(am'' i kay' sin sul' fate).
d-Streptamine, O-3-amino-3-deoxy--d-glucopyranosyl(1®6)-O-[6-amino-6-deoxy--d-glucopyranosyl-(1®4)]-N1-(4-amino-2-hydroxy-1-oxobutyl)-2-deoxy-, (S)-, sulfate (1:2 or 1:1.8) (salt).
O-3-Amino-3-deoxy--d-glucopyranosyl-(1®4)-O-[6-amino-6-deoxy--d-glucopyranosyl-(1®6)]-N3-(4-amino-l-2-hydroxybutyryl)-2-deoxy-l-streptamine sulfate (1:2 or 1:1.8) [39831-55-5].
» Amikacin Sulfate having a molar ratio of amikacin to H2SO4 of 1:2 contains the equivalent of not less than 674 µg and not more than 786 µg of amikacin (C22H43N5O13) per mg, calculated on the dried basis; Amikacin Sulfate having a molar ratio of amikacin to H2SO4 of 1:1.8 contains the equivalent of not less than 691 µg and not more than 806 µg of amikacin (C22H43N5O13) per mg, calculated on the dried basis.
Packaging and storage Preserve in tight containers.
Labeling Label it to indicate whether its molar ratio of amikacin to H2SO4 is 1:2 or 1:1.8.
USP Reference standards 11
Identification It responds to the Identification tests under Amikacin.
Specific rotation 781S: between +76 and +84.
Test solution: 20 mg per mL, in water.
Crystallinity 695: meets the requirements.
pH 791: between 2.0 and 4.0 (1:2 salt), or between 6.0 and 7.3 (1:1.8 salt), in a solution containing 10 mg per mL.
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.
Residue on ignition 281: not more than 1.0%, the charred residue being moistened with 2 mL of nitric acid and 5 drops of sulfuric acid.
Mobile phase, System suitability solution, Standard preparation, and Chromatographic system Proceed as directed in the Assay under Amikacin.
Assay preparation 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.
Procedure Proceed as directed in the Assay under Amikacin. Calculate the quantity, in µg, of amikacin (C22H43N5O13) 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.
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USP35NF30 Page 2160Pharmacopeial Forum: Volume No. 37(4)