Dolutegravir sodium cas no 1051375-19-9
| Items |
Standard |
Results |
| Appearance |
White to faint yellow powder |
White powder |
| Solubility |
Slightly solube in water,very slightly solube in methanol. |
Complies |
| Identification |
The IR spectrum of test sample is concordant with that of the dolutegravir Sodium Reference Standard obtained in the similar manner. |
Complies |
| The retention time of the major peak in the chromatogram of the test solution corresponds to that in the chromatogram of the reference standard solution,as obtained in the test of assay. |
Complies |
| The water solution of this product presents identification reaction of sodium salt. |
Complies |
| Water |
Not more than 1.0% |
0.1% |
Enantiomer
|
RR enantiomer is not more than 0.15% |
0.012% |
| SR enantiomer is not more than 0.15% |
0.026% |
| RS enantiomer is not more than 0.15% |
Not detected |
Organic impurities
|
Impurity C is not more than 0.15% |
0.0042% |
| Impurity D is not more than 0.15% |
0.026% |
| Impurity E is not more than 0.15% |
0.032% |
| Impurity F is not more than 0.15% |
0.017% |
| Any individual unspecified impurity is not more than 0.10% |
0.022% |
| Total impurities is not more than 1.0% |
0.15% |
Residual Solvents
|
Tetrahydrofuran(THF)is not more than 0.072% |
Not Detected |
| Ethanol is not more than 0.5% |
Not Detected |
| Dichloromethane is not more than 0.06% |
Not Detected |
| Total residual solvents is not more than 0.5% |
Not Detected |
| Assay |
98.0%-102.0%(on anhydous basis) |
100.7% |
For customer reference only.
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