Ethanol absolute, EMPROVE® EXPERT USP, Ph. Eur., BP suitable for use as excipient
: Ethyl alcohol
:64-17-5
:
:C₂H₅OH
:MFCD00003568
:78.3
:46.07 g/mol
:-117
:12
:3 II
:12,03806
:1170
:GHS02
:GHS07
:Freezer
- Environmentally Preferable:
- Purity (GC):99,8%
- Assay (m/m):99,2%
- Assay (V/V):99,5%
- Indentity (IR):Conforms
- Appearance:Conforms
- Colour:≤10 Hazan
- Clarity of solution:Conforms
- Colour of solution:Conforms
- Acidity or alkalinity:≤30 ppm
- Acidity (as CH₃COOH):≤30 ppm
- Refractive Index (n 25/D):1,3589 - 1,3599
- Density (d 20 °C/20 °C):0,790 - 0,793
- Density (d 15,56 °C/15,56 °C):≤0,7962
- Absorbance (at 240 nm):≤0,40
- Absorbance (between 250 and 260 nm):≤0,30
- Absorbance (between 270 and 340 nm):≤0,10
- Volatile impurities (GC; acetal and acetaldehyde):≤10 ppm
- Volatile impurities (GC; benzene):≤2 ppm
- Volatile impurities (GC; methanol):≤100 ppm
- Volatile impurities (GC; total-other impurities):≤300 ppm
- Volatile impurities (GC; disregard limit):≤9 ppm
- Cyclohexane (GC):≤50 ppm
- 2-Propanol (GC):≤30 ppm
- Evaporation residue:≤0,0001%
- Water:≤0,500%
- Bacterial endotoxins:≤2,5 IU/ml
- Total areobic microbial unit (TAMC):≤100 CFU/g
- Total combained yeasts/moulds count (TYMC):≤10 CFU/g
- Bile-tolerant gram negative bacteria (absent in 1 g):Passes Test
- Candida albicans (absent in 1 g):Passes Test
- Escherichia coli (absent in 1 g):Passes Test
- Pseudomonas aeruginosa (absent in 1 g):Passes Test
- Salmonella (absent in 10 g):Passes Test
- Staphylococcus aureus (absent in 1 g):Passes Test
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