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Polymyxin B Sulfate is a white or almost white powder, the efficacy ingredient is polymyxin B sulfate. Clinically, it is mainly used for infection and inflammation caused by sensitive bacteria and Pseudomonas aeruginosa.
Specification
TESTS SPECIFICATIONS
Description White or almost white powder
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%
Application
-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 stronglysuspected 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 subconjunctivallyin the treatment of infections of the eye caused by susceptible strains of Ps. aeruginosa.
Packing
25 kgs/ fiber drum