Test items | Specification | Test Result |
Appearance | White or off-white powder | White powder |
I dentification | H PLC retention time of sample should be concordant with that of reference standard. | Conforms |
1 H NMR spectrum of sample corresponds to that of standard preparation | Conforms | |
HPLC Purity | NLT 99.5% | 99.6% |
Relative substance | Any Individual Impurity ≤0.10% | 0.07% |
Total Impurity ≤0.50% | 0.40% | |
Residue Ignition | ≤0.20% | 0.06% |
Heavy Metals | ≤20ppm | Conforms |
Water | ≤0.50% | 0.15% |
Assay | 98.00%-102.00% | 99.3% |
M icrobial Limit | T otal aerobic bacteria NMT 1000cfu/g | Conforms |
T otal number of moulds and yeast NMT 100cfu/g | Conforms | |
B acterial Endotoxin | N MT 0.5EU/mg | Conforms |
Conclusive | The above result is qualified as the enterprise standard | |
S torage | Preserve in well closed container, store in a cool and dry place, and keep away from strong light and heat. When the product stored under above condition, the retest date is 1years from the manufacture date. |
The End |