| Artículo |
Estándar |
Resultados de la prueba |
| Identificación |
A.H-NMR:Comply with the structure |
Cumple |
|
B.LC-MS:Comply with the structure |
Cumple |
|
C.The IR spectrum of sample should be identical with that of reference standard; |
Cumple |
|
D.HPLC-ESI-MS
The retention time of the major peak in the chromatogram of the Assay preparation corresponds to that in the chromatogram of the Standard preparation, tal como se obtuvo en el ensayo. |
Cumple |
| Crystallinity |
cumple con los requisitos. |
Cumple |
| Pérdida por secado |
≤2,0% |
0.19% |
| metales pesados |
≤10 ppm |
<10ppm |
| Agua |
≤1,0% |
0.1% |
| Ceniza sulfatada |
≤0,5%, determined on 1.0 gramo. |
0.009% |
| Sustancias relacionadas |
Impurezas no especificadas: for each impurity |
<0.10% |
|
Impureza total |
0.18% |
| Pureza |
≥99,0% |
99.7% |
| Ensayo |
99.0%~101,0% (anhydrous substance). |
99.8% |
| Análisis microbiológico |
|
|
| Recuento total de placas |
≤1000ufc/g |
Cumple |
| Yeast and Moulds |
≤100ufc/g |
Cumple |
| mi. coli. |
Ausente |
Negativo |
| Salmonela |
Ausente |
Negativo |
| S.aureus |
Ausente |
Negativo |
| Almacenamiento |
Preserve in well-closed, light-resistant and airtight containers. |
Cumple |
