U.S. PHARMACOPEIA

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Oxytetracycline for Injection
» Oxytetracycline for Injection contains an amount of Oxytetracycline Hydrochloride equivalent to not less than 90.0 percent and not more than 115.0 percent of the labeled amount of oxytetracycline (C22H24N2O9).
Packaging and storage— Preserve in Containers for Sterile Solids as described under Injections 1, protected from light.
Constituted solution— At the time of use, it meets the requirements for Constituted Solutions under Injections 1.
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, Fluid D being used instead of Fluid A.
pH 791: between 1.8 and 2.8, in a solution containing 25 mg per mL.
Loss on drying 731— Dry about 100 mg, accurately weighed, in a capillary-stoppered bottle in vacuum at a pressure not exceeding 5 mm of mercury at 60 for 3 hours: it loses not more than 3.0% of its weight.
Particulate matter 788: meets the requirements for small-volume injections.
Residual solvents 467: meets the requirements.
(Official January 1, 2007)
Other requirements— It responds to Identification test B under Oxytetracycline Hydrochloride. It also meets the requirements for Uniformity of Dosage Units 905 and Labeling under Injections 1.
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 1 (where it is represented as being in a single-dose container)—Constitute Oxytetracycline for Injection in a volume of water, accurately measured, corresponding to the volume of solvent specified in the labeling. Withdraw all of the withdrawable contents, using a suitable hypodermic needle and syringe, and dilute quantitatively with 0.01 N hydrochloric acid to obtain a solution having a concentration of about 0.2 mg of oxytetracycline per mL.
Assay preparation 2 (where the label states the quantity of oxytetracycline in a given volume of constituted solution)—Constitute Oxytetracycline for Injection in a volume of water, accurately measured, corresponding to the volume of solvent specified in the labeling. Dilute an accurately measured volume of the constituted solution quantitatively with 0.01 N hydrochloric acid to obtain a solution having a concentration of about 0.2 mg of oxytetracycline per mL.
Procedure— Proceed as directed for Procedure in the Assay under Oxytetracycline. Calculate the quantity, in mg, of oxytetracycline (C22H24N2O9) withdrawn from the container or in the portion of constituted solution taken by the formula:
(L / D)(CP)(rU / rS),
in which L is the labeled quantity, in mg, of oxytetracycline (C22H24N2O9) in the container or in the portion of constituted solution taken; D is the concentration, in mg per mL, of oxytetracycline in Assay preparation 1 or in Assay preparation 2, based on the labeled quantity in the container or in the portion of constituted solution taken, respectively, and the extent of dilution; 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 1619
Phone Number : 1-301-816-8223