Chloramphenicol and Hydrocortisone Acetate for Ophthalmic Suspension
»Chloramphenicol and Hydrocortisone Acetate for Ophthalmic Suspension is a sterile,dry mixture of Chloramphenicol and Hydrocortisone Acetate 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 chloramphenicol (C11H12Cl2N2O5),and not less than 90.0percent and not more than 115.0percent of the labeled amount of hydrocortisone acetate (C23H32O6),when constituted as directed.
Labeling— If packaged in combination with a container of solvent,label it with a warning that it is not for injection.
Identification— The retention times of the major peaks in the chromatogram of the Assay preparationcorrespond 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 suspension containing 5mg of chloramphenicol per mL.
Assay—
Mobile phase and Chromatographic system—Proceed as directed in the Assayunder Chloramphenicol.
Standard preparation— Transfer about 37.5mg of USP Chloramphenicol RSand 37.5Jmg of USP Hydrocortisone Acetate RS,both accurately weighed,Jbeing the ratio of the labeled amount,in mg,of hydrocortisone acetate to the labeled amount,in mg,of chloramphenicol in the Chloramphenicol and Hydrocortisone Acetate for Ophthalmic Solution,to a 100-mLvolumetric flask,add 15mLof water and 75mLof methanol,sonicate for a few seconds,dilute with methanol to 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 Standard preparation.
Assay preparation— Transfer the contents of an accurately counted number of containers of Chloramphenicol and Hydrocortisone Acetate for Ophthalmic Solution,equivalent to about 37.5mg of chloramphenicol,to a 100-mLvolumetric flask with the aid of 5mLof water for each 12.5mg of chloramphenicol contained therein.Wash each container with methanol,and add the washings to the volumetric flask.Dilute with methanol to 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 chloramphenicol (C11H12Cl2N2O5)in each container taken by the formula:
0.5(C/N)(rU/rS),
in which Nis the number of containers taken,and the other terms are as defined therein.Calculate the quantity,in mg,of hydrocortisone acetate (C23H32O6)in each container taken by the formula:
500(C/N)(rU/rS),
in which Cis the concentration,in mg per mL,of USP Hydrocortisone Acetate RSin the Standard preparation,Nis the number of containers taken,and rUand rSare the hydrocortisone acetate peak responses obtained from the Assay preparationand the Standard preparation,respectively.
Auxiliary Information— Staff Liaison:William W.Wright,Ph.D.,Scientific Fellow
Expert Committee:(PA7)Pharmaceutical Analysis 7
USP28–NF23Page 430
Phone Number:1-301-816-8335
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