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Test Items
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Specifications
|
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Description
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White or light yellow powder
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Solubility
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Practically insoluble, very soluble in acetonitrile, in anhydrous ethanol and in ethyl acetate.
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Identification
|
Infrared Identification
|
Infrared absorption chromatograph obtained with the test solution should be consistent with that of the reference standard solution
|
|
HPLC Identification
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The retention time of the major peaks of the sample solution should correspond to that of the reference standard solution.
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Residue on Ignition
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≤0.2%
|
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Water content
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≤2.0%
(K.F.)
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Related Substances
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Impurity G
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≤2.0%
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Impurity E
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≤0.7%
|
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Impurity H
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≤0.5%
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Impurity I
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≤0.5%
|
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Maximum unknown individual
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≤ 0.2%
|
|
Total impurities
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≤3.5%
|
|
Assay
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A3+A4
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95.0%~102.0%
|
|
A4
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≥80.0%
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>>Alphabetical order
