Minocycline Hydrochloride Oral Suspension
» Minocycline Hydrochloride Oral Suspension contains the equivalent of not less than 90.0 percent and not more than 130.0 percent 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.
USP Reference standards 11—
USP Minocycline Hydrochloride RS Click to View Structure
Identification— The retention time of the major peak in the chromatogram of the Assay preparation corresponds to that of the Standard preparation obtained as directed in the Assay.
Uniformity of dosage units 905—
for suspension packaged in single-unit containers: meets the requirements.
Deliverable volume 698: meets the requirements.
pH 791: between 7.0 and 9.0.
Assay—
Mobile phase and Chromatographic system—Proceed as directed in the Assay under Minocycline Hydrochloride.
Standard preparation— Dissolve an accurately weighed quantity of USP Minocycline Hydrochloride RS in Mobile phase to obtain a solution having a known concentration of about 500 µg of minocycline (C23H27N3O7) per mL. Use this solution within 1 hour.
Resolution solution— Prepare a solution in water containing 2 mg of USP Minocycline Hydrochloride RS per mL. Transfer 5 mL of this solution to a small beaker, and heat on a steam bath for 60 minutes. Evaporate to dryness, dissolve the residue in about 25 mL of Mobile phase, and filter.
Assay preparation— Transfer an accurately measured quantity of Oral Suspension, freshly mixed and free from air bubbles, equivalent to about 50 mg of C23H27N3O7, to a 100-mL volumetric flask, dilute with Mobile phase to volume, mix, and filter. Use this solution within 1 hour.
Procedure— Proceed as directed for Procedure in the Assay under Minocycline Hydrochloride. Calculate the quantity, in mg, of C23H27N3O7 in each mL of the Oral Suspension taken by the formula:
0.1(C / V)(rU / rS)
in which V is the volume, in mL, of Oral Suspension taken, and the other terms are as defined therein.
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Topic/Question Contact Expert Committee
Monograph Ahalya Wise, M.S.
Senior Scientific Liaison
1-301-816-8161		 (SM12010) Monographs - Small Molecules 1
Reference Standards RS Technical Services
1-301-816-8129
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USP35–NF30 Page 3928