U.S. PHARMACOPEIA

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Oxytetracycline Injection
» Oxytetracycline Injection is a sterile solution of Oxytetracycline with or without one or more suitable anesthetics, antioxidants, buffers, complexing agents, preservatives, and solvents. It contains the equivalent of not less than 90.0 percent and not more than 120.0 percent of the labeled amount of Oxytetracycline (C22H24N2O9).
Packaging and storage— Preserve in single-dose or multiple-dose containers, protected from light.
Identification— To an accurately measured volume of Injection, equivalent to about 50 mg of oxytetracycline, add 50 mL of methanol, and shake. Using the clear solution so obtained as the Test Solution, proceed as directed for Method II under Identification—Tetracyclines 193.
Bacterial endotoxins 85— It contains not more than 0.4 USP Endotoxin Unit per mg of oxytetracycline.
Sterility 71— It meets the requirements when tested as directed for Membrane Filtration under Test for Sterility of the Product to be Examined.
pH 791: between 8.0 and 9.0.
Residual solvents 467: meets the requirements.
(Official January 1, 2007)
Assay—
Tetrabutylammonium hydrogen sulfate solution, Edetate disodium solution, pH 7.5 Phosphate buffer, Mobile phase, Standard preparation, System suitability solution, and Chromatographic system— Proceed as directed in the Assay under Oxytetracycline.
Assay preparation— Transfer an accurately measured volume of Injection, equivalent to about 100 mg of oxytetracycline, to a 500-mL volumetric flask, dilute with 0.01 N hydrochloric acid to volume, and mix.
Procedure— Proceed as directed for Procedure in the Assay under Oxytetracycline. Calculate the quantity, in mg, of C22H24N2O9 in each mL of the Injection taken by the formula:
0.5(CP / V)(rU / rS),
in which C is the concentration, in mg per mL, of USP Oxytetracycline RS in the Standard preparation; V is the volume, in mL, of Injection taken to prepare the Assay preparation; and the other terms are as defined therein.
Auxiliary Information— Staff Liaison : Brian D. Gilbert, Ph.D., Scientist
Expert Committee : (MDANT05) Monograph Development-Antibiotics
USP29–NF24 Page 1616
Phone Number : 1-301-816-8223