» 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 95.0 percent and not more than 110.0 percent of the labeled amount of C6H5NO2.
Packaging and storage Preserve in single-dose or in multiple-dose containers, preferably of Type I glass.
USP Reference standards 11
USP Endotoxin 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.
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:
(50 / V)(AU / AS)in which V is the volume, in mL, of Injection taken.
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USP35NF30 Page 4042