Niacin Injection
»Niacin Injection is a sterile solution of Niacin and niacin sodium in Water for Injection,made with the aid of Sodium Carbonate or Sodium Hydroxide.It contains not less than 95.0percent and not more than 110.0percent of the labeled amount of C6H5NO2.
Packaging and storage— Preserve in single-dose or in multiple-dose containers,preferably of Type Iglass.
Identification— To a volume of Injection,equivalent to about 100mg of niacin,add 0.3mLof 3Nhydrochloric acid,evaporate,if necessary,on a steam bath to about 2mL,and allow to stand for 1hour 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 105for 1hour:the niacin so obtained responds to Identificationtests Aand Bunder Niacin.
Bacterial endotoxins á85ñ— It contains not more than 3.5USP Endotoxin Units per mg of niacin.
pHá791ñ: between 4.0and 6.0.
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 Niacin Preparationas the Standard Preparationin the Assay Procedure,and the following as the Assay Preparation.Transfer an accurately measured volume of Injection,equivalent to about 50mg of niacin,to a 500-mLvolumetric flask,dilute with water to volume,and mix.Transfer 10.0mLof this solution to a 200-mLvolumetric flask,dilute with water to volume,and mix.Calculate the quantity,in mg,of C6H5NO2in each mLof the Injection taken by the formula:
(50/V)(AU/AS),
in which Vis the volume,in mL,of Injection taken.
Auxiliary Information— Staff Liaison:Lawrence Evans,III,Ph.D.,Scientist
Expert Committee:(DSN)Dietary Supplements:Non-Botanicals
USP28–NF23Page 1369
Phone Number:1-301-816-8389