E/E absolute, EMPROVE® EXPERT USP, JP, Ph. Eur., BP, ChP suitable for use as excipient, SAFC®
Supplier: MERCK PRODUCTION CHEMICALS
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Danger
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Synonyms:
Ethyl alcohol
1.00986.1000
1.00986.2500
1.00986.6025
1.00986.6010
1.00986.9180
1.00986.1000DP
1.00986.1000_T
1.00986.2500_T
1.00986.6025_T
1.00986.6010_T
1.00986.9180_T
1.00986.9950
1.00986.1000EA
209
EUR
1.00986.1000
1.00986.2500
1.00986.6025
1.00986.6010
1.00986.9180
MERP1.00986.1000DP
MERP1.00986.1000_T
MERP1.00986.2500_T
MERP1.00986.6025_T
MERP1.00986.6010_T
MERP1.00986.9180_T
1.00986.9950
E/E absolute, EMPROVE® EXPERT USP, JP, Ph. Eur., BP, ChP suitable for use as excipient, SAFC®
Ethanol
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
Formula:
C₂H₅OH MW: 46.07 g/mol Boiling Pt: 78.3 Melting Pt: –117 °C Density: 0.7895 g/cm³ (20 °C) Flash Pt: 12 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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