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1.08510 SAFC

Vanillin

EMPROVE® ESSENTIAL Ph Eur,BP,NF

Synonym: 4-Hydroxy-3-methoxybenzaldehyde, 4-Hydroxy-3-methoxybenzaldehyde

  • CAS Number 121-33-5

  • Linear Formula (CH3O)(OH)C6H3CHO

  • Molecular Weight 152.15

  •  EC Index Number 204-465-2

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Properties

Related Categories APIs (Active Pharmaceutical Ingredients) and Excipients, Biopharmaceutical Process Development and Manufacturing, Excipients, Liquid Dosage Forms, Solid Dosage Forms,
packaging   1 kg in Plastic bottle (1085101000)
  25 kg in Plastic drum (1085109025)
potency   ≥4200 mg/kg LD50, oral (Rat)
  >5010 mg/kg LD50, skin (Rabbit)
storage conditions   Store at +15°C to +25°C.
transition temp   flash point 160 °C
grade   BP
  NF
  Ph Eur
vapor pressure   0.0029 hPa ( 25 °C)
solubility   9 g/L
density   1.06 g/cm3 at 20 °C
autoignition temp.   >400 °C
mp   80-83.5 °C
pH   4.3 (20 °C, 10 g/L in H2O)
bulk density   600 kg/m3

Description

Analysis Note

Assay (acidimetric; calculated on dried substance): 99.0 - 101.0 %
Assay (UV, calculated on dried substance): 97.0 - 103.0 %
Identity: passes test
Appearance of solution (5 %; ethanol 96 %): passes test
Melting range (lower value): ≥ 81 °C
Melting range (upper value): ≤ 83 °C
As (Arsenic): ≤ 0.0003 %
Cu (Copper): ≤ 0.001 %
Pb (Lead): ≤ 0.001 %
Zn (Zinc): ≤ 0.001 %
Related substances (TLC): passes test
Methanol (HS-GC): ≤ 3000 ppm
Other residual solvents(Ph Eur/USP/ICH): excluded by the production process
Readily carbonisable substance: passes test
Sulfated ash: ≤ 0.05 %
Loss on drying: ≤ 1.0 %
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

Safety & Documentation

Safety Information

Symbol 
GHS07  GHS07
Signal word 
Warning
Hazard statements 
Precautionary statements 
Supplemental Hazard Statements 
irritant
WGK Germany 
1

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