Shelf Life

3 years

Packing

20kg/drum

ITEM CONTROLLED

STANDARD

Characters

White or almost white Powder

Identification

Conforms to EP specifications

PH-value

4.0~6.0

Loss on drying

=3.5%

Specific optical rotation

-63°~-73°

Sulphated Ash

=1.0%

Sulphate

16.0~18.0%

Concent(Dry Basis HPLC)

Colistin E1-?:=10.0%

Colistin E1-7MOA:=10.0%

Colistin E3:=10.0%

E1+E2+E3+E1-?+E1-7MOA:=77.0%

Related Substances

Any impurity:=4.0%

Total impurity:=23.0%

Potency(Moisted basis)

Potency(Dried basis)

=19000IU/mg

Conclusion

This product complies with EP9.0

Remark

This batch was manufactured in full compliance with EU-GMP guide part ? requirements