U.S. PHARMACOPEIA

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Oxytetracycline Calcium Oral Suspension
» Oxytetracycline Calcium Oral Suspension contains the equivalent of not less than 90.0 percent and not more than 120.0 percent 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.
Identification— Shake a suitable quantity of Oral Suspension with methanol to obtain a solution containing 1 mg of oxytetracycline per mL, and filter. Using the filtrate 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.
Deliverable volume 698: meets the requirements.
pH 791: between 5.0 and 8.0.
Residual solvents 467: meets the requirements.
(Official January 1, 2007)
Assay— Transfer an accurately measured quantity of Oral Suspension, freshly mixed and free from air bubbles, equivalent to about 150 mg of oxytetracycline, to a 1000-mL volumetric flask, dilute with 0.1 N hydrochloric acid to volume, and mix. Proceed as directed for oxytetracycline under Antibiotics—Microbial Assays 81, using an accurately measured volume of this 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.
Auxiliary Information— Staff Liaison : Brian D. Gilbert, Ph.D., Scientist
Expert Committee : (MDANT05) Monograph Development-Antibiotics
USP29–NF24 Page 1618
Phone Number : 1-301-816-8223