Oxytetracycline for Injection

This article is compiled based on the United States Pharmacopeia (USP) – 2025 Edition

Issued and maintained by the United States Pharmacopeial Convention (USP)

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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).

1 Packaging and storage

Preserve as described in Packaging and Storage Requirements 〈659〉, Injection Packaging, Packaging for constitution, protected from light.

USP Reference standards 〈11〉

USP Oxytetracycline RS

2 Constituted solution

At the time of use, it meets the requirements for Injections and Implanted Drug Products 〈1〉, Specific Tests, Completeness and clarity of solutions.

Bacterial Endotoxins Test 〈85〉 - It contains not more than 0.4 USP Endotoxin Unit per mg of oxytetracycline.

Sterility Tests 〈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 in Injections 〈788〉: meets the requirements for small-volume injections.

3 Other requirements

It responds to Identification test B under Oxytetracycline Hydrochloride. It also meets the requirements for Uniformity of

Dosage Units 〈905〉 and Labeling 〈7〉, Labels and Labeling for Injectable Products.

4 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)(r_U/r_S)

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.