Doxycycline Hyclate Tablets
» Doxycycline Hyclate Tablets contain the equivalent of not less than 90.0 percent and not more than 120.0 percent of the labeled amount of doxycycline (C22H24N2O8).
Packaging and storage— Preserve in tight, light-resistant containers.
Identification— Shake a suitable quantity of finely ground Tablets with methanol to obtain a solution containing the equivalent of 1 mg of doxycycline per mL, and filter. Using the filtrate as the Test Solution, proceed as directed for Method II under Identification—Tetracyclines 193.
Dissolution 711
Medium: water; 900 mL.
Apparatus 2: 75 rpm, the distance between the blade and the inside bottom of the flask being maintained at 4.5 ± 0.5 cm during the test.
Time: 90 minutes.
Procedure— Determine the amount of C22H24N2O8 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 Doxycycline Hyclate RS in the same medium.
Tolerances— Not less than 85% (Q) of the labeled amount of C22H24N2O8 is dissolved in 90 minutes.
Uniformity of dosage units 905: meet the requirements.
Water, Method I 921: not more than 5.0%.
Mobile phase, Diluent, Resolution solution, Standard preparation, and Chromatographic system Proceed as directed in the Assay under Doxycycline Hyclate.
Assay preparation— Weigh and finely powder not less than 20 Tablets. Transfer an accurately weighed portion of the powder, equivalent to about 100 mg of doxycycline, to a 100-mL volumetric flask, add about 75 mL of Diluent, sonicate for 5 minutes, shake for 15 minutes, dilute with Diluent to volume, and mix. Filter through a membrane filter of 0.5 µm or finer porosity.
Procedure— Proceed as directed for Procedure in the Assay under Doxycycline Hyclate. Calculate the quantity, in mg, of doxycycline (C22H24N2O8) in the portion of Tablets taken by the formula:
0.1CP(rU / rS)
in which C is the concentration, in mg per mL, of USP Doxycycline Hyclate RS in the Standard preparation, P is the designated potency, in µg of doxycycline per mg, of USP Doxycycline Hyclate RS, and rU and rS are the peak responses obtained from the Assay preparation and the Standard preparation, respectively.
Auxiliary Information— Please check for your question in the FAQs before contacting USP.
Topic/Question Contact Expert Committee
Monograph Ahalya Wise, M.S.
(MDANT05) Monograph Development-Antibiotics
Reference Standards Lili Wang, Technical Services Scientist
711 Margareth R.C. Marques, Ph.D.
Senior Scientist
(BPC05) Biopharmaceutics05
USP32–NF27 Page 2215
Chromatographic Column—
Chromatographic columns text is not derived from, and not part of, USP 32 or NF 27.