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

Doxycycline Calcium Oral Suspension

»Doxycycline Calcium Oral Suspension is prepared from Doxycycline Hyclate,and contains one or more suitable buffers,colors,diluents,flavors,and preservatives.It contains the equivalent of not less than 90.0percent and not more than 125.0percent of the labeled amount of doxycycline (C22H24N2O8).

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

USP Reference standards á11ñ— USP Doxycycline Hyclate RS.

Identification— To an accurately measured volume of Oral Suspension,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—

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

Deliverable volume á698ñ: meets the requirements.

pHá791ñ: between 6.5and 8.0.

Assay—

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

Edetate diluent— Transfer 5.2g of edetate disodium to a 500-mLvolumetric flask,add about 400mLof Mobile phase,sonicate for about 10minutes or until dissolved,dilute with Mobile phaseto volume,and mix.

Assay preparation— Constitute Oral Suspension as directed in the labeling.Transfer an accurately measured portion of the constituted oral suspension,freshly mixed and free from air bubbles,equivalent to about 100mg of doxycycline,to a 100-mLvolumetric flask,add 50mLof Edetate diluent,sonicate for 15minutes,and then shake by mechanical means for about 15minutes.Dilute with Edetate diluentto volume,and mix.Pass through filter paper,discarding the first 10mLof the filtrate,then pass through a filter having a 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 Oral Suspension taken by the formula:

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

in which Vis the volume,in mL,of Oral 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