China (Mainland)
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- Product Details
Keywords
- Ceftriaxone sodium
- CEFATRIAXONE
- 2,5,6-tetrahydro-2-methyl-5,6-dioxo-)(methoxyimino)acetyl)amino)-8-oxo-3-
Quick Details
- ProName: High Quality Ceftriaxone sodium
- CasNo: 74578-69-1
- Molecular Formula: C18H18N8O7S3
- Appearance: white powder
- Application: API
- DeliveryTime: 3-5 days
- PackAge: 5KG/TIN,2TINS/CTN
- Port: Tianjin
- ProductionCapacity: 10 Metric Ton/Month
- Purity: 99%
- LimitNum: 1 Kilogram
Superiority
|
Product |
Ceftriaxone Sodium(Sterile ) |
Mfg. Date |
2013-01-12 |
|
Batch No. |
130121057 |
Exp. Date |
2015-12 |
|
Analysed as per |
USP31+IH Specification |
Date of Issue |
2013-01-26 |
|
TEST |
SPECIFICATION |
RESULT |
|
Description |
White or almost white crystalline powder |
White crystalline powder |
|
Identification (HPLC ,IR,Sodium test) |
Corresponding |
Complies
|
|
Crystallinity |
Meets the Requirements |
Complies |
|
pH |
6.0~8.0 |
6.6 |
|
Water |
8.0~11.0% |
9.3% |
|
Colour of solution |
Not more than Y7,YG7 or OY7 |
YG4 |
|
Clarity of solution |
Not more than 1# |
0.5# |
|
Related substances(HPLC) |
|
|
|
Largest single impurity |
Not more than 0.5% |
0.1% |
|
Total impurities |
Not more than 1.5% |
0.2% |
|
Bacterial endotoxins |
Less than 0.20Eu/mg |
<0.20Eu/mg |
|
Sterility |
Meets the requirements |
Complies |
|
Particulate matter (per g of Ceftriaxone) |
NMT 3000 for ≥10μm |
<300 per g |
|
NMT 300 for ≥25μm |
<20 per g |
|
|
Assay (on anhydrous basis) |
NLT 795 μg of ceftriaxone per mg |
925μg/ mg
|
|
Conclusion :We certify that the above product complies as per USP31+IH Specification |
||
Details
The drug as a semi-synthetic third-generation cephalosporins, for most Gram-positive bacteria and-negative bacteria have strong antibacterial activity, antibacterial spectrum, including Pseudomonas aeruginosa, Escherichia coli, Klebsiella pneumoniae, Haemophilus influenzae, bacterial intestinal gas production , Proteus, and Staphylococcus aureus meningitis is so. The drug on β-lactamase stability.
The main clinical infection for susceptible strains of meningitis, pneumonia, skin and soft tissue infections, peritonitis, urinary tract infections, gonorrhea, liver and gallbladder infection, surgical trauma, sepsis, and genital infections. As a treatment for gonorrhea has been first-line drugs.