Demeclocycline Oral Suspension
» Demeclocycline Oral Suspension contains the equivalent of not less than 90.0 percent and not more than 125.0 percent of the labeled amount of demeclocycline hydrochloride (C21H21ClN2O8·HCl). It may contain one or more suitable buffers, preservatives, stabilizers, and suspending agents.
Packaging and storage Preserve in tight containers, protected from light.
USP Reference standards 11
Identification To an accurately measured volume of Oral Suspension, equivalent to about 50 mg of demeclocycline hydrochloride, 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 oral suspension packaged in single-unit containers: meets the requirements.
Deliverable volume 698
for oral suspension packaged in multiple-unit containers: meets the requirements.
pH 791: between 4.0 and 5.8.
Mobile phase, Standard preparation, Resolution solution, and Chromatographic system Prepare as directed in the Assay under Demeclocycline.
Assay preparation Transfer an accurately weighed quantity of Oral Suspension, freshly mixed and free from air bubbles, equivalent to about 50 mg of demeclocycline hydrochloride (C21H21ClN2O8· HCl), to a 50-mL volumetric flask, dilute with 0.01 N hydrochloric acid to volume, and mix. Sonicate for 5 minutes, and centrifuge for 5 minutes. Pass a portion of the supernatant through a suitable filter having a 1.5-µm or finer porosity, and use the clear filtrate as the Assay preparation.
Procedure Proceed as directed for Procedure in the Assay under Demeclocycline. Calculate the quantity, in mg, of demeclocycline hydrochloride (C21H21ClN2O8·HCl) equivalent in each mL of Oral Suspension taken by the formula:
0.05(CE / 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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USP35NF30 Page 2817Pharmacopeial Forum: Volume No. 30(1) Page 92