Methacycline Hydrochloride Oral Suspension
»Methacycline Hydrochloride Oral Suspension contains the equivalent of not less than 90.0 percent and not more than 125.0 percent 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 50 mg of methacycline, add 50 mL of methanol, shake, and allow the mixture to settle. Using the clear supernatant as the Test Solution, proceed as directed for Method II under IdentificationTetracyclines 193.
Uniformity of dosage units 905
for suspension packaged in single-unit containers: meets the requirements.
Deliverable volume 698: meets the requirements.
pH 791: between 6.5 and 8.0.
Mobile phase, System suitability preparation, and Chromatographic system Proceed as directed in the Assay under Methacycline Hydrochloride.
Standard preparation Transfer about 28 mg of USP Methacycline Hydrochloride RS, accurately weighed, to a 50-mL volumetric flask, add 10 mL of water, dilute with Mobile phase to volume, and mix.
Assay preparation Transfer an accurately measured quantity of Oral Suspension, freshly mixed and free from air bubbles, equivalent to about 50 mg of methacycline (C22H22N2O8), to a 100-mL volumetric flask, dilute with Mobile phase to volume, mix, and filter.
Procedure Proceed as directed in the Assay under Methacycline Hydrochloride. Calculate the quantity, in mg, of methacycline (C22H22N2O8) in each mL of the Oral Suspension taken by the formula:
100(CE / 1000V)(rU / rS)in which V is the volume, in mL, of Oral Suspension taken to prepare the Assay preparation; and the other terms are as defined therein.
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USP32NF27 Page 2913