Demeclocycline Oral Suspension, chemical structure, molecular formula, Reference Standards

Demeclocycline Oral Suspension

»Demeclocycline Oral Suspension contains the equivalent of not less than 90.0percent and not more than 125.0percent of the labeled amount of demeclocycline hydrochloride (C21H21ClN2O8·HCl).It may contain one or more suitable buffers,preservatives,stabilizers,and suspending agents.

Packaging and storage— Preserve in tight containers,protected from light.

USP Reference standards á11ñ— USP Demeclocycline Hydrochloride RS.

Identification— To an accurately measured volume of Oral Suspension,equivalent to about 50mg of demeclocycline hydrochloride,add 50mLof methanol,shake,and allow the mixture to settle.Using the clear supernatant as the Test Solution,proceed as directed for Method IIunder Identification—Tetracyclines á193ñ.

Add the following:

Uniformity of dosage units á905ñ—

FOR ORAL SUSPENSION PACKAGED IN SINGLE-UNIT CONTAINERS: meets the requirements.

USP28

Add the following:

Deliverable volume á698ñ—

FOR ORAL SUSPENSION PACKAGED IN MULTIPLE-UNIT CONTAINERS: meets the requirements.

USP28

pHá791ñ: between 4.0and 5.8.

Assay—

Mobile phase,Standard preparation,Resolution solution,and Chromatographic system— Prepare as directed in the Assayunder Demeclocycline.

Assay preparation— Transfer an accurately weighed quantity of Oral Suspension,freshly mixed and free from air bubbles,equivalent to about 50mg of demeclocycline hydrochloride (C21H21ClN2O8·HCl),to a 50-mLvolumetric flask,dilute with 0.01Nhydrochloric acid to volume,and mix.Sonicate for 5minutes,and centrifuge for 5minutes.Pass a portion of the supernatant through a suitable filter of 1.5-µm or finer porosity,and use the clear filtrate as the Assay preparation.

Procedure— Proceed as directed for Procedurein the Assay under Demeclocycline.Calculate the quantity,in mg,of demeclocycline hydrochloride (C21H21ClN2O8·HCl)equivalent in each mLof Oral Suspension taken by the formula:

0.05(CE/V)(rU/rS),

in which Vis the volume,in mL,of Oral Suspension taken;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 578

Pharmacopeial Forum:Volume No.30(1)Page 92

Phone Number:1-301-816-8335