Minocycline Hydrochloride Oral Suspension
»Minocycline Hydrochloride Oral Suspension contains the equivalent of not less than 90.0percent and not more than 130.0percent of the labeled amount of minocycline (C23H27N3O7),and one or more suitable diluents,flavors,preservatives,and wetting agents in an aqueous vehicle.
Packaging and storage— Preserve in tight,light-resistant containers.
Identification— The retention time of the major peak in the chromatogram of the Assay preparationcorresponds to that of the Standard preparationobtained as directed in the Assay.
Uniformity of dosage units á905ñ—
FOR SUSPENSION PACKAGED IN SINGLE-UNIT CONTAINERS: meets the requirements.
Deliverable volume á698ñ: meets the requirements.
pHá791ñ: between 7.0and 9.0.
Assay—
Mobile phase and Chromatographic system—Proceed as directed in the Assayunder Minocycline Hydrochloride.
Standard preparation— Dissolve an accurately weighed quantity of USP Minocycline Hydrochloride RSin Mobile phaseto obtain a solution having a known concentration of about 500µg of minocycline (C23H27N3O7)per mL.Use this solution within 1hour.
Resolution solution— Prepare a solution in water containing 2mg of USP Minocycline Hydrochloride RSper mL.Transfer 5mLof this solution to a small beaker,and heat on a steam bath for 60minutes.Evaporate to dryness,dissolve the residue in about 25mLof Mobile phase,and filter.
Assay preparation— Transfer an accurately measured quantity of Oral Suspension,freshly mixed and free from air bubbles,equivalent to about 50mg of C23H27N3O7,to a 100-mLvolumetric flask,dilute with Mobile phaseto volume,mix,and filter.Use this solution within 1hour.
Procedure— Proceed as directed for Procedurein the Assayunder Minocycline Hydrochloride.Calculate the quantity,in mg,of C23H27N3O7in each mLof the Oral Suspension taken by the formula:
0.1(C/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 1299
Phone Number:1-301-816-8335