| Function: | Hormones and Regulation of Endocrine Function of Drug |
|---|---|
| Certification: | GMP |
| Grade Standard: | Medicine Grade |
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| Item | LIMIT |
| INDENTIFICATION | AS PER USP28 |
| organic volatile impurities | AS PER USP28 |
| Chromatographic purty | AS PER USP28 |
| Specific rotation[a]D20 |
-215°~ -225° |
| Heavy metals(Pb) |
≤0.0015% |
| Loss on drying |
≤0.2% |
| Residue on ignition |
≤0.4% |
| Assay |
98.5~101.5% |
| Arsenic |
≤1.5PPM |
| Sulfate |
≤0.04% |
| Chloride |
≤0.15% |
| Iron |
≤0.003% |
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