Product Name

Amikacin Sulphate

Batch No.

230626

MFG. Date

Jun.26,2023

Exp Date

Jun.25,2025

Quantity

200bou

Packing

5BOU/Tin;2Tin/Carton

Standard

USP35

ITEMS

SPECIFICATIONS

RESULTS

Description and solubility

A white ,crystalline powder ,very soluble in water

Complies

Identification

Positive reaction

Complies

Specific rotation

+76^o-+84^o

+79^o

Crystallinity

Meets the requirements

Complies

PH

2.0-4.0

3.6

Loss on drying

Not more than 13.0%

10.0%

Residue on ignition

Not more than 1.0%

0.1%

Assay

Anhydrous potency content of C₂₂H₄₃N₃O₁₃ 674-786ug/mg

Anhydrous potency 718ug/mg

Conclusion

Conforming to USP35