1.Ceftriaxone Sodium is an antibiotic useful for the treatment of a number of bacterial infections.
2.Ceftriaxone Sodium is a third-generation cephalosporin.
3.Ear (otitis media caused by Haemophilus influenzae, Moraxella catarrhalis,and S. pyogenes.)
4.Nose, sinuses (sinusitis), Throat (tonsillitis, pharyngitis caused by S. pyogenes )
5.Chest and lungs (bronchitis, pneumonia caused by Streptococcus pneumoniae and Haemophilus influenzae)
Specification:
ITEMS | SPECIFICATION | RESULTS |
Appearance | White to pale yellow Crystalline Powder | Passed |
Identification | IR Spectrum
HPLC RT Sodium |
Passed
Passed Passed |
Clarity | <1Clarty 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. |
Packaging details:
Packaging details: | 25kg/drum with double plastic bags inside; packed in a cardboard drum or fiber HDPE drum. |
Storage: | Stored in a clean, cool, dry area; keep away from moisture and strong, direct light/heat |
Shelf Life: | 5 years if sealed and store away from direct sun light. |
WHITE SWAN PHARMACEUTICAL
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