Physicochemical Information
Boiling point	78 °C (1013 hPa)
Density	0.805 - 0.812 g/cm3 (20 °C)
Explosion limit	3.1 - 27.7 %(V)
Flash point	17 °C
Ignition temperature	425 °C
Melting Point	-117 °C
pH value	7.0 (10 g/l, H₂O, 20 °C)
Vapor pressure	59 hPa (20 °C)

Toxicological Information
LD 50 oral	LD50 Rat 6200 mg/kg

Safety Information according to GHS
Hazard Pictogram(s)
Hazard Statement(s)	H225: Highly flammable liquid and vapour. H319: Causes serious eye irritation.
Precautionary Statement(s)	P210: Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. No smoking. P240: Ground/bond container and receiving equipment. P305 + P351 + P338: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. P403 + P233: Store in a well-ventilated place. Keep container tightly closed.
RTECS	KQ6300000
Storage class	3 Flammable liquids
WGK	WGK 1 slightly water endangering
Disposal	1 Strongly contaminated halogen-free organic solvents: container A.

Safety Information
Hazard Symbols	Flammable
Categories of danger	highly flammable
R Phrase	R 11 Highly flammable.
S Phrase	S 7-16 Keep container tightly closed.Keep away from sources of ignition - No smoking.

Storage and Shipping Information
Storage	Store at +5°C to +30°C.

Transport Information
Declaration (railroad and road) ADR, RID	UN 1170 , 3, II
Declaration (transport by air) IATA-DGR	UN 1170 , 3, II
Declaration (transport by sea) IMDG-Code	UN 1170 , 3, II

Specifications
Assay (m/m)	92.6 - 95.2 %
Assay (V/V)	95.1 - 96.9 %
Identity (IR)	conforms
Appearance	conforms
Acidity or alkalinity	≤ 30 ppm
Density (d 20 °C/20 °C)	0.805 - 0.812
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 (GC) (Acetaldehyde and Acetal)	≤ 10 ppm
Volatile impurities (GC) (Benzene)	≤ 2 ppm
Volatile impurities (GC) (Methanol)	≤ 200 ppm
Volatile impurities (GC) (Total of other impurities)	≤ 300 ppm
Volatile impurities (GC) (disregard limit)	≤ 9 ppm
Other residual solvents (ICH Q3C)	excluded by production process
Evaporation residue	≤ 25 mg/l
Bacterial endotoxins	≤ 2.5
Total aerobic microbial count (TAMC)	≤ 100
Total combined yeasts/moulds count (TYMC)	≤ 10
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
Residues of metal catalysts or metal reagents acc. to EMEA/CHMP/SWP/4446/2000 are not likely to be present. Conforms to Ph Eur, BP

Etiketler :

etil akol ethanol etanol

MERCK 100971 Ethanol 96% suitable for use as excipient EMPROVE® exp Ph Eur,BP