Methacycline Hydrochloride Oral Suspension
»Methacycline Hydrochloride Oral Suspension contains the equivalent of not less than 90.0percent and not more than 125.0percent of the labeled amount of methacycline (C22H22N2O8).It contains one or more suitable and harmless buffers,colors,diluents,dispersants,flavors,and preservatives.
Packaging and storage— Preserve in tight,light-resistant containers.
Identification— To an accurately measured volume of Oral Suspension,equivalent to about 50mg of methacycline,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.
Uniformity of dosage units á905ñ—
FOR SUSPENSION PACKAGED IN SINGLE-UNIT CONTAINERS: meets the requirements.
Deliverable volume á698ñ: meets the requirements.
pHá791ñ: between 6.5and 8.0.
Assay—
Mobile phase ,System suitability preparation,and Chromatographic system—Proceed as directed in the Assayunder Methacycline Hydrochloride.
Standard preparation— Transfer about 28mg of USP Methacycline Hydrochloride RS,accurately weighed,to a 50-mLvolumetric flask,add 10mLof water,dilute with Mobile phaseto volume,and mix.
Assay preparation— Transfer an accurately measured quantity of Oral Suspension,freshly mixed and free from air bubbles,equivalent to about 50mg of methacycline (C22H22N2O8),to a 100-mLvolumetric flask,dilute with Mobile phaseto volume,mix,and filter.
Procedure— Proceed as directed in the Assayunder Methacycline Hydrochloride.Calculate the quantity,in mg,of methacycline (C22H22N2O8)in each mLof the Oral Suspension taken by the formula:
100(CE/1000V)(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 1233
Phone Number:1-301-816-8335