CAS No:30516-87-1
Shelf life:2 years
The detailed specifications are as below:
| Items | Standard |
| Description | White to yellowish powder. |
| Identification | |
| By HPLC | The retention time of the major peak in the chromatogram of the sample preparation corresponds to that of the standard preparation obtained as directed in assay by HPLC. |
| By IR | The infrared absorption spectrum of the sample should correspond with the standard spectrum. |
| Specific optical rotation | Between +60.5° and +63° |
| Water by KF | Not more than 1.0% |
| Residue on ignition | Not more than 0.25% |
| Related substance | |
| Limit of triphenylmethanol and other impurities | Acceptance criteria 1: |
| No secondary spot form the chromatogram of the sample solution is larger or more intense than the principal spot form the standard solution | |
| The sum of the intensities of the secondary spots obtained form the sample solution corresponds to not more than 3.0% | |
| Acceptance criteria 2: | |
| No spot corresponding to triphenylmethanol is more intense than the corresponding spot form the standard solution | |
| No secondary spot form the chromatogram of the sample solution is larger or more intense than the principal spot obtained form the standard solution | |
| The sum of the intensities of the secondary spots form the sample solution corresponds to not more than 3.0% | |
| Limit of Zidovudine related compounds B and C | Impurity B not more than 1.0% |
| Thymine Impurity C not more than 2.0% | |
| Not more than 3.0% for all impurities form the tests for limit of triphenylmethanol and other impurities and limit zidovudine related compounds B and C | |
| Assay | Between 97.0% and 102.0% on the anhydrous basis. |
| Residual solvents | |
| Methanol* | Not more than 0.3% |
| 1,4-Dioxane* | Not more than 0.038% |
| Ethyl acetate* | Not more than 0.5% |
| Toluene* | Not more than 0.089% |
| Dimethyl sulfoxide* | Not more than 0.5% |
*The solvents are used in the manufacturing process of zidovudine