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 90.0percent and not more than 120.0percent 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 50mg of oxytetracycline,add 50mLof methanol,and shake.Using the clear solution so obtained as the Test Solution,proceed as directed for Method IIunder Identification—Tetracyclines á193ñ.
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.
pHá791ñ: between 8.0and 9.0.
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— Transfer an accurately measured volume of Injection,equivalent to about 100mg of oxytetracycline,to a 500-mLvolumetric flask,dilute with 0.01Nhydrochloric acid to volume,and mix.
Procedure— Proceed as directed for Procedurein the Assayunder Oxytetracycline.Calculate the quantity,in mg,of C22H24N2O9in each mLof the Injection taken by the formula:
0.5(CP/V)(rU/rS),
in which Cis the concentration,in mg per mL,of USP Oxytetracycline RSin the Standard preparation;Vis the volume,in mL,of Injection taken to prepare the Assay preparation;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 1448
Phone Number:1-301-816-8335
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