Tetracycline Hydrochloride Capsules
» Tetracycline Hydrochloride Capsules 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.
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
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; 90 minutes for 500-mg capsules.
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; 90 minutes for 500-mg capsules.
Uniformity of dosage units 905: meet the requirements.
Loss on drying 731 Dry about 100 mg of Capsule contents, 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 4.0% 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 10 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 Capsules 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 Capsules 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 accurately not fewer than 20 Capsules. Empty the Capsule contents into a mortar. Clean and accurately weigh the Capsule shells, and calculate the net weight of the Capsule contents. Mix the powder in the mortar, using a pestle, and transfer an accurately weighed quantity of the freshly mixed powder, equivalent to about 50 mg of tetracycline hydrochloride, to a 100-mL volumetric flask. Add about 50 mL of Diluting solvent, mix, and sonicate for about 5 minutes. Allow to cool, dilute with Diluting solvent to volume, mix, and filter.
Procedure— Proceed as directed in the Assay under Tetracycline Hydrochloride. Calculate the quantity, in mg, of C22H24N2O8·HCl in the portion of Capsules 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.
Scientist
1-301-816-8161
(MDANT05) Monograph Development-Antibiotics
Reference Standards Lili Wang, Technical Services Scientist
1-301-816-8129
RSTech@usp.org
711 Margareth R.C. Marques, Ph.D.
Senior Scientist
1-301-816-8106
(BPC05) Biopharmaceutics05
USP32–NF27 Page 3696
Chromatographic Column—
Chromatographic columns text is not derived from, and not part of, USP 32 or NF 27.