Kanamycin Sulfate Capsules
» Kanamycin Sulfate Capsules contain the equivalent of not less than 90.0 percent and not more than 115.0 percent of the labeled amount of kanamycin (C18H36 N4O11).
Packaging and storage— Preserve in tight containers.
A: Thin-Layer Chromatographic Identification Test 201
Adsorbent: 0.25-mm layer of chromatographic silica gel mixture, heated at 110 for 1 hour 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 1 mg of kanamycin per mL.
Developing solvent system: monobasic potassium phosphate solution (15 in 100).
Procedure— Proceed as directed in the chapter. Allow the spots to dry, and develop the chromatogram in a suitable chamber, previously equilibrated for 18 hours with Developing solvent system. Remove the plate from the chamber, and air-dry. Spray the plate with a solution of ninhydrin in butyl alcohol (1 in 100). Dry the plate at 110 for 10 minutes, and examine the chromatograms.
B: The retention time of the peak for kanamycin in the chromatogram of the Assay preparation corresponds to that in the chromatogram of the Standard preparation, as obtained in the Assay.
Dissolution, Procedure for a Pooled Sample 711
Medium: 0.01 N hydrochloric acid; 900 mL.
Apparatus 1: 100 rpm.
Time: 45 minutes.
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 C18H36N4O11 is dissolved in 45 minutes.
Loss on drying 731 Dry about 100 mg in a capillary-stoppered bottle in vacuum at 60 for 3 hours: it loses not more than 4.0% of its weight.
Mobile phase, Resolution solution, Standard preparation, and Chromatographic system— Proceed as directed in the Assay under Kanamycin Sulfate.
Assay preparation— Remove, as completely as possible, the contents of not fewer than 10 Capsules, and mix. Transfer an accurately weighed quantity of the mixed contents, equivalent to about 80 mg of kanamycin, to a 250-mL volumetric flask, add about 50 mL of water, and swirl to dissolve. Dilute with water to volume, and mix. Transfer 5.0 mL of this solution to a second 250-mL volumetric flask, dilute with water to volume, and mix.
Procedure— Proceed as directed in the Assay under 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— Please check for your question in the FAQs before contacting USP.
Topic/Question Contact Expert Committee
Monograph Ahalya Wise, M.S.
(MDANT05) Monograph Development-Antibiotics
Reference Standards Lili Wang, Technical Services Scientist
711 Margareth R.C. Marques, Ph.D.
Senior Scientist
(BPC05) Biopharmaceutics05
USP32–NF27 Page 2735
Pharmacopeial Forum: Volume No. 30(1) Page 120
Chromatographic Column—
Chromatographic columns text is not derived from, and not part of, USP 32 or NF 27.