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

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

: Ethyl alcohol

:64-17-5

:C₂H₅OH

:MFCD00003568

:78.3

:–117 °C

:0.7895 g/cm³ (20 °C)

:46.07 g/mol

:12

:Ambient

:1170

:3 II

:12,03806

:200-578-6

:01-2119457610-43

:GHS02

:GHS07

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