Neomycin and Polymyxin B Sulfates and Gramicidin Ophthalmic Solution
» Neomycin and Polymyxin B Sulfates and Gramicidin Ophthalmic Solution is a sterile, isotonic aqueous solution of Neomycin Sulfate, Polymyxin B Sulfate, and Gramicidin. It contains the equivalent of not less than 90.0 percent and not more than 130.0 percent of the labeled amounts of neomycin, polymyxin B, and gramicidin.
Packaging and storage—
Preserve in tight containers. The containers or individual cartons are sealed and tamper-proof so that sterility is assured at time of first use.
Thin-layer chromatographic identification test 
201BNP
:
meets the requirements.
201BNP:
meets the requirements.
Sterility 71—
It meets the requirements when tested as directed for Membrane Filtration under Test for Sterility of the Product to be Examined.
71—
It meets the requirements when tested as directed for Membrane Filtration under Test for Sterility of the Product to be Examined.
pH 791:
between 4.7 and 6.0.
791:
between 4.7 and 6.0.
Assay for neomycin—
Proceed as directed for neomycin under Antibiotics—Microbial Assays 81, using an accurately measured volume of Ophthalmic Solution 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.
81, using an accurately measured volume of Ophthalmic Solution 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.
Assay for polymyxin B—
Proceed as directed for polymyxin B under Antibiotics—Microbial Assays 81, using an accurately measured volume of Ophthalmic Solution diluted quantitatively and stepwise with Buffer No. 6 to yield a Test Dilution having a concentration assumed to be equal to the median dose level of the Standard. Add to each test dilution of the Standard a quantity of USP Neomycin Sulfate RS, dissolved in Buffer No. 6, to obtain the same concentration of neomycin as is present in the Test Dilution.
81, using an accurately measured volume of Ophthalmic Solution diluted quantitatively and stepwise with Buffer No. 6 to yield a Test Dilution having a concentration assumed to be equal to the median dose level of the Standard. Add to each test dilution of the Standard a quantity of USP Neomycin Sulfate RS, dissolved in Buffer No. 6, to obtain the same concentration of neomycin as is present in the Test Dilution.
Assay for gramicidin—
Proceed as directed for gramicidin under Antibiotics—Microbial Assays 81, using an accurately measured volume of Ophthalmic Solution diluted quantitatively and stepwise with alcohol to yield a Test Dilution having a concentration assumed to be equal to the median dose level of the Standard.
81, using an accurately measured volume of Ophthalmic Solution diluted quantitatively and stepwise with alcohol to yield a Test Dilution having a concentration assumed to be equal to the median dose level of the Standard.
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 |
|
| 71 |
Radhakrishna S Tirumalai, Ph.D.
Senior Scientist 1-301-816-8339 |
(MSA05) Microbiology and Sterility Assurance |
USP32–NF27 Page 3062
Pharmacopeial Forum: Volume No. 28(4) Page 1163