1.03000 SAFC



Synonym: Triacetin

  • CAS Number 102-76-1

  • Empirical Formula (Hill Notation) C9H14O6

  • Molecular Weight 218.20

  •  MDL number MFCD00008716

  •  EC Index Number 203-051-9



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   <0.1 hPa ( 20 °C)
product line   Emprove® Essential
form   liquid
autoignition temp.   430 °C
potency   3000 mg/kg LD50, oral (Rat)
  >5000 mg/kg LD50, skin (Rabbit)
expl. lim.   1.1-7.7 % (v/v)
pH   5.0-6.0 (20 °C, 50 g/L in H2O)
bp   258 °C/1013 hPa
mp   -78 °C
transition temp   flash point 138 °C
solubility   64 g/L
density   1.16 g/cm3 at 20 °C
InChI   1S/C9H14O6/c1-6(10)13-4-9(15-8(3)12)5-14-7(2)11/h9H,4-5H2,1-3H3
storage conditions   Store at +15°C to +25°C.



The specification of the product is part of the Emprove® Material Qualification Dossier and can be found under "General Properties".

Analysis Note

Assay (alkalimetric, calculated on anhydrous substance): 98.5 - 100.5 %
Assay (GC, calc. on anhydrous substance): 97.0 - 102.0 %
Identity (IR-spectrum): passes test
Identity (GC): passes test
Appearance: clear colorless, slightly viscous liquid, not more intense in color than reference solution Y₆
Acidity (Ph Eur/ USP): passes test
Refractive index (n 20/D): 1.430 - 1.432
Density (d 20/20): 1.159 - 1.164
As (Arsenic)*: ≤ 1.5 ppm
Acetic acid (GC): ≤ 0.1 %
Glycerol (GC): ≤ 0.1 %
1-Monoacetin (GC): ≤ 0.1 %
2-Monoacetin (GC): ≤ 0.1 %
1,3-Diacetin (GC): ≤ 0.1 %
1,2-Diacetin (GC): ≤ 0.1 %
Individual, unspecified impurity (GC): ≤ 0.1 %
Sum of all impurities (GC): ≤ 0.2 %
Acetic Acid (Acidity): ≤ 5000 ppm
Butylacetate (HS-GC): ≤ 5000 ppm
Other residual solvents (ICH Q3C): excluded by manufacturing process
Water (according to Karl Fischer): ≤ 0.2 %
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, USP

Legal Information

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

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Safety Information

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