| Articolo |
Standard |
Risultati del test |
| Identificazione |
A.H-NMR:Comply with the structure |
Conforme |
|
B.LC-MS:Comply with the structure |
Conforme |
|
C.The IR spectrum of sample should be identical with that of reference standard; |
Conforme |
|
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, as obtained in the Assay. |
Conforme |
| Crystallinity |
meets the requirements. |
Conforme |
| Perdita all'essiccamento |
≤2,0% |
0.19% |
| Metalli pesanti |
≤10 ppm |
<10ppm |
| Acqua |
≤1,0% |
0.1% |
| Ceneri solfatate |
≤0,5%, determined on 1.0 g. |
0.009% |
| Related substances |
Impurezze non specificate: for each impurity |
<0.10% |
|
Total Impurity |
0.18% |
| Purezza |
≥99,0% |
99.7% |
| Saggio |
99.0%~101.0% (anhydrous substance). |
99.8% |
| Analisi microbiologica |
|
|
| Conteggio totale della piastra |
≤1000cfu/g |
Conforme |
| Yeast and Moulds |
≤100ufc/g |
Conforme |
| e. Coli. |
Absent |
Negativo |
| Salmonella |
Absent |
Negativo |
| S.aureus |
Absent |
Negativo |
| Magazzinaggio |
Preserve in well-closed, light-resistant and airtight containers. |
Conforme |
