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 90.0 percent and not more than 120.0 percent of the labeled amount of oxytetracycline (C22H24N2O9), and not less than 90.0 percent and not more than 135.0 percent of the labeled amount of USP Nystatin Units.
Packaging and storage— Preserve in tight, light-resistant containers, at controlled room temperature.
USP Reference standards 11
USP Nystatin RS Click to View Structure
USP Oxytetracycline RS Click to View Structure
Identification— To a quantity of Oxytetracycline and Nystatin for Oral Suspension (powder), equivalent to about 50 mg of oxytetracycline, add 50 mL of methanol, shake, and allow the mixture to settle. Using the clear supernatant as the Test Solution, proceed as directed for Method II under Identification—Tetracyclines 193.
Uniformity of dosage units 905
for solid packaged in single-unit containers: meets the requirements for Content Uniformity with respect to oxytetracycline and nystatin.
Deliverable volume 698: meets the requirements.
pH 791: between 4.5 and 7.5, in the suspension constituted as directed in the labeling.
Water, Method I 921: 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 0.1 N hydrochloric acid to volume so that the stock solution so obtained contains not less than 150 µg of oxytetracycline per mL, and mix. Proceed as directed for oxytetracycline under Antibiotics—Microbial Assays 81, using an accurately measured volume of the stock solution diluted quantitatively and stepwise with water to yield a Test Dilution having 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 3 to 5 minutes. Dilute an accurately measured volume of this solution quantitatively with dimethylformamide to obtain a stock solution containing about 400 USP Nystatin Units per mL. Proceed as directed for nystatin under Antibiotics—Microbial Assays 81, using an accurately measured volume of this solution diluted quantitatively with Buffer No. 6 to yield a Test Dilution having a concentration of nystatin assumed to be equal to the median dose level of the Standard.
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USP35–NF30 Page 4187