- E-mail : info@cixmechpharma.com
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 |
≤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. |
|
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. |
