Ethanol ≥96% (v/v), EMPROVE® EXPERT Ph. Eur., JP, USP suitable for use as excipient, SAFC®
Supplier: MilliporeSigma
|
Danger
|
1.00967.4003
1.00967.2500
1.00967.6025
1.00967.6190
1.00967.9180
EM1.00967.4003EA
386.25
USD
EM1.00967.4003
EM1.00967.2500
EM1.00967.6025
EM1.00967.6190
EM1.00967.9180
Ethanol ≥96% (v/v), EMPROVE® EXPERT Ph. Eur., JP, USP suitable for use as excipient, SAFC®
Ethanol
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., JP, USP.
Formula:
C₂H₅OH Boiling Pt: 78 °C (1013 hPa) Melting Pt: –114 °C Density: 0.805…0.812 g/cm3 (20 °C) Flash Pt: 17 °C Storage Temperature: Ambient |
MDL Number:
MFCD00003568 CAS Number: 64-17-5 EINECS: 200-578-6 UN: 1170 ADR: 3,II |
Specification Test Results
Assay (d20°C/4°C) (m/m) | 92.6 - 95.2 % |
Assay (d20°C/4°C) (V/V) | 95.1 - 96.9 % |
Assay (d 15°C/15°C) (V/V) | 95.1 - 96.9 % |
Assay (d15.56°C/15.56°C) (m/m) | 92.3 - 93.8 % |
Assay (d15.56°C/15.56°C) (V/V) | 94.9 - 96.0 % |
Identity (IR) | conforms |
Appearance | conforms |
Clarity of solution | conforms |
Color of solution | conforms |
Acidity or alkalinity | ≤ 30 ppm |
Density (d 20 °C/20 °C) | 0.805 - 0.812 |
Density (d 15 °C/15 °C) | 0.809 - 0.816 |
Density (d 15,56 °C/15,56 °C) | 0.812 - 0.816 |
Specific gravity (d 15 °C/15 °C) | 0.80872 - 0.81601 |
Absorbance (at 240 nm) | ≤ 0.40 |
Absorbance (between 250nm and 260nm) | ≤ 0.30 |
Absorbance (between 270nm and 340nm) | ≤ 0.10 |
The spectrum shows a steadily descending curve with no observable peaks or shoulders | conforms |
Volatile impurities (Acetaldehyde and Acetal) | ≤ 10 ppm |
Volatile impurities (Benzene) | ≤ 2 ppm |
Volatile impurities (Methanol) | ≤ 200 ppm |
Volatile impurities (Total of other impurities) | ≤ 300 ppm |
Volatile impurities (disregard limit) | ≤ 9 ppm |
Residual solvents (ICH Q3C) | excluded by the manufacturing process |
Evaporation residue | ≤ 25 mg/l |
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