Packaging and storage— Preserve in single-dose or in multiple-dose containers, preferably of Type I glass.

USP Reference standards 11— USP Niacinamide RS. USP Endotoxin RS.

Identification— Dilute a quantity of the Injection, equivalent to about 200 mg of niacinamide, with water to about 10 mL. Add 1 mL of 2.5 N sodium hydroxide, evaporate on a steam bath to dryness, add 5 mL of water, and similarly evaporate to about 1 mL: during the initial evaporation, the odor of ammonia is perceptible. Neutralize to litmus paper with 3 N hydrochloric acid, add 1 mL of the acid in excess, and place the solution in a refrigerator for 2 hours. Then filter, wash the precipitated niacin with small portions of ice-cold water until free from chloride, and dry at 105 for 1 hour: the IR absorption spectrum of a potassium bromide dispersion of the residue so obtained exhibits maxima only at the same wavelengths as that of a similar preparation of USP Niacinamide RS.

Bacterial endotoxins 85— It contains not more than 3.5 USP Endotoxin Units per mg of niacinamide.

pH 791: between 5.0 and 7.0.

Residual solvents 467: meets the requirements.

Other requirements— It meets the requirements under Injections 1.

Assay— Proceed with Injection as directed for Chemical Method under Niacin or Niacinamide Assay 441, using Standard Niacinamide Preparation as the Standard Preparation in the Assay Procedure, and the following as the Assay Preparation. Dilute an accurately measured volume of Injection, equivalent to about 50 mg of niacinamide, with water to 500 mL in a volumetric flask, and mix. Pipet 10 mL of the solution into a 100-mL volumetric flask, dilute with water to volume, and mix. Calculate the quantity, in mg, of C6H6N2O in each mL of the Injection taken by the formula: in which V is the volume, in mL, of Injection taken.

Expert Committee : (DSN05) Dietary Supplements - Non-Botanicals

USP29–NF24 Page 1522

Phone Number : 1-301-816-8389