Polymyxin
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ITEMS |
SPECIFICATION |
RESULTS |
DESCRIPTION |
WHITE TO ALMOST WHITE POWDER, HYGROSCOPIC. |
CONFORMS |
SOLUBILITY |
FREELY SOLUBLE IN WATER; SLIGHTLY SOLUBLE IN ALCOHOL. |
CONFORMS |
IDENTIFICATION |
A. LIQUID CHROMATOGRAPHIC IDENTIFICATION TEST B. A REDDISH VIOLET COLOR IS PRODUCED C. TEST FOR SULFATE |
CONFORMS |
PH(2%) |
5.0~7.0 |
5.7 |
PH(0.5%) |
5.0~7.5 |
5.5 |
SPECIFIC ROTATION |
-78°- -90° |
-80.0° |
LOSS ON DRYING |
NOT MORE THAN 7.0% |
4.7% |
PHENYLALANINE |
9.0%~12.0% |
10.31% |
SULPHATED ASH |
NOT MORE THAN 0.75% |
0.31% |
SULPHATE |
15.5%~17.5% |
16.53% |
HEAVY METALS |
NOT MORE THAN 20PPM |
<20PPM |
ASSAY(MICROBIAL) (ON DRIED BASIS) |
NOT LESS THAN 6500IU/MG |
8220 IU/MG |
PARTICLE SIZE |
99.0%:NOT MORE THAN 30UM BY VOL. 90.0%:NOT MORE THAN 25UM BY VOL. 75.0%:NOT MORE THAN 20UM BY VOL. MEAN DIAMETER:NOT MORE THAN 8.0UM |
CONFORMS |
CONCLUSION:THE RESULTS CONFORM TO THE STANDARD OF USP34 |
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