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

Ethanol absolute, EMPROVE® EXPERT Ph. Eur., BP, ChP, JP, USP suitable for use as excipient, SAFC®

Supplier: EMD MILLIPORE - PCS - GPS
Danger

1.00986.2500 1.00986.9950 1.00986.1000 1.00986.6010 1.00986.6025 1.00986.9180
EM1.00986.2500EA 203 USD InStock
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 (*).

Certificaciones: 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
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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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