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

Ethanol 96% (v/v), EMPROVE® EXPERT Ph. Eur., BP, ChP, SAFC®

Supplier: EMD MILLIPORE - PCS - GPS
Danger

1.00971.1000 1.00971.2500 1.00971.6010 1.00971.6025 1.00971.6190 1.00971.9950
EM1.00971.1000EA 140.17 USD InStock
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
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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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