CERTIFICATE OF ANALYSIS

Product: AMIKACIN SULPHATE

Batch . . . . . . : YA1911020 Quantity . . . . . . . : 200.00 KGR

MFG. Date . . . . : November 2019 Expiry Date . . . . . : November 2022

T E S T SPECIFICATIONS RESULTS

DESCRIPTION White crystalline powder Conforms

SOLUBILITY Freely soluble in water Conforms

IDENTIFICATION IR: similar to the reference standard Conforms

HPLC: similar to the reference standard Conforms
Reaction of sulfates Conforms

OPTICAL ROTATION +76° to +84° +80°

CRYSTALLINITY Shows birefringence and extinction Conforms

positions

PH 2.0 - 4.0 3.5

LOSS ON DRYING Not more than 13.0 % 9.5 %

RESIDUE ON IGNITION Not more than 1.0 % 0.05 %

RESIDUAL SOLVENTS Methanol: not more than 0.3 % 0.18 %

Ethanol: not more than 0.5 % Undetectable
Acetone: not more than 0.5 % Undetectable
Acetonitrile: not more than 0.041 % Undetectable

BACTERIAL ENDOTOXINS Not more than 0.33 EU/mg Less than 0.33 EU/mg

ASSAY (ON DRY BASIS) 674 - 786 µg/mg 726 µg/mg

REMARKS This product complies with USP42 .

The above data results have been received from the Quality Control Dept.

Technical Director Signature