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| Batch No. | 200202 | Approval Date | |
| Mfg. Date | 14/02/2020 | Exp. Date | |
| Tests | Results | Specifications | |
Character |
Complies |
The product should be yellow crystalline powder, have a bad smell. | |
| Melting point | 61ºC~62ºC | 60ºC~62ºC | |
Identification |
Complies | Chemistry reaction, should be positive reaction | |
| Complies | UV spectrophotometry, should comply | ||
| Complies | By IR absorption, to match with the working standard | ||
| Related substances | 0 |
For chromatograms of the test solution, if there are impurity peaks (excluding solvent peaks), the impurity A peak area with a relative retention time of about 2.1 multiplied by the correction factor 0.6 should not be larger than the main peak area of the control solution (0.10%) |
|
0 |
The single peak area due to impurities should not be greater than the principal peak area of the reference solution(0.10%) |
||
0 |
The sum of area of all impurity peaks in the chromatogram obtained with the test solution should not be greater than the area of the principal peak in the chromatogram obtained with the reference solution(0.30%) |
||
Clarity and colour of solution |
Complies |
In case of color development, it shall not be deeper than the yellow-green no. 5 standard color liquor. | |
| Loss on drying | 0.05% | ≤0.2% | |
| Residue on ignition | <0.1%<> | ≤0.1% | |
| Heavy metals | ≤10ppm | ≤10ppm | |
| Chloride | Complies | ≤0.04% | |
| Sulfate | Complies | ≤0.04% | |
| Residual solvent | 0.03% | ||
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