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

USP Reference standards á11ñ— USP Niacinamide RS.USP Endotoxin RS.

Identification— Dilute a quantity of the Injection,equivalent to about 200mg of niacinamide,with water to about 10mL.Add 1mLof 2.5Nsodium hydroxide,evaporate on a steam bath to dryness,add 5mLof water,and similarly evaporate to about 1mL:during the initial evaporation,the odor of ammonia is perceptible.Neutralize to litmus paper with 3Nhydrochloric acid,add 1mLof the acid in excess,and place the solution in a refrigerator for 2hours.Then filter,wash the precipitated niacin with small portions of ice-cold water until free from chloride,and dry at 105for 1hour:the IRabsorption 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 á85ñ— It contains not more than 3.5USP Endotoxin Units per mg of niacinamide.

pHá791ñ: between 5.0and 7.0.

Other requirements— It meets the requirements under Injections á1ñ.

Assay— Proceed with Injection as directed for Chemical Methodunder Niacin or Niacinamide Assay á441ñ,using Standard Niacinamide Preparationas the Standard Preparationin the Assay Procedure,and the following as the Assay Preparation.Dilute an accurately measured volume of Injection,equivalent to about 50mg of niacinamide,with water to 500mLin a volumetric flask,and mix.Pipet 10mLof the solution into a 100-mLvolumetric flask,dilute with water to volume,and mix.Calculate the quantity,in mg,of C6H6N2Oin each mLof the Injection taken by the formula: in which Vis the volume,in mL,of Injection taken.

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

USP28–NF23Page 1370

Phone Number:1-301-816-8389