Chloramphenicol Ophthalmic Solution
» Chloramphenicol Ophthalmic Solution is a sterile solution of Chloramphenicol. It contains not less than 90.0 percent and not more than 130.0 percent of the labeled amount of C11H12Cl2N2O5.
Packaging and storage—
Preserve in tight containers, and store in a refrigerator until dispensed. The containers or individual cartons are sealed and tamper-proof so that sterility is assured at time of first use.
Labeling—
The labeling states that there is a 21-day beyond-use period after dispensing.
Identification—
The retention time of the major peak in the chromatogram of the Assay preparation corresponds to that in the chromatogram of the Standard preparation as obtained in the Assay.
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 7.0 and 7.5, except that in the case of Ophthalmic Solution that is unbuffered or is labeled for veterinary use it is between 3.0 and 6.0.
791:
between 7.0 and 7.5, except that in the case of Ophthalmic Solution that is unbuffered or is labeled for veterinary use it is between 3.0 and 6.0.
Assay—
Standard preparation—
Dissolve an accurately weighed quantity of USP Chloramphenicol RS in Mobile phase, and dilute quantitatively, and stepwise if necessary, with Mobile phase to obtain a solution having a known concentration of about 100 µg per mL. Filter a portion of this solution through a 0.5-µm or finer porosity filter, and use the clear filtrate as the Standard preparation.
Assay preparation—
Transfer an accurately measured volume of Ophthalmic Solution, equivalent to about 50 mg of chloramphenicol, to a 100-mL volumetric flask, dilute with Mobile phase to volume, and mix. Transfer 5.0 mL of the resulting solution to a 25-mL volumetric flask, dilute with Mobile phase to volume, and mix. Filter a portion of this solution through a 0.5-µm or finer porosity filter, and use the clear filtrate as the Assay preparation.
Procedure—
Proceed as directed for Procedure in the Assay under Chloramphenicol. Calculate the quantity, in mg, of C11H12Cl2N2O5 in each mL of the Ophthalmic Solution taken by the formula:
0.5(C / V)(rU / rS)
in which V is the volume, in mL, of Ophthalmic Solution taken, and the other terms are as defined therein.
Auxiliary Information—
Please check for your question in the FAQs before contacting USP.
Chromatographic Column—
| 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 1887
Chromatographic columns text is not derived from, and not part of, USP 32 or NF 27.