Items | Specifications | Result | |
Appearance | White or almost white powder,hygroscopic. | Conforms | |
Solubility | Soluble in water.slightly soluble in alcohol. | Conforms | |
ldentification | A:The retention times of the major peaks from thesample solution correspond to 'those of thestandard solution,as obtained in the test forcomposition of Polymyxins. B: To the sample solution add 5ml of 2.5N sodiumhydroxide,and mix,Add 5 drops of 10mg/ml ofcupric sulfate shaking after the addition of eachdrop,A reddish-violet color is produced. C: lt gives reaction of sulphate. | Conforms | |
PH | 5.0-7.5 | 5.4 | |
Loss on drying | NMT7.0% | 3.0% | |
Residue on ignition | NMT5.0% | 0.20% | |
On the dried basis | Not less than 6000IU/mg | 8254IU/mg | |
Related substances | Any impurity | NMT3.0% | 1.8% |
Total impurity | 17.0% | 4.1% | |
Compositionof Polymyxins | B3 | NMT6.0% | 1.4% |
B1-1 | NMT15.0% | 8.1% | |
Sum of B1,B2,B3 and B1-l | NMT80.0% | 94.0% | |
Conlusion | The results conform to the standard of USP43 |
MOQ | 50G |
BY air | Any airport in china |
By sea | Any seaport in china |
By courier | / |