Etanolo assoluto, EMPROVE® EXPERT Ph. Eur., BP, ChP, JP, USP adatto a essere utilizzato come eccipiente, SAFC®
Fornitore: MERCK PRODUCTION CHEMICALS
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Pericolo
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Synonyms:
Ethyl alcohol
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 (*).
Certificazioni: Conforms to Ph Eur, BP, JP, USP
Formula:
C₂H₅OH Peso molecolare: 46,07 g/mol Punto di ebollizione: 78,3 °C (1013 hPa) Punto di fusione: –117 °C Densità: 0,7895 g/cm³ (20 °C) Flash Pt: 12 °C Temperatura di stoccaggio: Ambiente |
MDL Number:
MFCD00003568 CAS Number: 64-17-5 EINECS: 200-578-6 UN: 1170 ADR: 3,II REACH: 01-2119457610-43 Merck Index: 12,03806 |
Risultati del test di specificazione
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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