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S.No.
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CHARACTERISTICS
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SPECIFICATIONS
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TEST METHOD NO.
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|
1)
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Description
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White crystal or crystalline powder. Odourless, or has a slight odor.
|
As per USP
|
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2)
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Solubility
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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
|
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3)
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Assay %w/w (On dry basis) (By HPLC)
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99.0-101.0%
|
As per USP
|
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4)
|
Identification
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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)
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Loss on drying, %w/w
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1.0 (max.)
|
As per USP
|
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6)
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Residue on ignition, % w/w
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0.10 (max.)
|
As per USP
|
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7)
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Ordinary impurities (by TLC)
|
To comply
|
As per USP
|
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8)
|
Organic volatile impurities
|
To comply
|
As per USP
|
|
9)
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Heavy metals (As Pb), ppm
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20 (max.)
|
As per USP
|
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10)
|
Chloride ppm
|
200 (max.)
|
As per USP
|
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11)
|
Sulfate ppm
|
200 (max.)
|
As per USP
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