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BP, USP
Ampicillin Sodium Sterile, Ampicillin Sodium Non Sterile
CAS number： 69-52-3
Molecular formula： C16H18N3NaO4S
Molecular weight：371.39
Packing: 25kg/drum or 7kg/tin, 2tins/carton
Valid time: 2 years
Test Items | Acceptance Criteria | Test Results |
Characters | White or almost white powder. | Whiter crystalline powder |
Solubility | Freely soluble in water | Complies |
Specific Optical Rotation |
+258°~+287° |
+274° |
Identification | The principal spot in the chromatogram obtained with the test solution is similar in position, colour and size to the principal spot in the chromatogram obtained with the reference solution. | Complies |
Infrared absorption: corresponding to reference standard | Complies | |
Chemical Reaction | Positive | |
Sodium Reaction | Positive | |
pH | 8.0-10.0 | 9.2 |
Appearance of Solution | Not more opalescent than reference suspension II; The absorbance of the solution in water measured at 430nm is not greater than 0.15 | Clear 0.08 |
Related Substances | Ampicillin dimer not more than 4.5% | 3.4% |
Any other individual impurity not more than 2.0% | 0.61% | |
Methylene Chloride | not more than 0.2% | 0.004% |
Specification:
2-ethylhexoic acid | Not more than 0.8% | Complies |
N,N-Dimethylaniline | Not more than 20ppm | 0 |
Water | Not more than 2.0% | 0.5% |
Heavy Metals | Not more than 20ppm | Complies |
Insoluble Particles | ≥ 10mm, ≤ 6000/g | 1300 |
≥ 25mm, ≤ 600/g | 110 | |
Bacterial Endotoxins | Less than 0.15 IU/mg | Complies |
Sterility | Meet the requirements | Complies |
Assay | 91.0%-100.5%, calculated as sodium on anhydrous basis | 91.9% |
Conclusion | conform fully with the standard of BP2009 | |
Functions & Applications
Pharmacodynamics Amoxicillin is a β-lactam type of antimicrobials, broad-spectrum antibacterial effect. Antibacterial spectrum and antibacterial activity and ampicillin basic same, for the majority of gram-positive bacteria, slightly weaker than the antibacterial activities of penicillin enzyme is sensitive to penicillin, so the resistance to penicillin staphylococcus aureus is null and void.On gram-negative bacteria, such as e. coli, proteus, salmonella, haemophilus, brucella and pasteurella has strong function, but these bacteria are prone to resistance.
Is not sensitive to pseudomonas aeruginosa.Because of its absorption in the single stomach animals better than ampicillin, blood drug concentration is higher, so the systemic infection curative effect is better.Suitable for sensitive bacteria caused by respiratory system, urinary system, skin and soft tissue such as systemic infection.
Pharmacokinetic Amoxicillin quite stable with hydrochloric acid in gastric juice, the single stomach animals internal and 74% ~ 92% after being absorbed. Gastrointestinal contents affect the absorption rate, but does not affect the degree of absorption, it can mix feeding.Equivalent dose internal and amoxicillin after the serum concentration of 1.5 ~ 3 times higher than ampicillin.
Oral API is one of the most widely used oral penicillins at present. Its preparations include capsules, tablets, granules, dispersible tablets, and so on. Penicillin allergy and penicillin skin test positive patients are forbidden.
Ampicillin Sodium Sterile, Ampicillin Sodium Non Sterile
CAS number： 69-52-3
Molecular formula： C16H18N3NaO4S
Molecular weight：371.39
Packing: 25kg/drum or 7kg/tin, 2tins/carton
Valid time: 2 years
Test Items | Acceptance Criteria | Test Results |
Characters | White or almost white powder. | Whiter crystalline powder |
Solubility | Freely soluble in water | Complies |
Specific Optical Rotation |
+258°~+287° |
+274° |
Identification | The principal spot in the chromatogram obtained with the test solution is similar in position, colour and size to the principal spot in the chromatogram obtained with the reference solution. | Complies |
Infrared absorption: corresponding to reference standard | Complies | |
Chemical Reaction | Positive | |
Sodium Reaction | Positive | |
pH | 8.0-10.0 | 9.2 |
Appearance of Solution | Not more opalescent than reference suspension II; The absorbance of the solution in water measured at 430nm is not greater than 0.15 | Clear 0.08 |
Related Substances | Ampicillin dimer not more than 4.5% | 3.4% |
Any other individual impurity not more than 2.0% | 0.61% | |
Methylene Chloride | not more than 0.2% | 0.004% |
Specification:
2-ethylhexoic acid | Not more than 0.8% | Complies |
N,N-Dimethylaniline | Not more than 20ppm | 0 |
Water | Not more than 2.0% | 0.5% |
Heavy Metals | Not more than 20ppm | Complies |
Insoluble Particles | ≥ 10mm, ≤ 6000/g | 1300 |
≥ 25mm, ≤ 600/g | 110 | |
Bacterial Endotoxins | Less than 0.15 IU/mg | Complies |
Sterility | Meet the requirements | Complies |
Assay | 91.0%-100.5%, calculated as sodium on anhydrous basis | 91.9% |
Conclusion | conform fully with the standard of BP2009 | |
Functions & Applications
Pharmacodynamics Amoxicillin is a β-lactam type of antimicrobials, broad-spectrum antibacterial effect. Antibacterial spectrum and antibacterial activity and ampicillin basic same, for the majority of gram-positive bacteria, slightly weaker than the antibacterial activities of penicillin enzyme is sensitive to penicillin, so the resistance to penicillin staphylococcus aureus is null and void.On gram-negative bacteria, such as e. coli, proteus, salmonella, haemophilus, brucella and pasteurella has strong function, but these bacteria are prone to resistance.
Is not sensitive to pseudomonas aeruginosa.Because of its absorption in the single stomach animals better than ampicillin, blood drug concentration is higher, so the systemic infection curative effect is better.Suitable for sensitive bacteria caused by respiratory system, urinary system, skin and soft tissue such as systemic infection.
Pharmacokinetic Amoxicillin quite stable with hydrochloric acid in gastric juice, the single stomach animals internal and 74% ~ 92% after being absorbed. Gastrointestinal contents affect the absorption rate, but does not affect the degree of absorption, it can mix feeding.Equivalent dose internal and amoxicillin after the serum concentration of 1.5 ~ 3 times higher than ampicillin.
Oral API is one of the most widely used oral penicillins at present. Its preparations include capsules, tablets, granules, dispersible tablets, and so on. Penicillin allergy and penicillin skin test positive patients are forbidden.
