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621
) coated with a 0.25-mm layer of chromatographic silica gel having an average pore size of 6 nm. [NOTE—Dilute the Injection with water, if necessary, to obtain a test solution containing 1000 µg of gentamicin per mL. Where the Injection contains less than 1000 µg per mL, apply a volume of it, equivalent to 20 µg of gentamicin, to the chromatographic plate, in separate portions of not more than 20 µL each, each application being allowed to dry before the next is applied.] Place the plate in a suitable chromatographic chamber, and develop the chromatogram in a solvent system consisting of the lower phase of a mixture of chloroform, methanol, and ammonium hydroxide (20:13:10) until the solvent front has moved about three-fourths of the length of the plate. Remove the plate from the chamber, air-dry, and expose the plate to vapors of iodine in a detection jar containing iodine crystals: the intensities and RF values of the three principal spots obtained from the test solution correspond to those obtained from the Standard solution.
85—
It contains not more than 0.71 USP Endotoxin Unit per mg of gentamicin.
791:
between 3.0 and 5.5.
788:
meets the requirements for small-volume injections.
467:
meets the requirements.
1.
81, using an accurately measured volume of Injection diluted quantitatively and stepwise with Buffer No. 3 to yield a Test Dilution having a concentration assumed to be equal to the median dose level of the Standard (0.1 µg of gentamicin per mL).