Oxytetracycline Calcium Oral Suspension, chemical structure, molecular formula, Reference Standards

Oxytetracycline Calcium Oral Suspension

»Oxytetracycline Calcium Oral Suspension contains the equivalent of not less than 90.0percent and not more than 120.0percent of the labeled amount of oxytetracycline (C22H24N2O9).It contains one or more suitable buffers,colors,flavors,preservatives,stabilizers,and suspending agents.In addition,it may contain N-acetylglucosamine.

Packaging and storage— Preserve in tight,light-resistant containers.

USP Reference standards á11ñ— USP Oxytetracycline RS.

Identification— Shake a suitable quantity of Oral Suspension with methanol to obtain a solution containing 1mg of oxytetracycline per mL,and filter.Using the filtrate 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.

Deliverable volume á698ñ: meets the requirements.

pHá791ñ: between 5.0and 8.0.

Assay— Transfer an accurately measured quantity of Oral Suspension,freshly mixed and free from air bubbles,equivalent to about 150mg of oxytetracycline,to a 1000-mLvolumetric flask,dilute with 0.1Nhydrochloric acid to volume,and mix.Proceed as directed for oxytetracycline under Antibiotics—Microbial Assays á81ñ,using an accurately measured volume of this 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.

Auxiliary Information— Staff Liaison:William W.Wright,Ph.D.,Scientific Fellow

Expert Committee:(PA7)Pharmaceutical Analysis 7

USP28–NF23Page 1450

Phone Number:1-301-816-8335