11/2/2020 USP-NF Gentamicin Sulfate Ophthalmic Ointment
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O cial Status: Currently O cial on 02-Nov-2020
O cial Date: O cial as of 1-Aug-2017
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Gentamicin Sulfate Ophthalmic Ointment
DEFINITION
Gentamicin Sulfate Ophthalmic Ointment contains the equivalent of NLT 90.0% and NMT 135.0% of the labeled amount of gentamicin.
IDENTIFICATION
• A. THIN-LAYER CHROMATOGRAPHY
Standard solution: 1 mg/mL of USP Gentamicin Sulfate RS in water
Sample solution: Nominally 1 mg/mL of gentamicin from Ophthalmic Ointment prepared as follows. Shake a quantity of Ophthalmic
Ointment, containing nominally 5 mg of gentamicin, with a mixture of 200 mL of chloroform and 5 mL of water. Allow to separate,
and lter the aqueous layer.
Chromatographic system
(See Chromatography 〈621〉, Thin-Layer Chromatography.)
Adsorbent: 0.25-mm layer of chromatographic silica gel
Application volume: 20 µL
Developing solvent system: Mix chloroform, methanol, and ammonium hydroxide (20:13:10). Allow to separate, and use the lower
layer.
Analysis
Samples: Standard solution and Sample solution
Apply the Standard solution and the Sample solution to the plate. Place the plate in a chromatographic chamber, and develop the
chromatogram in the Developing solvent system until the solvent front has moved three-fourths of the length of the plate.
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Remove the plate, air-dry, and expose it to vapors of iodine in a detection jar containing iodine crystals.
Acceptance criteria: The intensities and RF values of the three principal spots of the Sample solution correspond to those of the
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Standard solution.
ASSAY
• PROCEDURE
(See Antibiotics—Microbial Assays 〈81〉.)
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Sample solution: Shake a portion of Ophthalmic Ointment containing nominally 1 mg of gentamicin with about 50 mL of ether in a
separator, and extract with four 20-mL portions of Buffer B.3 (see the chapter). Combine the buffer extracts, and dilute with Buffer
B.3 to a suitable volume to obtain a Test Dilution with a gentamicin concentration that is nominally equivalent to the median level of
the standard.
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Analysis: Proceed as directed in the chapter.
Acceptance criteria: 90.0%–135.0%
SPECIFIC TESTS
• STERILITY TESTS 〈71〉: Meets the requirements
• OTHER REQUIREMENTS: It meets the requirements for Particulate and Foreign Matter and Container Contents in Ophthalmic Products—
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Quality Tests 〈771〉, Drug Product Quality, Universal Tests, Particulate and Foreign Matter and Container Contents.
ADDITIONAL REQUIREMENTS
• PACKAGING AND STORAGE: Preserve in collapsible ophthalmic ointment tubes. Store at controlled room temperature.
• USP REFERENCE STANDARDS 〈11〉
USP Gentamicin Sulfate RS
Auxiliary Information- Please check for your question in the FAQs before contacting USP.
Topic/Question Contact Expert Committee
GENTAMICIN SULFATE OPHTHALMIC Ying Han BIO42020 Biologics Monographs 4 -
OINTMENT Associate Science & Standards Liaison Antibiotics
Chromatographic Database Information: Chromatographic Database
Most Recently Appeared In:
Pharmacopeial Forum: Volume No. 39(5)
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11/2/2020 USP-NF Gentamicin Sulfate Ophthalmic Ointment
Page Information:
USP43-NF38 - 2102
USP42-NF37 - 2055
USP41-NF36 - 1938
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