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

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

Identification— To a volume of Injection, equivalent to about 100 mg of niacin, add 0.3 mL of 3 N hydrochloric acid, evaporate, if necessary, on a steam bath to about 2 mL, and allow to stand for 1 hour in a cool place. Filter by suction, wash with small volumes of ice-cold water until the last washing does not give a reaction for chloride, and dry at 105 for 1 hour: the niacin so obtained responds to Identification tests A and B under Niacin.

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

pH 791: between 4.0 and 6.0.

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 Niacin Preparation as the Standard Preparation in the Assay Procedure, and the following as the Assay Preparation. Transfer an accurately measured volume of Injection, equivalent to about 50 mg of niacin, to a 500-mL volumetric flask, dilute with water to volume, and mix. Transfer 10.0 mL of this solution to a 200-mL volumetric flask, dilute with water to volume, and mix. Calculate the quantity, in mg, of C6H5NO2 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 1520

Phone Number : 1-301-816-8389