| 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.
|