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 95.0 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.
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.
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.
85—
It contains not more than 3.5 USP Endotoxin Units per mg of niacin.
pH 791:
between 4.0 and 6.0.
791:
between 4.0 and 6.0.
Other requirements—
It meets the requirements under Injections 1.
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:
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.
Auxiliary Information—
Please check for your question in the FAQs before contacting USP.
| Topic/Question | Contact | Expert Committee |
| Monograph | Curtis Phinney
1-301-816-8540 |
(DSN05) Dietary Supplements - Non-Botanicals |
| Reference Standards | Lili Wang, Technical Services Scientist 1-301-816-8129 RSTech@usp.org |
|
| 85 |
Radhakrishna S Tirumalai, Ph.D.
Senior Scientist 1-301-816-8339 |
(MSA05) Microbiology and Sterility Assurance |
USP32–NF27 Page 3077