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Niacin USP/NF monograph pages 1080-1081

Niacin molecule C6H5NO2    123.11
3-Pyridinecarboxylic acid.
Nicotinic acid   [59-67-6]

>> Niacin contains not less than 99.0 percent and not more than 101.0 percent of C6H5NO2, calculated on the dried basis.

Packaging and storage -- Preserve in well-closed containers.
USP Reference standards (11) - USP Niacin RS.
Identification -
  A: Infrared Absorption (197M).
  B: Ultraviolet Absorption (197U) -
  Solution: 1 to 50,000.
  Medium: water.
  Ratio: A237/A262, between 0.35 and 0.39.

Loss on drying (731) - Dry it at 105° for 1 hour: it loses ot more than 1.0% of its weight.
Residue - on ignition (281): not more than 0.1%.
Chloride (221) - A 0.50-g portion shows no more chloride than corresponds to 0.15 mL of 0.020 N hydrochloric acid (0.02%).

Sulfate (221) - A 0.50-g portion shows no more sulfate than corresponds to 0.10mL of 0.020 N sulfuric acid (0.02%).

Heavy Metals, Method I (231) - Mix 1g with 4 mL of 1 N acetic acid, dilute with water to 25 mL, heat gently until solution is complete, and cool: the limit is 0.002%.

Ordinary impurities (466) -
  Test solution: water.
  Standard solution: water.
  Eluant: a mixture of methanol and 0.1 N hydrochloric acid (9:1).
  Visualization: 1.

Organic volatile impurities, Method IV (467): meets the requirements.
  Test preparation - Transfer 100 mg of Niacin to a vial, add 5 mL water, seal the vial, and heat to 80° for 60 minutes.
Assay - Transfer about 200 mg of Niacin, accurately weighed, to a 500 mL volumetric flask, add water to dissolve, dilute with water to volume, and mix. Concomitantly determine the absorbances of this solution and a solution of USP Niacin RS in teh same medum, at a concentration of about 20 µg per mL, in 1-cm cells at the wavelength of maximum absorbance at about 262 nm, with a suitable spectrophotometer, using water as the blank. Calculate the quantity, in mg, of C6H5NO2 in the Niacin taken by the formula:

10C(AU/As)

in which C is the concentration, in µg per mL, of USP Niacin RS in the Standard solution, and AU and AS are the absorbances of the solution of Niacin and the Standard solution, respectively.

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