Irbesartan Irbesartan 99% purity High quality Irbesartan
Irbesartan 99%
Appearance
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White to Off-white, crystalline powder
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Identification
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Infrared absorption: The IR spectrum
Is consistent with that obtained with
The reference
|
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The retention time of the major peak
In the chromatogram of the Assay
Preparation corresponds to that in the chromatogram of
the Standard preparation, as obtained in the Assay
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Water
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NMT 0.5%
|
Limit of azide
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NMT 10ppm
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Heavy metals
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NMT 0.002%
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Related compounds
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Compound A NMT 0.2%
|
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Any other impurity NMT 0.1%
|
|
Total impurities NMT 0.5%
|
Residual solvents(GC)
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Ethanol NMT 5000ppm
|
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Toluene NMT 890ppm
|
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t-Butyl methyl ether NMT 5000ppm
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Assay(on the anhydrous basis)
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98.0~102.0%
|
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