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TEST ITEM | SPECIFICATION | RESULTS |
Characteristic | White crystalline powder | Conform |
Odor | Characteristically mild | Conform |
Assay (%) | 98.5%-101.0% | 99. 23% |
| Identification | A.infrared spectrum is march with the spectrum of allantoin CRS | Conform |
| B.Thin-Layer Chromatographic | ||
| C.conform | ||
Acidity Or Alkalinity | Conform | Conform |
Angular Rotation | -0.10º~+0.10º | 0.03º |
Loss On Drying(%) | 0.1 max | <0.05 |
Residue On Ignition(%) | 0.1 max | <0.05 |
M.P. （℃） | 226-240 | 229 |
| Heavy Metals (pb %) | <0.001 | <0.001 |
| Ph Value | 4.5-6.5 | 5.1 |
| Related Substances(%) | 0.5max | Conform |
CONCLUSION:THE ABOVE RESULTS MEETS USP34 STANDARD
TEST ITEM | SPECIFICATION | RESULTS |
Characteristic | White crystalline powder | Conform |
Odor | Characteristically mild | Conform |
Assay (%) | 98.5%-101.0% | 99. 23% |
| Identification | A.infrared spectrum is march with the spectrum of allantoin CRS | Conform |
| B.Thin-Layer Chromatographic | ||
| C.conform | ||
Acidity Or Alkalinity | Conform | Conform |
Angular Rotation | -0.10º~+0.10º | 0.03º |
Loss On Drying(%) | 0.1 max | <0.05 |
Residue On Ignition(%) | 0.1 max | <0.05 |
M.P. （℃） | 226-240 | 229 |
| Heavy Metals (pb %) | <0.001 | <0.001 |
| Ph Value | 4.5-6.5 | 5.1 |
| Related Substances(%) | 0.5max | Conform |
CONCLUSION:THE ABOVE RESULTS MEETS USP34 STANDARD
