Oxytetracycline for Injection
»Oxytetracycline for Injection contains an amount of Oxytetracycline Hydrochloride equivalent to not less than 90.0percent and not more than 115.0percent of the labeled amount of oxytetracycline (C22H24N2O9).
Packaging and storage— Preserve in Containers for Sterile Solidsas described under Injections á1ñ,protected from light.
Constituted solution— At the time of use,it meets the requirements for Constituted Solutionsunder Injections á1ñ.
Bacterial endotoxins á85ñ— It contains not more than 0.4USP Endotoxin Unit per mg of oxytetracycline.
Sterility á71ñ— It meets the requirements when tested as directed for Membrane Filtrationunder Test for Sterility of the Product to be Examined,Fluid Dbeing used instead of Fluid A.
pHá791ñ: between 1.8and 2.8,in a solution containing 25mg per mL.
Loss on drying á731ñ— Dry about 100mg,accurately weighed,in a capillary-stoppered bottle in vacuum at a pressure not exceeding 5mm of mercury at 60for 3hours:it loses not more than 3.0%of its weight.
Particulate matter á788ñ: meets the requirements for small-volume injections.
Other requirements— It responds to Identificationtest Bunder Oxytetracycline Hydrochloride.It also meets the requirements for Uniformity of Dosage Units á905ñand Labelingunder Injections á1ñ.
Assay—
Tetrabutylammonium hydrogen sulfate solution,Edetate disodium solution,pH7.5Phosphate buffer,Mobile phase,Standard preparation,System suitability solution,and Chromatographic system— Proceed as directed in the Assayunder 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 0.01Nhydrochloric acid to obtain a solution having a concentration of about 0.2mg 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 0.01Nhydrochloric acid to obtain a solution having a concentration of about 0.2mg of oxytetracycline per mL.
Procedure— Proceed as directed for Procedurein the Assayunder 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 Lis the labeled quantity,in mg,of oxytetracycline (C22H24N2O9)in the container or in the portion of constituted solution taken;Dis the concentration,in mg per mL,of oxytetracycline in Assay preparation 1or 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:William W.Wright,Ph.D.,Scientific Fellow
Expert Committee:(PA7)Pharmaceutical Analysis 7
USP28–NF23Page 1451
Phone Number:1-301-816-8335