideline for Elemental Impurities).
Class 1-3 elements are not likely to be present above the ICH Q3D option 1 limit, unless specified and indicated (*).
Certifications: Conforms to Ph Eur, BP, JP, USP
Formule:
C₂H₅OH Point d'ébullition: 78.3 °C (1013 hPa) Point de fusion: –117 °C Densité: 0.7895 g/cm³ (20 °C) Point d'éclair: 12 °C Température de stockage: Température ambiante |
Numéro MDL:
MFCD00003568 Numéro CAS: 64-17-5 EINECS: 200-578-6 ONU: 1170 ADR: 3,II ATTEINDRE: 01-2119457610-43 Merck Index: 12,03806 |
Résultats des tests de spécification
Assay (m/m) | ≥ 99.2 % |
Assay (V/V) | ≥ 99.5 % |
Identity (IR) | conforms |
Identity 1 (ChP) | conforms |
Appearance | conforms |
Clarity of solution | conforms |
Color of solution | conforms |
Clarity and color of solution (ChP) | conforms |
Acidity or alkalinity | ≤ 30 ppm |
Acidity or alkalinity (ChP) | conforms |
Density (d 20 °C/20 °C) | 0.790 - 0.793 |
Density (d 15,56 °C/15,56 °C) | ≤ 0.7962 |
Density (d 15 °C/15 °C) | 0.794 - 0.797 |
Specific gravity (d 15 °C/15 °C) | 0.79422 - 0.79679 |
Absorbance (at 240 nm) | ≤ 0.40 |
Absorbance (between 250 nm and 260 nm) | ≤ 0.30 |
Absorbance (between 270 nm and 340 nm) | ≤ 0.10 |
The spectrum shows a steadily descending curve with no observable peaks or shoulders | conforms |
Absorbance (ChP) (at 240 nm) | ≤ 0.08 |
Absorbance (ChP) (between 250 nm and 260 nm) | ≤ 0.06 |
Absorbance (ChP) (between 270 nm and 340 nm) | ≤ 0.02 |
Volatile impurities (GC) (Acetaldehyde and Acetal) | ≤ 10 ppm |
Volatile impurities (GC) (Benzene) | ≤ 2 ppm |
Volatile impurities (GC) (Methanol) | ≤ 100 ppm |
Volatile impurities (GC) (Total of other impurities) | ≤ 300 ppm |
Cyclohexane (GC) | ≤ 50 ppm |
Evaporation residue | ≤ 25 mg/l |
Non-volatile matter | ≤ 25 mg/l |
Bacterial endotoxins | ≤ 2.5 I.U./ml |
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