| Customization: | Available |
|---|---|
| CAS No.: | 204255-11-8 |
| Formula: | C16h28n2o4h3po4 |
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| item | limit |
| appearance | this product is white or almost white powder. |
| solubility | this product is soluble in water or methyl alcohol, slightly soluble in N,N-dimethylformamide |
| optical rotation | -30.7° to -32.6° |
| identification | A. test solution: meets the requirements. B. In the chromatogram of the content determination item, the retention time of the main peak of the test solution should be consistent with the retention time of the main peak of the reference solution C. The infrared absorption spectrum of this product should be consistent with the absorption spectrum of the reference substance |
| related substance | If there are impurity peaks in the chromatogram of the test solution, the peak area of impurity HAS-IM-C multiplied by a relative correction factor of 0.3 shall not exceed 1 time (0.1%) of the main peak area of the control solution, the peak area of impurity HAS-IM-B multiplied by a relative correction factor of 0.8 shall not exceed 2 times (0.2%) of the main peak area of the control solution, the peak area of impurity HAS-IM-F shall not exceed 1.5 times (0.15%) of the main peak area of the control solution, and the peak areas of impurities HAS-IM-A, HAS-IM-U, HAS-IM-P, and HAS-IM-Q multiplied by relative correction factors of 0.8, 1.1, 0.2, and 0.6 respectively shall not exceed 1.5 times (0.15%) of the main peak area of the control solution. The peak area of other individual impurities shall not exceed The main peak area of the reference solution (0.10%) and the total amount of impurities shall not exceed 0.5%. |
| enantiomer | If there are chromatographic peaks in the chromatogram of the test solution that are consistent with the retention time of the enantiomer, the peak area should not exceed 0.3 times (0.15%) of the main peak area of the control solution. |
| Acetone, chloroethane, ethanol, ethyl acetate, n-heptane, toluene | Chloroethane should not exceed 0.1%, ethanol should not exceed 0.5%, acetone should not exceed 0.5%, ethyl acetate should not exceed 0.5%, n-heptane should not exceed 0.5%, and toluene should not exceed 0.089%. |
| palladium | not more than 10ppm |
| moisture | not more than 0.5% |
| heavy metals | not more than 10ppm |
| phosphoric acid | 22.7%~25.1% |
| microbial limit | The total number of aerobic bacteria in 1g of the test sample shall not exceed 1000cfu; The total number of mold and yeast in 1g of the test sample shall not exceed 100cfu; Escherichia coli should not be detected. |
| assay | 98.5%~102.0% |
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