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 90.0percent and not more than 130.0percent 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.
Identification— The retention time of the major peak in the chromatogram of the Assay preparationcorresponds to that in the chromatogram of the Standard preparationas obtained in the Assay.
Sterility á71ñ— It meets the requirements when tested as directed for Membrane Filtrationunder Test for Sterility of the Product to be Examined.
pHá791ñ: between 7.1and 7.5,in an aqueous solution containing 5mg of chloramphenicol per mL.
Assay—
Mobile phase and Chromatographic system—Proceed as directed in the Assayunder Chloramphenicol.
Standard preparation— Dissolve an accurately weighed quantity of USP Chloramphenicol RSin Mobile phase,and dilute quantitatively,and stepwise if necessary,with Mobile phaseto obtain a solution having a known concentration of about 100µg 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 1container of Chloramphenicol for Ophthalmic Solution to a suitable container with the aid of Mobile phase,and dilute quantitatively,and stepwise if necessary,with Mobile phaseto obtain a solution having a concentration of about 100µg 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 Procedurein the Assayunder Chloramphenicol.Calculate the quantity,in mg,of C11H12Cl2N2O5in the container of Chloramphenicol for Ophthalmic Solution taken by the formula:
(L/D)C(rU/rS),
in which Lis the labeled quantity,in mg,of chloramphenicol in the container,Dis 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.
Auxiliary Information— Staff Liaison:William W.Wright,Ph.D.,Scientific Fellow
Expert Committee:(PA7)Pharmaceutical Analysis 7
USP28–NF23Page 429
Phone Number:1-301-816-8335