NIACINAMIDE I.P/B.P

NIACINAMIDE I.P/B.P

 

Medicinal

               

SPECIFICATION FOR NIACINAMIDE (NICOTINAMIDE) I.P.

Name Of Finished Product Nicotinamide
Molecular Formula C6H6N2O
Molecular Weight 122.12
Packing 20 Kgs & 25 Kgs
The Shelf-Life 5 Years
Storage Conditions And Precautions Store In A Well-Closed Containers.
NO TEST OBSERVATION
1 Description Colourless Crystals Or A White Crystalline Powder; Odourless And Bitter Taste.
2 Solubility Freely Soluble In Water, Ethanol (95%), & Slightly Soluble In Diethyl Ether.
3 Identification Test A May Be Omitted If Tests B, C &D Are Carried Out. Tests B, C And D May Be Omitted If Tests A Is Carried Out. A. Determine By Infrared Absorption Spectrophotometry. Compare The Spectrum With That Obtained With Nicotinamide RS Or With The Reference Spectrum Of Nicotinamide. B. Heat About 5 Mg In A Dry Tube; Pyridine Is Evolved. C. Boil 0.1 G With 10 Ml Of Dilute Sodium Hydroxide Solution; Ammonia Is Evolved. D. To 2 Ml Of A 0.1% W/V Solution Add 6 Ml Of Cyanogen Bromide Solution And 1 Ml Of A 2.5% W/V Solution Of Aniline; A Golden Yellow Colour Develops.
4 Appearance Of Solution A 5% W/V Solution In Carbon Dioxide-Free Water Is Clear, And Not More Intensely Coloured That Reference Solution.
5 Chloride Not More Than 250 Ppm.
6 Sulphate 1.2 G Complies With The Limit Test For Sulphates (125 Ppm).
7 Related Substances Not More Than 0.2 %.
8 Sulphated Ash Not More Than 0.1%
9 Assay, W/W 98.5 – 101.0%
10 Heavy Metals Not More Than 30 Ppm