Kanamycin Sulfate Capsules
»Kanamycin Sulfate Capsules contain the equivalent of not less than 90.0percent and not more than 115.0percent of the labeled amount of kanamycin (C18H36N4O11).
Packaging and storage— Preserve in tight containers.
Identification—
A: Thin-Layer Chromatographic Identification Test á201ñ—
Adsorbent: 0.25-mm layer of chromatographic silica gel mixture,heated at 110for 1hour and cooled immediately before use.
Test solution— Dissolve a suitable quantity of Capsule contents in water to obtain a solution having a concentration of about 1mg of kanamycin per mL.
Developing solvent system: monobasic potassium phosphate solution (15in 100).
Procedure— Proceed as directed in the chapter.Allow the spots to dry,and develop the chromatogram in a suitable chamber,previously equilibrated for 18hours with Developing solvent system.Remove the plate from the chamber,and air-dry.Spray the plate with a solution of ninhydrin in butyl alcohol (1in 100).Dry the plate at 110for 10minutes,and examine the chromatograms.
B: The retention time of the peak for kanamycin in the chromatogram of the Assay preparationcorresponds to that in the chromatogram of the Standard preparation,as obtained in the Assay.
Dissolution,Procedure for a Pooled Sample á711ñ—
Medium: 0.01Nhydrochloric acid;900mL.
Apparatus 1: 100rpm.
Time: 45minutes.
Procedure— Determine the amount of kanamycin (C18H36N4O11)dissolved by employing the procedure set forth in the Assay,making any necessary modifications.
Tolerances— Not less than 75%(Q)of the labeled amount of C18H36N4O11is dissolved in 45minutes.
Loss on drying á731ñ— Dry about 100mg in a capillary-stoppered bottle in vacuum at 60for 3hours:it loses not more than 4.0%of its weight.
Assay—
Mobile phase,Resolution solution,Standard preparation,andChromatographic system— Proceed as directed in the Assayunder Kanamycin Sulfate.
Assay preparation— Remove,as completely as possible,the contents of not fewer than 10Capsules,and mix.Transfer an accurately weighed quantity of the mixed contents,equivalent to about 80mg of kanamycin,to a 250-mLvolumetric flask,add about 50mLof water,and swirl to dissolve.Dilute with water to volume,and mix.Transfer 5.0mLof this solution to a second 250-mLvolumetric flask,dilute with water to volume,and mix.
Procedure— Proceed as directed in the Assayunder Kanamycin Sulfate.Calculate the quantity,in mg,of kanamycin (C18H36N4O11)in the portion of Capsules taken by the formula:
125CP(rU/rS),
in which the terms are as defined therein.
Auxiliary Information— Staff Liaison:William W.Wright,Ph.D.,Scientific Fellow
Expert Committee:(PA7)Pharmaceutical Analysis 7
USP28–NF23Page 1095
Pharmacopeial Forum:Volume No.30(1)Page 120
Phone Number:1-301-816-8335
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