Ethanol 96% (v/v), EMPROVE® EXPERT Ph. Eur., BP, ChP, SAFC®
Supplier: MilliporeSigma
|
Danger
|
1.00971.1000
1.00971.2500
1.00971.6010
1.00971.6025
1.00971.6190
1.00971.9950
EM1.00971.1000EA
139.05
USD
EM1.00971.1000
EM1.00971.2500
EM1.00971.6010
EM1.00971.6025
EM1.00971.6190
EM1.00971.9950
Ethanol 96% (v/v), EMPROVE® EXPERT Ph. Eur., BP, ChP, SAFC®
Ethanol
Ethanol 96% suitable for use as excipient EMPROVE® exp.
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 (m/m) | 92.6 - 95.2 % |
Assay (V/V) | 95.1 - 96.9 % |
Identity (IR) | conforms |
Identity 1 (ChP) | conforms |
Appearance | conforms |
Clarity and color of solution (ChP) | conforms |
Acidity or alkalinity | ≤ 30 ppm |
Acidity or alkalinity (ChP) | conforms |
Density (d 20 °C/20 °C) | 0.805 - 0.812 |
Density (d 20 °C/20 °C) (ChP) | ≤ 0.8129 |
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 |
Other residual solvents (ICH Q3C) | excluded by production process |
Evaporation residue | ≤ 25 mg/l |
Non-volatile matter | ≤ 25 mg/l |
Bacterial endotoxins | ≤ 2.5 |
Parameter with periodic testing | |
Total aerobic microbial count (TAMC) | ≤ 100 CFU/ml |
Total combined yeasts/moulds count (TYMC) | ≤ 10 CFU/ml |
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 (*). | |
Conforms to Ph Eur, BP, ChP. |
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