85960-17-4 Imipenem Cilastatin Sodium Imipenem with cilastatin
Item |
Standard |
|
Structural data confirmation |
1. H-NMR: The data of structure are identical with reference standard |
|
2. HPLC-MS: Ensure the molecular weight of main peak and fragment peak are identical with reference standard |
||
3. IR:The data of IR are identical with that of reference standard |
||
Purity(HPLC) |
≥99.0% |
|
Related impurities |
Specific single impurity |
Meets EP/USP/BP standards |
Non-specific single impurity |
≤0.10% |
|
Total Impurities |
≤0.50% |
|
Crystal form |
Meets EP/USP/BP standards |
|
Loss on drying |
≤1.0% |
|
Water |
≤1.0% |
|
Inorganic salt |
≤0.1% |
|
Heavy metals |
≤10 ppm |
|
Assay |
99.0%~101.0%(According to EP/USP/BP standards) |
|
Microbiological Analysis |
||
Total plate count |
≤1000cfu/g |
|
Yeast and Moulds |
≤100cfu/g |
|
E. Coli. |
Absent |
|
Salmonella |
Absent |
|
S.aureus |
Absent |
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