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1.01806 SAFC

Benzyl benzoate

EMPROVE® ESSENTIAL Ph Eur,BP,USP

Synonym: Benzoic acid benzyl ester, Benzyl benzoate

  • CAS Number 120-51-4

  • Empirical Formula (Hill Notation) C14H12O2

  • Molecular Weight 212.24

  •  MDL number MFCD00003075

  •  EC Index Number 204-402-9

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Properties

Related Categories APIs (Active Pharmaceutical Ingredients) and Excipients, Biopharmaceutical Process Development and Manufacturing, Excipients, Liquid Dosage Forms, Preservatives,
Agency/Method   BP
  Ph. Eur.
  USP
Quality Level   500
vapor pressure   <0.1 hPa ( 25 °C)
autoignition temp.   480 °C
potency   1904 mg/kg LD50, oral (Rat)
  4000 mg/kg LD50, skin (Rabbit)
bp   324 °C/1013 hPa
mp   21 °C
transition temp   flash point 158 °C
density   1.12 g/cm3 at 20 °C
InChI   1S/C14H12O2/c15-14(13-9-5-2-6-10-13)16-11-12-7-3-1-4-8-12/h1-10H,11H2
InChI key   SESFRYSPDFLNCH-UHFFFAOYSA-N
storage conditions   Store at +15°C to +25°C.

Description

Application

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

Analysis Note

Assay (by alcalimetric following saponification): 99.0 - 100.5 %
Identity (IR-spectrum): passes test
Acidity: passes test
Refractive index (n 20/D): 1.568 - 1.570
Density (Ph Eur, d 20/20): 1.118 - 1.122
Density (USP, d 25/25): 1.116 - 1.120
Solidification point: ≥ 18 °C
Al (Aluminium): ≤ 1 ppm
Benzaldehyde: ≤ 0.05 %
Benzene (HS-GC): ≤ 2 ppm
Methanol (HS-GC): ≤ 3000 ppm
Toluene (HS-GC): ≤ 890 ppm
Other residual solvents (ICH Q3C): excluded by production process
Sulfated ash: ≤ 0.05 %
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

Safety & Documentation

Safety Information

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