Chloramphenicol Ophthalmic Solution
»Chloramphenicol Ophthalmic Solution is a sterile solution of Chloramphenicol.It contains not less than 90.0percent and not more than 130.0percent 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 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 7.0and 7.5,except that in the case of Ophthalmic Solution that is unbuffered or is labeled for veterinary use it is between 3.0and 6.0.
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 an accurately measured volume of Ophthalmic Solution,equivalent to about 50mg of chloramphenicol,to a 100-mLvolumetric flask,dilute with Mobile phaseto volume,and mix.Transfer 5.0mLof the resulting solution to a 25-mLvolumetric flask,dilute with Mobile phaseto 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 Procedurein the Assayunder Chloramphenicol.Calculate the quantity,in mg,of C11H12Cl2N2O5in each mLof the Ophthalmic Solution taken by the formula:
0.5(C/V)(rU/rS),
in which Vis the volume,in mL,of Ophthalmic Solution taken,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