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.

USP Reference standards

—
USP Amikacin RS.
USP Kanamycin Sulfate RS.

Identification—

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.

Assay—

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. Scientist 1-301-816-8161	(MDANT05) Monograph Development-Antibiotics
Reference Standards	Lili Wang, Technical Services Scientist 1-301-816-8129 RSTech@usp.org
711	Margareth R.C. Marques, Ph.D. Senior Scientist 1-301-816-8106	(BPC05) Biopharmaceutics05

USP32–NF27 Page 2735

Pharmacopeial Forum: Volume No. 30(1) Page 120

Chromatographic Column—

KANAMYCIN SULFATE CAPSULES

Chromatographic columns text is not derived from, and not part of, USP 32 or NF 27.