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Product Name |
Ceftriaxone Sodium Sterile |
CAS No. |
74578-69-1 |
EINECS |
277-930-0 |
Molecular Formula |
C18H16N8Na2O7S3 |
Grade |
Pharmaceutical |
Standard |
USP, BP, CP |
ITEMS |
SPECIFICATION |
RESULTS |
Appearance |
White to pale yellow Crystalline Powder |
Passed |
Identification |
IR Spectrum
HPLC RT
Sodium |
Passed
Passed
Passed |
Clarity |
≤1%Clarty standard solution |
0.5% |
Crystallinity |
Meets the requirements |
Passed |
PH |
6.0~8.0 |
6.5 |
Water |
8.0%~11.0% |
9.6% |
Sterility |
Sterile |
Passed |
Bacterial Endotoxins |
NMT 0.20 USP EU/mg |
Passed |
Acetone |
≤0.5% |
0.05% |
Viable matter |
≤5 |
Passed |
Particulate matter |
≥10um NMT 6000
≥25 um NMT 600 |
Passed
Passed |
Assay (HPLC) |
≥795ug/mg (as Ceftriaxone, anhydrous) |
935ug/mg |
Storage Condition |
Preserve in tight container |