|
S.No.
|
CHARACTERISTICS
|
SPECIFICATIONS
|
TEST METHOD NO.
|
|
1)
|
Description
|
White crystal or crystalline powder. Odourless, or has a slight odor.
|
As per USP
|
|
2)
|
Solubility
|
Sparingly soluble in water, freely soluble in boiling water, in boiling alcohol and in solutions of alkali hydroxides & carbonates. Practically insoluble in ether.
|
As per USP
|
|
3)
|
Assay %w/w (On dry basis) (By HPLC)
|
99.0-101.0%
|
As per USP
|
|
4)
|
Identification
|
A. Infrared matches that of a similar preparation of USP Niacin Reference standard.
|
As per USP
|
|
B. Ultraviolet spectrum matches that of similar preparation of USP Niacin Reference Standard.
0.35<=A237/A262 < 0.39
|
As per USP
|
|
5)
|
Loss on drying, %w/w
|
1.0 (max.)
|
As per USP
|
|
6)
|
Residue on ignition, % w/w
|
0.10 (max.)
|
As per USP
|
|
7)
|
Ordinary impurities (by TLC)
|
To comply
|
As per USP
|
|
8)
|
Organic volatile impurities
|
To comply
|
As per USP
|
|
9)
|
Heavy metals (As Pb), ppm
|
20 (max.)
|
As per USP
|
|
10)
|
Chloride ppm
|
200 (max.)
|
As per USP
|
|
11)
|
Sulfate ppm
|
200 (max.)
|
As per USP
|
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