|
Items
|
Standards
|
|
Appearance
|
White or almost white, hygroscopic powder
|
|
Identification
|
A,B,C,D: Positive
|
|
Specific optical rotation
|
-63° to -73°
|
|
PH
|
4.0-6.0
|
|
Loss on drying
|
3.5% max
|
|
Sulfate (dried basis)
|
16.0-18.0%
|
|
Sulfate ash
|
1.0% max
|
|
Particle size range
|
100% pass 20 mesh sieve(850um)
|
|
Related substances
|
Any impurity: 4.0%max
|
|
Total impurities: 23.0%max
|
|
Composition
(dried substance)
|
Sum of polymyxins: 77.0%min
|
|
E1-I: 10.0%max
|
|
E3: 10.0%max
|
|
E1-7MOA: 10.0%max
|
|
Biological Potency (U/mg)
|
------------
|
|
Biological Potency (U/mg)
(Dried basis)
|
19000 U/mg min
|
>>Alphabetical order
