E/E absolute, EMPROVE® EXPERT USP, JP, Ph. Eur., BP, ChP excipient_suitable, SAFC®
Supplier: MilliporeSigma
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Danger
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Synonyms:
Ethyl alcohol
1.00986.2500
1.00986.9950
1.00986.1000
1.00986.6010
1.00986.6025
1.00986.9180
EM1.00986.2500EA
203
USD
EM1.00986.2500
EM1.00986.9950
EM1.00986.1000
EM1.00986.6010
EM1.00986.6025
EM1.00986.9180
E/E absolute, EMPROVE® EXPERT USP, JP, Ph. Eur., BP, ChP excipient_suitable, SAFC®
Ethanol
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 (*).
Certificaciones: Conforms to Ph. Eur., BP, JP, USP
Formula:
C₂H₅OH MW: 46.07 g/mol Boiling Pt: 78.3 Melting Pt: -117 Density: 0.7895 g/cm³ (20 °C) Flash Pt: 12 °C Storage Temperature: Ambient |
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 |
Specification Test Results
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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