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1.05008 SAFC

2-Propanol

suitable for preparative chromatography EMPROVE® EXPERT Ph Eur,BP,USP

Synonym: Isopropyl alcohol, Isopropanol, iso-Propanol, IPA

  • CAS Number 67-63-0

  • Linear Formula C₃H₈O

  • Molecular Weight 60.1 g/mol

  •  EC Number 200-661-7

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Properties

Related Categories Biopharmaceutical Manufacturing, Excipients for Liquid Formulation, Process Development and Manufacturing, Small Molecule Pharmaceutical Manufacturing
grade   Ph Eur,BP,USP
packaging   1 l in Glass bottle (1050081000)
  2.5 l in Glass bottle (1050082500)
  25 l in Drum stainl. st. (1050086025)
bp   82.4 °C (1013 hPa)
expl. lim.     2 - 13.4 %(V)
vapor pressure   43 hPa (20 °C)
density   0.786 g/cm3 (20 °C)
flash point   12 °C
autoignition temp.   425 °C
mp   -89.5 °C
LD 50 oral   LD50 Rat 5045 mg/kg
LD 50 dermal   LD50 Rabbit 12800 mg/kg
shipped in   ambient
storage temp.   Store at +5°C to +30°C.
specifications   Assay (GC): ≥ 99.8 %
  Identity (IR): conforms
  Identity B (USP): conforms
  Appearance: conforms
  Acidity or alkalinity: conforms
  Acidity:
conforms
  : ≤ 0.0002 meq/g
  Alkalinity: ≤ 0.0002 meq/g
  Refractive index (n 20/D): 1.376 - 1.378
  Density (d 20 °C/20 °C): 0.785 - 0.789
  Density (d 25 °C/25 °C): 0.783 - 0.787
  Absorbance (at 230 nm): ≤ 0.300
  Absorbance (at 250 nm): ≤ 0.100
  Absorbance (at 270 nm): ≤ 0.030
  Absorbance (at 290 nm): ≤ 0.020
  Absorbance (at 310 nm): ≤ 0.010
  The spectrum shows a steadily descending curve with no observable peaks or shoulders: conforms
  Peroxides: conforms
  Volatile Impurities (GC) (individual): ≤ 0.1 % (v/v)
  Volatile Impurities (GC) (total): ≤ 1.0 % (v/v)
  Benzene and related substances (GC) (Benzene): ≤ 2 ppm
  Benzene and related substances (GC) (total of impurities apart from 2-butanol): ≤ 0.3 %
  Cyclohexane (GC): ≤ 50 ppm
  Acetone (GC): ≤ 50 ppm
  Ethanol (GC): ≤ 50 ppm
  1-Propylalcohol (GC): ≤ 50 ppm
  Isopropylether (GC): ≤ 0.01 %
  Other residual solvents (ICH Q3C): excluded bymanufacturing process
  Evaporation residue: ≤ 0.0001 %
  Water: ≤ 0.05 %
  Bacterial endotoxins: ≤ 2.5 I.U./ml
  Total aerobic microbial count (TAMC): ≤ 100 CFU/g
  Total combined yeasts/moulds count (TYMC): ≤ 10 CFU/g
  Bile-tolerant gram-negative bacteria(absent in 1 g): conforms
  Candida albicans (absent in 1 g): conforms
  Escherichia coli (absent in 1 g): conforms
  Pseudomonas aeruginosa(absent in 1 g): conforms
  Salmonella (absent in 10 g): conforms
  Staphylococcus aureus(absent in 1 g): conforms
  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, USP
Filtered by 0.2 µm filter.
Safety & Documentation

Safety Information

HS Code 
2905 12 00
Hazard Statement(s) 
H225: Highly flammable liquid and vapour.
H319: Causes serious eye irritation.
H336: May cause drowsiness or dizziness.
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.
Signal Word 
Danger
RTECS 
NT8050000
Storage class 
3 Flammable liquids
WGK 
WGK 1 slightly hazardous to water
Disposal 
1
Strongly contaminated halogen-free organic solvents: container A.
Hazard Pictogram(s) 
GHS02  GHS02
Hazard Pictogram(s) 
GHS07  GHS07
Hazard Symbols 
Flammable  Flammable
Hazard Symbols 
Irritant  Irritant
Declaration (railroad and road) ADR, RID 
UN 1219 , 3, II
Declaration (transport by air) IATA-DGR 
UN 1219 , 3, II
Declaration (transport by sea) IMDG-Code 
UN 1219 , 3, II
Categories of danger 
highly flammable, irritant
R Phrase 
R 11-36-67
Highly flammable.Irritating to eyes.Vapours may cause drowsiness and dizziness.
S Phrase 
S 7-16-24/25-26
Keep container tightly closed.Keep away from sources of ignition - No smoking.Avoid contact with skin and eyes.In case of contact with eyes, rinse immediately with plenty of water and seek medical advice.
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