Tetracycline Hydrochloride for Injection
»Tetracycline Hydrochloride for Injection is sterile Tetracycline Hydrochloride or a sterile,dry mixture of sterile Tetracycline Hydrochloride,one form of which contains Magnesium Chloride or magnesium ascorbate and one or more suitable buffers,and may contain one or more suitable preservatives,solubilizers,stabilizers,and anesthetic agents,and the other form of which contains one or more suitable stabilizing agents.It contains not less than 90.0percent and not more than 115.0percent of the labeled amount of C22H24N2O8.HCl.
Packaging and storage— Preserve in Containers for Sterile Solidsas described under Injections á1ñ,protected from light.
Labeling— Label Tetracycline Hydrochloride for Injection that contains an anesthetic agent to indicate that it is intended for intramuscular administration only.
Constituted solution— At the time of use,it meets the requirements for Constituted Solutionsunder Injections á1ñ.
Identification— The chromatogram of the Assay preparationobtained as directed in the Assayexhibits a major peak for tetracycline,the retention time of which corresponds to that exhibited in the chromatogram of the Standard preparationobtained as directed in the Assay.
Bacterial endotoxins á85ñ— It contains not more than 0.5USP Endotoxin Unit per mg of tetracycline hydrochloride.
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 2.0and 3.0,in a solution containing 10mg 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 5.0%of its weight.
Particulate matter á788ñ: meets the requirements for small-volume injections.
Limit of 4-epianhydrotetracycline— Using the Diluting solvent,Chromatographic system,and Procedureset forth in the Assay,chromatograph a Standard solution prepared by dissolving an accurately weighed quantity of USP4-Epianhydrotetracycline Hydrochloride RSin Diluting solventto obtain a solution having a known concentration of about 15µg per mL.Using the chromatogram so obtained and the chromatogram of the Assay preparationobtained as directed in the Assay,calculate the percentage of 4-epianhydrotetracycline hydrochloride in the Tetracycline Hydrochloride for Injection taken by the formula:
(10CE/T)(rU/rS),
in which CEis the concentration,in µg per mL,of USP4-Epianhydrotetracycline Hydrochloride RSin the Standard solution;Tis the quantity,in mg,of tetracycline hydrochloride in the portion of Tetracycline Hydrochloride for Injection taken to prepare the Assay preparation,based on the labeled quantity;and rUand rSare the 4-epianhydrotetracycline peak responses obtained from the Assay preparationand the Standard solution,respectively:not more than 3.0%is found.
Other requirements— It meets the requirements for Uniformity of Dosage Units á905ñand for Labelingunder Injections á1ñ.
Assay—
Diluting solvent,Mobile phase,Standard preparation,Resolution solution,and Chromatographic system —Prepare as directed in the Assayunder Tetracycline Hydrochloride.
Assay preparation 1 (where it is represented as being in a single-dose container)—Constitute Tetracycline Hydrochloride for Injection as directed in the labeling.Withdraw all of the withdrawable contents,using a suitable hypodermic needle and syringe,and dilute quantitatively and stepwise with Diluting solventto obtain a solution containing about 0.5mg of tetracycline hydrochloride per mL.
Assay preparation 2 (where the label states the quantity of tetracycline hydrochloride in a given volume of constituted solution)—Constitute Tetracycline Hydrochloride for Injection as directed in the labeling.Dilute an accurately measured volume of the constituted solution quantitatively with Diluting solventto obtain a solution containing about 0.5mg of tetracycline hydrochloride per mL.
Procedure— Proceed as directed in the Assayunder Tetracycline Hydrochloride.Calculate the quantity,in mg,of C22H24N2O8.HCl withdrawn from the container,or in the portion of constituted solution taken by the formula:
(L/D)(CP/1000)(rU/rS),
in which Lis the labeled quantity,in mg,of C22H24N2O8.HCl in the container,or in the volume of constituted solution taken;Dis the concentration,in mg of tetracycline hydrochloride per mL,of Assay preparation 1or 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 1887
Phone Number:1-301-816-8335