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5.00299 SAFC

Nicotinamide

EMPROVE® ESSENTIAL Ph Eur,BP,USP,JP,FCC

Synonym: Nicotinamide, Niacinamide, 3-Pyridinecarboxamide, Nicotinamide

  • CAS Number 98-92-0

  • Empirical Formula (Hill Notation) C6H6N2O

  • Molecular Weight 122.12

  •  MDL number MFCD00006395

  •  EC Index Number 202-713-4

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Properties

Related Categories APIs (Active Pharmaceutical Ingredients) and Excipients, Biopharmaceutical Process Development and Manufacturing, Excipients, Ingredients for Liquid Dosage Formulation, Ingredients for Solid Dosage Formulation,
Agency/Method   BP
  JP
  Ph Eur
  USP
Quality Level   500
reg. compliance   FCC
autoignition temp.   480 °C
potency   3530-3540 mg/kg LD50, oral (Rat)
  >2000 mg/kg LD50, skin (Rabbit)
pH   6.0-7.5 (20 °C, 50 g/L in H2O)
bp   150-160 °C/0.0007 hPa
mp   128-131 °C (sublimed)
transition temp   flash point 182 °C
density   1.40 g/cm3 at 20 °C
bulk density   360 kg/m3
InChI   1S/C6H6N2O/c7-6(9)5-2-1-3-8-4-5/h1-4H,(H2,7,9)
InChI key   DFPAKSUCGFBDDF-UHFFFAOYSA-N
storage conditions   Store at +15°C to +25°C.

Description

Analysis Note

Assay (perchloric acid titration, calculated on dried substance): 99.0 - 101.0 %
Assay (HPLC, calc. on dried substance): 98.5 - 101.0 %
Identity (IR-spectrum) (Ph Eur): passes test
Identity (IR-spectrum) (USP): passes test
Identity (coloring 1): passes test
Identity (coloring 2): passes test
Identity (UV/VIS-Spectrum): passes test
Appearance: White to almost white, crystalline powder
Appearance of solution (50 g/l; water): Clear, colourless, not more intense in color than reference solution BY₇
pH (50 g/l; water): 6.0 - 7.5
Melting range (lower value): ≥ 128 °C
Melting range (upper value): ≤ 131 °C
Absorption ratio (A 245 nm/A 262 nm): 0.63 - 0.67
Chloride (Cl): ≤ 210 ppm
Sulfate (SO₄): ≤ 190 ppm
Heavy metals (as Pb) (Ph Eur): ≤ 30 ppm
Heavy metals (as Pb) (USP): ≤ 30 ppm
Heavy metals (as Pb) (JP): ≤ 30 ppm
As (Arsenic): ≤ 3 ppm
Cu (Copper): ≤ 20 ppm
Pb (Lead): ≤ 2 ppm
Zn (Zinc): ≤ 25 ppm
Residual solvents (ICH Q3C): excluded by production process
Readily carbonisable substance: passes test
Related substances (HPLC) (Major unspecified impurity): ≤ 0.10 %
Related substances (HPLC)(Sum of all impurities): ≤ 0.2 %
Sulfated ash (600 °C): ≤ 0.1 %
Loss on drying (Vacuum; 18 h): ≤ 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, USP, FCC, JP.

Safety & Documentation

Safety Information

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