|
Item |
Standard |
Results |
Remark |
|
|
Appearance |
White powder |
Conforms |
|
|
|
Identification A, Infrared Absorption |
Match up with the spectrum |
Conforms |
|
|
|
Identification B, identification of calcium |
Normal reaction |
Conforms |
|
|
|
Identification C, Specific rotation(Dried Basis) |
+25.0---+27.5 |
+26.9 |
|
|
|
Alkalinity |
No Pink reaction within 5 seconds |
Conforms |
|
|
|
Loss on drying |
≤5.0% |
2.8% |
|
|
|
Residual Solvent(Methanol) |
≤0.3% |
0.07% |
|
|
|
Calcium Content |
8.2-8.6% |
8.4% |
|
|
|
Assay(on Dry Basis) |
98-102.0% |
100.1% |
|
|
|
Lead |
≤0.50 mg/kg |
Conforms |
|
|
|
Cadmium |
≤0.50 mg/kg |
Conforms |
|
|
|
Arsenic |
≤1.0 mg/kg |
Conforms |
|
|
|
Mercury |
≤1.0 mg/kg |
Conforms |
|
|
|
Total Plate Count |
≤1000.0 |
Conforms |
|
|
|
Yeast and Mold |
≤100 |
Conforms |
|
|
|
Salmonella |
Negative |
Conforms |
|
|
|
E.Coli |
Negative |
Conforms |
|
|
|
Staphylococcus Aureus |
Negative |
Conforms |
|
|
|
Coliform |
≤100 cfu/g |
Conforms |
|
|
|
Conclusion |
The batch product complies with USP 41 Standard |
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