Nicotinamide Tablets

General Notices

Action and Use

Component of vitamin B.

Definition

Nicotinamide Tablets contain Nicotinamide.

The tablets comply with the requirements stated under Tablets and with the following requirements.

Content of nicotinamide, C6H6N2O

92.5 to 107.5% of the stated amount.

Identification

A. Shake a quantity of the powdered tablets containing 0.1 g of Nicotinamide with 25 mL of absolute ethanol for 15 minutes, filter and evaporate the filtrate to dryness on a water bath. The infrared absorption spectrum of the residue, Appendix II A, is concordant with the reference spectrum of nicotinamide (RS 246).
B. The light absorption of the solution obtained in the Assay, Appendix II B, in the range 230 to 350 nm exhibits a maximum only at 262 nm and two shoulders, at 258 nm and 269 nm.
C. Shake a quantity of the powdered tablets containing 50 mg of Nicotinamide with 50 mL of water and filter. To 2 mL of the filtrate add 2 mL of cyanogen bromide solution and 3 mL of a 2.5% v/v solution of aniline and shake. A yellow colour is produced.

Tests

Related substances

Carry out the method for thin-layer chromatography, Appendix III A, using the following solutions.

(1) Shake a quantity of the powdered tablets containing 0.1 g of Nicotinamide with 15 mL of absolute ethanol, filter, evaporate to dryness on a water bath and dissolve the residue as completely as possible in 1 mL of absolute ethanol.
(2) Dilute 1 volume of solution (1) to 400 volumes with absolute ethanol.
chromatographic conditions
(a) Use a silica gel F254 precoated plate (Merck silica gel 60 F254 plates are suitable).
(b) Use the mobile phase as described below.
(c) Apply 5 µL of each solution.
(d) Develop the plate to 10 cm.
(e) After removal of the plate, dry in air and examine under ultraviolet light (254 nm).
mobile phase

10 volumes of water, 45 volumes of ethanol (96%) and 48 volumes of chloroform.

limits

Any secondary spot in the chromatogram obtained with solution (1) is not more intense than the spot in the chromatogram obtained with solution (2) (0.25%).

Assay

Weigh and powder 20 tablets. Shake a quantity of the powder containing 50 mg of Nicotinamide with 50 mL of ethanol (96%), dilute to 100 mL with ethanol (96%) and filter. Dilute 5 mL of the filtrate to 100 mL with ethanol (96%) and measure the absorbance of the resulting solution at the maximum at 262 nm, Appendix II B. Calculate the content of C6H6N2O taking 241 as the value of A(1%, 1 cm) at the maximum at 262 nm.

Storage

Nicotinamide Tablets should be protected from light.