Product name
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Celecoxib
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CAS NO.
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169590-42-5
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Appearance
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White or almost white,crystalline powder
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Solubility
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Practically insoluble in water, freely soluble in anhydrous ethanol, soluble in methylene chloride.
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Identification
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IR spectrum should comply with the CRS
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Related substance
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Impurity A: not more than 0.4%
|
Impurity B: not more than 0.10%
|
Impurity C: not more than 0.10%
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Impurity D: not more than 0.10%
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Impurity E: not more than 10 ppm
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Impurity F: not more than 0.10%
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Max individual unknown impurity: not more than 0.10%
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Total impurity: not more than 0.5%
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Heavy metals
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Not more than 20 ppm
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Water
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Not more than 0.5%
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Sulfated ash
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Not more than 0.2%
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Assay(anhydrous substance)
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98.0%-102.0%
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