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Update to Avantor’s response to the coronavirus (COVID-19) pandemic

Ethanol ≥96% (v/v), EMPROVE® EXPERT Ph. Eur., JP, USP suitable for use as excipient, SAFC®

Supplier: EMD MILLIPORE - PCS - GPS
Danger

1.00967.4003 1.00967.2500 1.00967.6025 1.00967.6190 1.00967.9180
EM1.00967.4003EA 408.9 USD InStock
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
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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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