Chloramphenicol for Ophthalmic Solution
» Chloramphenicol for Ophthalmic Solution is a sterile, dry mixture of Chloramphenicol with or without one or more suitable buffers, diluents, and preservatives. It contains not less than 90.0 percent and not more than 130.0 percent of the labeled amount of C11H12Cl2N2O5, when constituted as directed.
Packaging and storage— Preserve in tight containers.
Labeling— If packaged in combination with a container of solvent, label it with a warning that it is not for injection.
USP Reference standards 11
USP Chloramphenicol RS Click to View Structure
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.
pH 791: between 7.1 and 7.5, in an aqueous solution containing 5 mg of chloramphenicol per mL.
Assay—
Mobile phase and Chromatographic system—Proceed as directed in the Assay under Chloramphenicol.
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 the contents of 1 container of Chloramphenicol for Ophthalmic Solution to a suitable container with the aid of Mobile phase, and dilute quantitatively, and stepwise if necessary, with Mobile phase to obtain a solution having a concentration of about 100 µg of chloramphenicol per mL. 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 the container of Chloramphenicol for Ophthalmic Solution taken by the formula:
(L / D)C(rU / rS)
in which L is the labeled quantity, in mg, of chloramphenicol in the container, D is the concentration, in µg per mL, of chloramphenicol in the Assay preparation, based on the labeled quantity and the extent of dilution, and the other terms are as defined therein.
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