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.
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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%
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As per USP
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4)
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Identification
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A. Infrared matches that of a similar preparation of USP Niacin Reference standard.
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As per USP
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B. Ultraviolet spectrum matches that of similar preparation of USP Niacin Reference Standard.
0.35<=A237/A262 < 0.39
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As per USP
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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)
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To comply
|
As per USP
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8)
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Organic volatile impurities
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To comply
|
As per USP
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9)
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Heavy metals (As Pb), ppm
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20 (max.)
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As per USP
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10)
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Chloride ppm
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200 (max.)
|
As per USP
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11)
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Sulfate ppm
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200 (max.)
|
As per USP
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