Doxycycline for Oral Suspension, chemical structure, molecular formula, Reference Standards

Doxycycline for Oral Suspension

»Doxycycline for Oral Suspension contains the equivalent of not less than 90.0percent and not more than 125.0percent of the labeled amount of C22H24N2O8when constituted as directed.It contains one or more suitable buffers,colors,diluents,flavors,and preservatives.

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

USP Reference standards á11ñ— USP Doxycycline Hyclate RS.

Identification— To a quantity of Doxycycline for Oral Suspension (powder),equivalent to about 50mg of doxycycline,add 50mLof methanol,shake,and allow to settle.Using the clear supernatant as the Test Solution,proceed as directed for Method IIunder Identification—Tetracyclines á193ñ.

Uniformity of dosage units á905ñ—

FORSOLID PACKAGED IN SINGLE-UNIT CONTAINERS: meets the requirements.

Deliverable volume á698ñ: meets the requirements.

pHá791ñ: between 5.0and 6.5,in the suspension constituted as directed in the labeling.

Water,Method Iá921ñ: not more than 3.0%.

Assay—

Mobile phase,Diluent,Resolution solution,Standard preparation,and Chromatographic system— Proceed as directed in the Assayunder Doxycycline Hyclate.

Assay preparation— Constitute Doxycycline for Oral Suspension as directed in the labeling.Transfer an accurately measured portion of the constituted suspension,freshly mixed and free from air bubbles,equivalent to about 100mg of doxycycline,to a 100-mLvolumetric flask,add 50mLof 0.1Nhydrochloric acid,and shake by mechanical means for about 15minutes.Dilute with Diluentto volume,and mix.Filter through filter paper,discarding the first 10mLof the filtrate,then filter through a filter of 0.5-µm or finer porosity.

Procedure— Proceed as directed for Procedurein the Assayunder Doxycycline Hyclate.Calculate the quantity,in mg of doxycycline (C22H24N2O8),in each mLof the constituted suspension taken by the formula:

0.1(CP/V)(rU/rS),

in which Vis the volume,in mL,of the constituted suspension taken to prepare the Assay preparation,and the other terms are as defined therein.

Auxiliary Information— Staff Liaison:William W.Wright,Ph.D.,Scientific Fellow

Expert Committee:(PA7)Pharmaceutical Analysis 7

USP28–NF23Page 698

Phone Number:1-301-816-8335