Doxycycline Calcium Oral Suspension
» Doxycycline Calcium Oral Suspension is prepared from Doxycycline Hyclate, and contains one or more suitable buffers, colors, diluents, flavors, and preservatives. It contains the equivalent of not less than 90.0 percent and not more than 125.0 percent of the labeled amount of doxycycline (C22H24N2O8).
Packaging and storage— Preserve in tight, light-resistant containers.
USP Reference standards 11—
USP Doxycycline Hyclate RS Click to View Structure
Identification— To an accurately measured volume of Oral Suspension, equivalent to about 50 mg of doxycycline, add 50 mL of methanol, shake, and allow to settle. Using the clear supernatant as the Test Solution, proceed as directed for Method II under Identification—Tetracyclines 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.
Assay—
Mobile phase, Resolution solution, Standard preparation, and Chromatographic system— Proceed as directed in the Assay under Doxycycline Hyclate.
Edetate diluent— Transfer 5.2 g of edetate disodium to a 500-mL volumetric flask, add about 400 mL of Mobile phase, sonicate for about 10 minutes or until dissolved, dilute with Mobile phase to volume, and mix.
Assay preparation— Constitute Oral Suspension as directed in the labeling. Transfer an accurately measured portion of the constituted oral suspension, freshly mixed and free from air bubbles, equivalent to about 100 mg of doxycycline, to a 100-mL volumetric flask, add 50 mL of Edetate diluent, sonicate for 15 minutes, and then shake by mechanical means for about 15 minutes. Dilute with Edetate diluent to volume, and mix. Pass through filter paper, discarding the first 10 mL of the filtrate, then pass through a filter having a 0.5-µm or finer porosity.
Procedure— Proceed as directed for Procedure in the Assay under Doxycycline Hyclate. Calculate the quantity, in mg, of doxycycline (C22H24N2O8) in each mL of the Oral Suspension taken by the formula:
0.1(CP / V)(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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USP35–NF30 Page 2983