Oxytetracycline and Nystatin for Oral Suspension
»Oxytetracycline and Nystatin for Oral Suspension is a dry mixture of Oxytetracycline and Nystatin with one or more suitable buffers,colors,diluents,flavors,suspending agents,and preservatives.When constituted as directed in the labeling,it contains not less than 90.0percent and not more than 120.0percent of the labeled amount of oxytetracycline (C22H24N2O9),and not less than 90.0percent and not more than 135.0percent of the labeled amount of USP Nystatin Units.
Packaging and storage— Preserve in tight,light-resistant containers,at controlled room temperature.
Identification— To a quantity of Oxytetracycline and Nystatin for Oral Suspension (powder),equivalent to about 50mg of oxytetracycline,add 50mLof methanol,shake,and allow the mixture to settle.Using the clear supernatant as the Test Solution,proceed as directed for Method IIunder Identification—Tetracyclines á193ñ.
Uniformity of dosage units á905ñ—
FOR SOLID PACKAGED IN SINGLE-UNIT CONTAINERS: meets the requirements for Content Uniformitywith respect to oxytetracycline and nystatin.
Deliverable volume á698ñ: meets the requirements.
pHá791ñ: between 4.5and 7.5,in the suspension constituted as directed in the labeling.
Water,Method Iá921ñ: not more than 2.0%.
Assay for oxytetracycline— Constitute Oxytetracycline and Nystatin for Oral Suspension as directed in the labeling.Transfer an accurately measured volume of the suspension so obtained,freshly mixed and free from air bubbles,to a suitable volumetric flask,dilute with 0.1Nhydrochloric acid to volume so that the stock solution so obtained contains not less than 150µg of oxytetracycline per mL,and mix.Proceed as directed for oxytetracycline under Antibiotics—Microbial Assays á81ñ,using an accurately measured volume of the stock solution diluted quantitatively and stepwise with water to yield a Test Dilutionhaving a concentration assumed to be equal to the median dose level of the Standard.
Assay for nystatin— Constitute Oxytetracycline and Nystatin for Oral Suspension as directed in the labeling.Transfer an accurately measured volume of the suspension so obtained,freshly mixed and free from air bubbles,to a blender jar containing a sufficient,accurately measured volume of dimethylformamide to yield a solution of convenient concentration,and blend at high speed for 3to 5minutes.Dilute an accurately measured volume of this solution quantitatively with dimethylformamide to obtain a stock solution containing about 400USP Nystatin Units per mL.Proceed as directed for nystatin under Antibiotics—Microbial Assays á81ñ,using an accurately measured volume of this solution diluted quantitatively with Buffer No.6to yield a Test Dilutionhaving a concentration of nystatin assumed to be equal to the median dose level of the Standard.
Auxiliary Information— Staff Liaison:William W.Wright,Ph.D.,Scientific Fellow
Expert Committee:(PA7)Pharmaceutical Analysis 7
USP28–NF23Page 1449
Phone Number:1-301-816-8335