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Ampicillin Sodium

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  • BP, USP

Ampicillin Sodium Sterile, Ampicillin Sodium Non Sterile

CAS number 69-52-3

Molecular formula C16H18N3NaO4S

Molecular weight371.39

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.

 


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