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Polymixin-B-Sulphate

Product name: Polymixin-B-Sulphate
CAS: 1405-20-5
化学品名: Xylometazoline
Category: Pharmaceutical Intermediates
Specification:
Items
Specifications
Appearance
White or less white powder,
PH(2%) 
PH(0.5%)  
5.0-7.0
5.0-7.5
Sulphated ash 
0.75%
Specific rotation
                       -78°~-90°
Sulphate
15.5-17.5%
Loss on drying
≤6.0%
Residue on ignition
≤0.1%
Heavy metals
≤20ppm
Phenylalanine  
9.0-12.0%
Total viabel aerobic count  
≤10cfu/g
Related sunstances,HPLC
Major impurity
Total impurity
≤3.0%
 ≤17.0%
Assay ,microbiological(as is)
≥6500IU/mg
5um of polymyxins B1,B2,B3 and B1-1
Polymyxin B3
Polymyxin B1-1
≥80.0%
≤6.0%
≤15.0%
Particle size  
≥99.0% ≤20um by vol
≥90.0% ≤15um by vol
≥75.0%≤10um by vol
≥35.0%≤5um by vol
Conclusion It complies with  the USP31.
 
 
Contactor: