Product Brief Introduction
Product name:Zidovudine
CAS:30516-87-1
MF:C10H13N5O4
MW:267.241
Product Specification
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Item |
Specification |
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Appearance |
White to yellowish powder |
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Identification |
a). By HPLC: The retention time of the major peak in the chromatogram of the sample preparation corresponds to that pf the standard preparation obtained as directed in assay by HPLC |
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B.) By IR: The infrared absorption spectrum of the sample should correspond with the standard spectrum |
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Specific optical rotation |
+60.5°-+63° |
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Moisture (K.F) |
≤1.0% |
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Residue on ignition |
≤0.25% |
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Limit of Triphenylmethanol and other impurities
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Acceptance criteria 1: |
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No secondary spot from the chromatogram of the sample solution is larger or more intense than the principal spot from the standard solution |
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The sum of the intensities of the secondary spots obtained from the sample solution corresponds to ≤3.0% |
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Acceptance criteria 2: |
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No spot corresponding to Triphenylmethanol is more intense than the corresponding spot from the standard solution |
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No secondary spot from the chromatogram of the sample solution is larger or more intense than the principal spot obtained from the standard solution |
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The sum of the intensities of the secondary spots from the sample solution corresponds to ≤3.0% |
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Limit of Zidovudine related compounds B and C |
Impurity B ≤1.0% |
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Thymine Impurity C ≤2.0% |
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All impurities from the tests for limit of Triphenylmethanol and other impurities and limit of Zidovudine related compounds B and C ≤3.0% |
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Residual solvents
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Methanol* ≤0.3% |
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1,4-Dioxane* ≤0.038% |
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Ethyl acetate* ≤0.5% |
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Toluene* ≤0.089% |
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Dimethyl sulfoxide* ≤0.5% |
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Assay |
97.0%-102.0% on the anhydrous basis |
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