Niacin Injection

This article is compiled based on the United States Pharmacopeia (USP) – 2025 Edition

Issued and maintained by the United States Pharmacopeial Convention (USP)

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» 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.

1 USP REFERENCE STANDARDS (11)-

USP Niacin RS

1.1 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 TEST (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 and implanted Drug Products (1).

1.2 Assay-

Proceed with Injection as directed for Niacin or Niacinamide Assay (441), Chemical Method, 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)(A_U/A_S)

in which V is the volume, in mL, of Injection taken.