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POLYMYXIN B SULFATE

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Detailed Product Description

POLYMYXIN B SULFATE CAS#1405-20-5 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 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 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.

ITEMS	SPECIFICATIONS
DESCRIPTION	WHITE OR ALMOST WHITE POWDER, HYGROSCOPIC
IDENTIFICATION	CONFORMS
PH (2%)	5.0∼7.0
PH (5%)	5.0∼7.5
SPECIFIC ROTATION	-78°∼ -90°
PHENYLALANINE	9∼12%
LOSS ON DRYING	NOT MORE THAN 6.0%
SULPHATED ASH	NOT MORE THAN 0.75%
SULPHATE	15.5∼17.5%
RELATED SUBSTANCES (BY HPLC)	MAJOR IMPUIRITY: NOT MORE THAN 3.0% TOTAL IMPURITIES: NOT MORE THAN 17.0%
HEAVY METALS	NOT MORE THAN 20PPM
ASSAY (AS IS)	NOT LESS THAN 6500 IU/MG
ASSAY HPLC (ODB)	SUM OF POLYMYXINS B1, B2, B3 AND B1-1: NOT LESS THAN 80.0% POLYMYXIN B3: NOT MORE THAN 6.0% POLYMYXIN B1-1: NOT MORE THAN 15.0%
PARTICLE SIZE	99.0%: NOT MORE THAN 20UM BY VOL. 90.0%: NOT MORE THAN 15UM BY VOL. 75.0%: NOT MORE THAN 10UM BY VOL. 35.0%: NOT MORE THAN 5UM BY VOL. MEAN DIAMETER: NOT MORE THAN 7.0UM