Loss on drying 731
Dry about 100 mg, accurately weighed, in vacuum at a pressure not exceeding 5 mm of mercury at 110
for 3 hours: it loses not more than 13.0% of its weight.
Mobile phase, System suitability solution, Standard preparation, and Chromatographic system
Proceed as directed in the Assay under Amikacin.
Transfer an accurately weighed quantity of Amikacin Sulfate, equivalent to about 50 mg of amikacin (C22H43N5O13), to a 250-mL volumetric flask, add about 50 mL of water, and swirl to dissolve. Dilute with water to volume, and mix. Transfer 10.0 mL of this solution to a 100-mL volumetric flask, dilute with water to volume, and mix.
Proceed as directed in the Assay
Calculate the quantity, in µg, of amikacin (C22
) in each mg of Amikacin Sulfate taken by the formula:
2500(CE / W)(rU / rS),
in which W
is the weight, in mg, of Amikacin Sulfate taken to prepare the Assay preparation;
and the other terms are as defined therein.