Doxycycline Hyclate Tablets
»Doxycycline Hyclate Tablets contain the equivalent of not less than 90.0percent and not more than 120.0percent 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 1mg of doxycycline per mL,and filter.Using the filtrate as the Test Solution,proceed as directed for Method IIunder Identification—Tetracyclines á193ñ.
Dissolution á711ñ
Medium: water;900mL.
Apparatus 2: 75rpm,the distance between the blade and the inside bottom of the flask being maintained at 4.5±0.5cm during the test.
Time: 90minutes.
Procedure— Determine the amount of C22H24N2O8dissolved from UVabsorbances at the wavelength of maximum absorbance at about 276nm 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 RSin the same medium.
Tolerances— Not less than 85%(Q)of the labeled amount of C22H24N2O8is dissolved in 90minutes.
Uniformity of dosage units á905ñ: meet the requirements.
Water,Method Iá921ñ: not more than 5.0%.
Assay—
Mobile phase,Diluent,Resolution solution,Standard preparation,andChromatographic system Proceed as directed in the Assayunder Doxycycline Hyclate.
Assay preparation— Weigh and finely powder not less than 20Tablets.Transfer an accurately weighed portion of the powder,equivalent to about 100mg of doxycycline,to a 100-mLvolumetric flask,add about 75mLof Diluent,sonicate for 5minutes,shake for 15minutes,dilute with Diluentto volume,and mix.Filter through a membrane filter of 0.5µm or finer porosity.
Procedure— Proceed as directed for Procedurein the Assayunder 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 Cis the concentration,in mg per mL,of USP Doxycycline Hyclate RSin the Standard preparation,Pis the designated potency,in µg of doxycycline per mg,of USP Doxycycline Hyclate RS,and rUand rSare the peak responses obtained from the Assay preparationand the Standard preparation,respectively.
Auxiliary Information— Staff Liaison:William W.Wright,Ph.D.,Scientific Fellow
Expert Committee:(PA7)Pharmaceutical Analysis 7
USP28–NF23Page 701
Phone Number:1-301-816-8335