Neomycin and Polymyxin B Sulfates and Bacitracin Zinc Ophthalmic Ointment
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This article is compiled based on the United States Pharmacopeia (USP) – 2025 Edition
Issued and maintained by the United States Pharmacopeial Convention (USP)
1 DEFINITION
Neomycin and Polymyxin B Sulfates and Bacitracin Zinc Ophthalmic Ointment contains the equivalent of NLT 90.0% and NMT 140.0% of the labeled amounts of neomycin, polymyxin B, and bacitracin.
2 IDENTIFICATION
A. THIN-LAYER CHROMATOGRAPHIC IDENTIFICATION TEST (2018NP); Meets the requirements.
3 ASSAY
3.1 NEOMYCIN
(See Antibiotics-Microbial Assays (81).)
Sample solution: Shake a portion of Ophthalmic Ointment in a separator with 50 ml of ether. Extract with four 20-mL portions of Buffer B.3. Combine the aqueous extracts, and dilute with Buffer B.3 to a suitable volume.
Analysis: Proceed as directed in the chapter. Dilute the Sample solution with Buffer B.3 to obtain a Test Dilution having a neomycin. concentration that is nominally equivalent to the median level of the standard.
Acceptance criteria: 90.0%-140.0%
3.2 POLYMYXIN B
(See Antibiotics-Microbial Assays (81))
Sample solution: Shake a portion of Ophthalmic Ointment with 50 mL of ether in a separator. Extract with four 25 mL portions of Buffer B.6.
Combine the aqueous extracts, and dilute with Buffer B.6 to a suitable volume.
Analysis: Proceed as directed in the chapter. Dilute the Sample solution with Buffer B.6 to obtain a Test Dilution having a concentration that is nominally equivalent to the median level of the standard (10 Polymyxin B Units/mL). Add to each Test Dilution of the standard, a quantity of USP Neomycin Sulfate RS, dissolved in Buffer B.6, to obtain the same concentration of neomycin as in the Test Dilution of the sample.
Acceptance criteria: 90.0%-140.0%
3.3 BACITRACIN
(See Antibiotics-Microbial Assays (81))
Sample solution: Shake a portion of Ophthalmic Ointment with 50 mL of ether in a separator. Extract with four 25-mL, portions of 0.01 N bydrochloric acid. Combine the acid extracts, and dilute with 0.01 N hydrochloric acid to a suitable volume.
Analysis: Proceed as directed in the chapter. Dilute the Sample solution with Buffer B.1 to obtain a Test Dilution having a concentration that is nominally equivalent to the median level of the standard (1.0 Bacitracin Unit/mL). If the Sample solution has a concentration of less than 100 Bacitracin Units/mL, add hydrochloric acid to each Test Dilution of the standard to obtain the same concentration of hydrochloric acid as in the Test Dilution of the sample.
Acceptance criteria: 90.0%-140.0%
4 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-Quality Tests (771), Drug Product Quality Universal Tests. Particulate and Foreign Matter and Container Contents
5 ADDITIONAL REQUIREMENTS
PACKAGING AND STORAGE: Preserve in collapsible ophthalmic ointment tubes. Store at controlled room temperature.
USP REFERENCE STANDARDS (11)
USP Bacitracin Zino RS
USP Neotrecin Sulfate RS
ERP Polymyxin Sulfate
