25507-04-4
GMP certificate
Analysis Test |
Specification |
Result |
Description |
crystalline powder |
Conforms |
Solubility |
soluble in water |
Conforms |
PH |
6.0~7.5 |
6.9 |
Solution clarity and color |
solution should be clear and colorless |
Conforms |
Related substances |
5’CMP 0.3% Simple impurity Total other impurity |
0.01% 0.03% 0.10% |
Chloride |
0.05% |
Conforms |
Ammonium |
0.05% |
Conforms |
Fe |
0.01% |
Conforms |
Phosphate |
0.1% |
Conforms |
Loss on drying |
≤6.0% |
1.3% |
Heavy metals |
0.002% |
Conforms |
Arsenide |
0.0001% |
Conforms |
Bacterial Endotoxins |
0.3EU/mg |
Conforms |
Microbial Limit |
Conforms |
Conforms |
Assay(on dried basis) |
≥98.0% |
98.8% |
Conclusion: The results conform with CP2010 |
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