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5.00005 SAFC

Nicotinic acid

extra pure Ph Eur,BP,USP

Synonym: Niacin, 3-Pyridinecarboxylic acid, Nicotinic acid

  • CAS Number 59-67-6

  • Linear Formula 3-(COOH)-C5H4N

  • Molecular Weight 123.11

  •  EC Index Number 200-441-0

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Properties

Related Categories APIs (Active Pharmaceutical Ingredients) and Excipients, Biopharmaceutical Process Development and Manufacturing, Excipients, Ingredients for Solid Dosage Formulation, Solid Dosage Forms More...
grade   BP
  Ph Eur
  USP
autoignition temp.   >365 °C (Dust)
potency   >5000 mg/kg LD50, oral (Rat)
  >2000 mg/kg LD50, skin (Rat)
pH   2.7 (20 °C, 18 g/L in H2O)
mp   236.6 °C
transition temp   flash point 193 °C
density   1.47 g/cm3 at 20 °C
bulk density   330 kg/m3
storage conditions   Store at +15°C to +25°C.

Description

Analysis Note

Assay (alkalimetric, calculated on dried substance): 99.5 - 100.5 %
Assay (HPLC, calculated on dried substance): 98.0 - 102.0 %
Identity (HPLC): passes test
Identity (IR-spectrum): passes test
Identity (Melting point): passes test
Identity (UV-absorption): passes test
Appearance: white to almost white, crystalline powder
Melting point: 234 - 240 °C
Absorption ratio (A 237 / A 262): 0.46 - 0.50
Chloride (Cl): ≤ 200 ppm
Sulfate (SO₄): ≤ 200 ppm
As (Arsenic): ≤ 3 ppm
Pb (Lead): ≤ 10 ppm
Cu (Copper)*: ≤ 25 ppm
Cu (Copper) (ICP)*: ≤ 25 ppm
Pd (Palladium)*: ≤ 1 ppm
Zn (Zinc): ≤ 25 ppm
Residual solvents (ICH Q3C): excluded by production process
Related substances (HPLC)(largest single impurity): ≤ 0.05 %
Related substances (HPLC, Ph Eur)(sum of all impurities): ≤ 0.05 %
Related substances (HPLC)(Isocinchomeronic acid): ≤ 0.05 %
Related substances (HPLC)(6-Hydroxynicotinic acid): ≤ 0.05 %
Related substances (HPLC)(Isonicotinic acid): ≤ 0.05 %
Related substances (HPLC)(6-Methylnicotinic acid): ≤ 0.05 %
Related substances (HPLC)(6,6‘-Dinicotinic acid): ≤ 0.05 %
Related substances (HPLC)(5-Nitronicotinic acid): ≤ 0.05 %
Related substances (HPLC)(Pyridine): ≤ 0.05 %
Related substances (HPLC)(3-Nitropyridine): ≤ 0.05 %
Related substances (HPLC)(3,5-Dinitropyridine): ≤ 0.05 %
Related substances (HPLC)(3-Ethylpyridine): ≤ 0.05 %
Related substances (HPLC)(5-Ethyl-2-methylpyridine): ≤ 0.05 %
Related substances (HPLC)(any unspecified impurity): ≤ 0.05 %
Related substances (HPLC, USP)(sum of all impurities): ≤ 0.20 %
Sulfated ash (600 °C): ≤ 0.1 %
Loss on drying (105 °C, 1h): ≤ 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
Protocols & Articles
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