1.00989 SAFC

Cetyl alcohol


Synonym: 1-Hexadecanol, Cetyl alcohol

  • CAS Number 36653-82-4

  • Linear Formula CH3(CH2)15OH

  • Molecular Weight 242.44

  •  MDL number MFCD00004760

  •  EC Index Number 253-149-0



Related Categories APIs (Active Pharmaceutical Ingredients) and Excipients, Biopharmaceutical Process Development and Manufacturing, Coatings & Supporting Materials, Excipients, Liquid Dosage Forms,
Agency/Method   BP
  Ph. Eur.
Quality Level   500
vapor pressure   <1 hPa ( 20 °C)
product line   Emprove® Essential
assay   ≥96% (GC)
  90.0-102.0% (GC)
form   solid
autoignition temp.   235 °C (DIN 51794)
potency   >2000 mg/kg LD50, oral (Rat)
  >2000 mg/kg LD50, skin (Rabbit)
bp   305-330 °C/1013 hPa
mp   46-52 °C
transition temp   flash point 155 °C (DIN 51758)
solubility   <0.0001 g/L
density   0.82 g/cm3 at 50 °C
bulk density   410‑450 kg/m3
InChI   1S/C16H34O/c1-2-3-4-5-6-7-8-9-10-11-12-13-14-15-16-17/h17H,2-16H2,1H3
storage conditions   Store at +5°C to +30°C.


Analysis Note

Assay (GC): 90.0 - 102.0 %
Purity (GC): ≥ 96.0 % (a/a)
Identity (GC-retention time): passes test
Identity (IR-spectrum): passes test
Appearance of solution (Ph Eur): passes test
Appearance of solution (JP): passes test
Alkalinity: passes test
Melting range (lower value): ≥ 47 °C
Melting range (upper value): ≤ 52 °C
Al (Aluminium): ≤ 1 ppm
Ester value: ≤ 2.0
Hydroxyl value: 225 - 232
Iodine number: ≤ 2.0
Acid value: ≤ 1.0
Saponification value: ≤ 2.0
Hexane (HS-GC): ≤ 290 ppm
Methanol (HS-GC): ≤ 3000 ppm
1-Butanol (HS-GC): ≤ 20 ppm
Ethanol (HS-GC): ≤ 20 ppm
Heptane (HS-GC): ≤ 20 ppm
2-Propanol (HS-GC): ≤ 20 ppm
Other residual solvents (ICH Q3C): excluded by manufactoring process
Related fatty alcohols(Sum of unspecified impurities): ≤ 1 % (a/a)
Related fatty alcohols(Sum of related fatty alcohols andunspecified impurities): ≤ 10.0 % (a/a)
Sulfated ash: ≤ 0.05 %
Water (according to Karl Fischer): ≤ 0.5 %
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 (*).
Corresponds to Ph Eur, BP, NF, JP

Legal Information

Emprove is a registered trademark of Merck KGaA, Darmstadt, Germany

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Safety Information

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