Tetracycline Hydrochloride Tablets

» Tetracycline Hydrochloride Tablets contain not less than 90.0 percent and not more than 125.0 percent of the labeled amount of C22H24N2O8·HCl.

Packaging and storage— Preserve in tight, light-resistant containers.

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USP Tetracycline Hydrochloride RS

USP 4-Epianhydrotetracycline Hydrochloride RS

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.

Dissolution

711

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Medium: water; 900 mL.

Apparatus 2: 75 rpm. Maintain a distance of 45 ± 5 mm between the blade and the inside bottom of the vessel.

Time: 60 minutes.

Procedure— Determine the amount of C22H24N2O8·HCl dissolved from UV absorbances at the wavelength of maximum absorbance at about 276 nm of filtered portions of the solution under test, suitably diluted with Dissolution Medium, if necessary, in comparison with a Standard solution having a known concentration of USP Tetracycline Hydrochloride RS in the same Medium.

Tolerances— Not less than 80% (Q) of the labeled amount of C22H24N2O8·HCl is dissolved in 60 minutes.

Uniformity of dosage units

905

: meet the requirements.

Loss on drying

731

— Dry about 100 mg, accurately weighed, 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.

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 Tablets 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 Tablets 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.

Assay—

Diluting solvent, Mobile phase, Standard preparation, Resolution solution, and Chromatographic system— Prepare as directed in the Assay under Tetracycline Hydrochloride.

Assay preparation— Weigh and finely powder not fewer than 20 Tablets. Transfer an accurately weighed portion of the powder, equivalent to about 50 mg of tetracycline hydrochloride, to a 100-mL volumetric flask, add 50 mL of Diluting solvent, mix, and sonicate for 5 minutes. Allow to cool, add Diluting solvent to volume, mix, and filter.

Procedure— Proceed as directed for Procedure in the Assay under Tetracycline Hydrochloride. Calculate the quantity, in mg, of C22H24N2O8·HCl in the portion of Tablets taken by the formula:

(CP / 10)(rU / rS)

in which the 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. Senior Scientific Liaison 1-301-816-8161	(SM12010) Monographs - Small Molecules 1
Reference Standards	RS Technical Services 1-301-816-8129 rstech@usp.org
711	Margareth R.C. Marques, Ph.D. Senior Scientific Liaison 1-301-816-8106	(GCDF2010) General Chapters - Dosage Forms

USP35–NF30 Page 4816