Ethanol absolute, EMPROVE® EXPERT Ph. Eur., BP, ChP, JP, USP suitable for use as excipient, SAFC®
Supplier: EMD MILLIPORE - PCS - GPS
Ratings:
(No Reviews)
Total Ratings: 0
Avg. Ratings: 0.0 out of 5
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Danger
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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
Ethanol absolute, EMPROVE® EXPERT Ph. Eur., BP, ChP, JP, USP suitable for use as excipient, 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 (*).
Certifications: Conforms to Ph. Eur., BP, JP, USP
Formula:
C₂H₅OH Boiling Pt: 78.3 °C (1013 hPa) Melting Pt: –117 °C 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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