Amikacin Sulfate
C22H43N5O13·2H2SO4
781.76
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.
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.
Assay
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.
Auxiliary Information
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Chromatographic Column
USP32NF27 Page 1509
Chromatographic columns text is not derived from, and not part of, USP 32 or NF 27.
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