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 90.0 percent and not more than 115.0 percent of the labeled amount of C22H24N2O8.HCl.
Packaging and storage— Preserve in Containers for Sterile Solids as described under Injections 1, 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 Solutions under Injections 1.
Identification— The chromatogram of the Assay preparation obtained as directed in the Assay exhibits a major peak for tetracycline, the retention time of which corresponds to that exhibited in the chromatogram of the Standard preparation obtained as directed in the Assay.
Bacterial endotoxins 85— It contains not more than 0.5 USP Endotoxin Unit per mg of tetracycline hydrochloride.
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 2.0 and 3.0, in a solution containing 10 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 5.0% of its weight.
Particulate matter 788: meets the requirements for small-volume injections.
Limit of 4-epianhydrotetracycline— Using the Diluting solvent, Chromatographic system, and Procedure set forth in the Assay, chromatograph a Standard solution prepared by dissolving an accurately weighed quantity of USP 4-Epianhydrotetracycline Hydrochloride RS in Diluting solvent to obtain a solution having a known concentration of about 15 µg per mL. Using the chromatogram so obtained and the chromatogram of the Assay preparation obtained 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 CE is the concentration, in µg per mL, of USP 4-Epianhydrotetracycline Hydrochloride RS in the Standard solution; T is 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 rU and rS are the 4-epianhydrotetracycline peak responses obtained from the Assay preparation and the Standard solution, respectively: not more than 3.0% is found.
Other requirements— It meets the requirements for Uniformity of Dosage Units 905 and for Labeling under Injections 1.
Assay—
Diluting solvent, Mobile phase, Standard preparation, Resolution solution, and Chromatographic system —Prepare as directed in the Assay under 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 solvent to obtain a solution containing about 0.5 mg 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 solvent to obtain a solution containing about 0.5 mg of tetracycline hydrochloride per mL.
Procedure— Proceed as directed in the Assay under Tetracycline Hydrochloride. Calculate the quantity, in mg, of C22H24N2 O8.HCl withdrawn from the container, or in the portion of constituted solution taken by the formula:
(L / D)(CP / 1000)(rU / rS)
in which L is the labeled quantity, in mg, of C22H24N2O8.HCl in the container, or in the volume of constituted solution taken; D is the concentration, in mg of tetracycline hydrochloride per mL, of Assay preparation 1 or 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— Please check for your question in the FAQs before contacting USP.
Topic/Question Contact Expert Committee
Monograph Ahalya Wise, M.S.
Scientist
1-301-816-8161		 (MDANT05) Monograph Development-Antibiotics
Reference Standards Lili Wang, Technical Services Scientist
1-301-816-8129
RSTech@usp.org
85 Radhakrishna S Tirumalai, Ph.D.
Senior Scientist
1-301-816-8339		 (MSA05) Microbiology and Sterility Assurance
71 Radhakrishna S Tirumalai, Ph.D.
Senior Scientist
1-301-816-8339		 (MSA05) Microbiology and Sterility Assurance
USP32–NF27 Page 3696
Chromatographic Column—
Chromatographic columns text is not derived from, and not part of, USP 32 or NF 27.