Amoxicillin, an organic compound with the chemical formula C16H19N3O5S, is one of the most commonly used semi-synthetic penicillin-based broad-spectrum β-lactam antibiotics, amoxicillin has a strong bactericidal effect and a strong ability to penetrate cell membranes.
Amoxicillin is suitable for the following infections caused by sensitive bacteria (strains that do not produce beta-lactamase) :
1, hemolytic streptococcus, streptococcus pneumoniae, staphylococcus or haemophilus influenzae caused by otitis media, sinusitis, pharyngitis, tonsillitis and other upper respiratory tract infections;
2. Urogenital tract infection caused by Escherichia coli, Proteus mirabilis or Enterococcus faecalis;
3. Skin and soft tissue infections caused by hemolytic streptococcus, staphylococcus or Escherichia coli;
4. Lower respiratory tract infections such as acute bronchitis and pneumonia caused by hemolytic streptococcus, streptococcus pneumoniae, Staphylococcus or Haemophilus influenzae;
5, acute simple gonorrhea;
6, can be used to treat typhoid fever, other salmonella infections, typhoid carriers and leptospirosis; Amoxicillin can also be combined with clarithromycin and Lansoprazole to eradicate Helicobacter pylori in stomach and duodenum and reduce the recurrence rate of gastrointestinal ulcer.
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Tests | Zvinotsanangurwa | Results | |
Chitarisiko | White or almost white powder, hygroscopic | Almost white powder, hygroscopic | |
Identification | (l)HPLC: positive | Positive | |
(2) Reaction (b) of potassium: positive | Positive | ||
(3) Reaction of cellulose: positive | Positive | ||
pH | 4.8 - 8.0 | 5.7 | |
Polymeric impurities and other impurities absorbing at 278 nm | NMT 0.40 | 0.033 | |
Water | NMT2.5% | 0.46% | |
Related substances | Impurity E: NMT 1.0% | 0.014% | |
Impurity G: NMT 1.0% | 0.0017% | ||
Any other single impurity (major): NMT 0.10% | <0.05% | ||
Total impurities: NMT 2.0% | 0.016% | ||
Assay (HPLC) | 91.2% ~107.1% (as content of potassium clavulanate stated on the label) | 100.4% | |
CLAV.ACID(as is)38.3%~45.0% | 42.1% | ||
CLAV. POT. (as is)45.6%~53.5% | 50.2% | ||
Mhedziso | Conforms to the requirements of EP. |
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