COLISTIN SULPHATE EP4

Test Items

Specification

Characteristic

White or almost white powder

Identification

To meet EP specification

pH Value

4.0～6.0

Loss on drying

≤3.5

Specific optical rotation

-63°～-73°

Sulphate Ash

≤1.0%

Sulphate

16.0～18.0%

Potency(Moisture basis)

-------------

Potency(Dried basis)

≥19000 IU/mg

COLISTIN SULPHATE EP6

Test Items

Specification

Characteristic

White or almost white powder

Identification

To meet EP specification

pH Value

4.0～6.0

Loss on drying

≤3.5

Specific optical rotation

-63°～-73°

Sulphate Ash

≤1.0%

Sulphate

16.0～18.0%

Concent (Dry Basis HPLC)

Colistin E1-I:                   ≤10%

Colistin E1-7MOA:             ≤10%

Colistin E3:                    ≤10%

E1+E2+E3+E1-I+E1-7MOA:    ≥77.0%

Related Substances

Any impurity:                  ≤4.0%

Total impurity:                 ≤23.0%