polymyxin B sulfate 1405-20-5 polymyxin B standard solution
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Chemical name: Polymyxin B sulfate (aerosporin)
Description: white crystalline powder.
Quality Standard
TESTS |
SPECIFICATIONS |
Description |
White or almost white powder,hygroscopic |
Identification |
Conforms to standard |
Specific optical rotation |
-78°~-90° |
PH(2%) |
5.0~7.0 |
PH(0.5%) |
5.0~7.5 |
Loss on drying |
≤6.0% |
Phenylalanine |
9.0~12.0% |
Related substances(HPLC) |
Major impurity≤3.0% |
Sum of impurity≤17.0% |
|
Sulphate ash |
≤0.75% |
Suphate |
15.5~17.5% |
Heavy metals |
≤20ppm |
Potency(on the dried basis) |
≥6500IU/mg |
Assay(HPLC,on the dried basis) |
Sum of polymyxin B1,B2,B3 and B1-1≥80% |
Polymyxin B3≤6.0% |
|
Polymyxin B1-1≤15% |
|
Particle size |
99%≤20μm |
90%≤15μm |
|
75%≤10μm |
|
35%≤5μm |
|
Mean diameter≤7μm |
Function
To reduce the development of drug-resistant bacteria and maintain the effectiveness of polymyxin B and other antibacterial drugs, polymyxin B should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.
Polymyxin B sulfate is the sulfate salt of Polymyxins B1 and B2, which are produced by the growth of Bacillus
polymyxa (Prazmowski) Migula (Fam. Bacillacea). It has a potency of not less than 6500 polymyxin B units per mg,
calculated on the anhydrous basis. Polymyxin B sulfate has a bactericidal action against almost all gram-negative
bacilli except the Proteus group.
Polymyxin B sulfate is a drug of choice in the treatment of infections of the urinary tract, meninges, and bloodstream caused by susceptible strains of Ps. aeruginosa. It may also be used topically and subconjunctivally in the treatment of infections of the eye caused by susceptible strains of Ps. aeruginosa.
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