Manufacturer Provide High Quality for Amoxicillin and Clavulanate Potassium 4: 1
Introduction
Amoxicillin potassium clavulanate is suitable for production β- Lactamase, lower respiratory tract infection, otitis media and sinusitis caused by Haemophilus influenzae and Moraxella catarrhalis; yield β- Lactamase Staphylococcus aureus and enzyme producing Enterobacteriaceae, such as urinary tract, skin and soft tissue infection caused by Escherichia coli and Klebsiella; It can also be used for mild and moderate infection caused by Enterococcus. This product can also be used for various infections caused by non enzyme producing strains in the above bacteria. This product is white or almost white suspension particles, fragrant and sweet. Amoxicillin potassium clavulanate is a compound preparation. Its components are amoxicillin and potassium clavulanate, which are used under the guidance of doctors.
Amoxicillin clavulanate potassium is suitable for various infections caused by sensitive bacteria, such as:
1. Upper respiratory tract infection: sinusitis, tonsillitis, pharyngitis, etc.
2. Lower respiratory tract infection: acute bronchitis, acute attack of chronic bronchitis, pneumonia, pulmonary abscess and bronchial co infection, etc.
3. Urinary system infection: cystitis, urethritis, pyelonephritis, prostatitis, pelvic inflammation, Neisseria gonorrhoeae, urinary tract infection and soft chancre.
4. Skin and soft tissue infection: furuncle, abscess, cellulitis, wound infection, abdominal sepsis, etc.
5. Other infections: otitis media, osteomyelitis, sepsis, peritonitis and postoperative infection.
Name of product | Amoxicillin and Clavulanate postassium(4:1) |
Tests | Specifications | Results |
Characters | A white to slightly yellow powder .hygroscopic | A white powder , hygroscopic |
Identification | The retention time of the two major peak in the chromatogram of the Assay preparation corresponds to that exhibited in the chromatogram of the standard preparation. | Conforms |
Water | 9.0% ~12.0% | 10.2% |
PH | 3.5~7.5 | 5.3 |
Related substances | Any impurity ≤2.0% (calculated on the basis of amoxicillin peak areas in the chromatogram of reference solution) | 0.03% |
Total impurities ≤5.0% (calculated on the basis of amoxicillin peak areas in the chromatogram of reference solution) | 0.06% |
Assay | Amoxicillin(C16 H19 N3 O5S)≥695 μg/mg, | Amoxicillin 772 μg/mg |
Clavulanic acid(C8 H9 NO5) ≥ 176μg/mg, | Clavulanic acid 193 μg/mg |
The ratio of Amoxicillin to Clavulanic acid should be 3.6~ 4.4 | 4.0 |