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 (C
18H
36N
4O
11) 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.
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 (C
18H
36N
4O
11) in the portion of Capsules taken by the formula:
125CP(rU / rS),
in which the terms are as defined therein.
