| ≥1 piece |
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ANALYSIS ITEM
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SPECIFICATION
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RESULT
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Appearance
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White Crystalline powder
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White Crystalline powder
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Identification (IR)
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According to the standard IR spectrum
|
Complies
|
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Solubility
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soluble inDMSO AND ethanol,insoluble in water or 2-hydroxy propyl CB-cyclodextrin,
Solubilized by chloroform and Complies carbinol appreciably,hardly ??by water
|
complies
|
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Clarity and color
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Clarification,not more intensely coloured than yellow reference No.1
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Complies
|
|
Assay
|
98.0%-100.5%
|
98.32%
|
|
Melting point
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203-205/DIV>
|
203.5/DIV>
|
|
Heavy metals(pb)
|
10ppm Max.
|
3ppm
|
|
Arsenic
|
1ppm
|
0.30ppm
|
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Loss on Drying
|
0.10% max
|
0.06%
|
|
Water (K.F)
|
0.50% max
|
0.21%
|
|
Residue on Ignition
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0.10% max
|
0.05%
|
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Related Substance
(total impurities)
|
1.00% max
|
0.45%
|
|
Single impurity
|
0.50% max
|
0.25%
|
|
Residue on SOLVENT
|
10ppm
|
6ppm
|