U.S. PHARMACOPEIA

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Tetracycline Oral Suspension
» Tetracycline Oral Suspension is Tetracycline with or without one or more suitable buffers, preservatives, stabilizers, and suspending agents. It contains the equivalent of not less than 90.0 percent and not more than 125.0 percent of the labeled amount of tetracycline hydrochloride (C22H24N2O8·HCl).
Packaging and storage— Preserve in tight, light-resistant containers.
Identification— The chromatogram of the Assay preparation obtained as directed in the Assay exhibits a major peak for tetracycline, the retention time of which corresponds to that exhibited in the chromatogram 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 3.5 and 6.0.
Limit of 4-epianhydrotetracycline— Using the Diluting solvent, Chromatographic system, and Procedure set forth in the Assay, chromatograph a Standard solution prepared by dissolving an accurately weighed quantity of USP 4-Epianhydrotetracycline Hydrochloride RS in Diluting solvent to obtain a solution having a known concentration of about 10 µg per mL. Using the chromatogram so obtained and the chromatogram of the Assay preparation obtained as directed in the Assay, calculate the percentage of 4-epianhydrotetracycline in the Oral Suspension taken by the formula:
(25CE / T)(rU / rS),
in which CE is the concentration, in µg per mL, of USP 4-Epianhydrotetracycline Hydrochloride RS in the Standard solution, T is the quantity, in mg, of tetracycline hydrochloride equivalent in the portion of Oral Suspension taken, based on the labeled quantity, and rU and rS are the 4-epianhydrotetracycline peak responses obtained from the Assay preparation and the Standard solution, respectively: not more than 5.0% is found.
Residual solvents 467: meets the requirements.
(Official January 1, 2007)
Assay—
Diluting solvent, Mobile phase, Standard preparation, Resolution solution, and Chromatographic system— Prepare as directed in the Assay under Tetracycline Hydrochloride.
Assay preparation— Transfer an accurately measured volume of Oral Suspension, equivalent to about 125 mg of tetracycline hydrochloride, to a 250-mL volumetric flask, add 200 mL of Diluting solvent, and shake. Add Diluting solvent to volume, mix, and filter.
Procedure— Proceed as directed in the Assay under Tetracycline Hydrochloride. Calculate the quantity, in mg per mL, of C22H24N2O8·HCl equivalent in the Oral Suspension taken by the formula:
(CP / 4V)(rU / rS),
in which V is the volume, in mL, of Oral Suspension taken, and the other terms are as defined therein.
Auxiliary Information— Staff Liaison : Brian D. Gilbert, Ph.D., Scientist
Expert Committee : (MDANT05) Monograph Development-Antibiotics
USP29–NF24 Page 2097
Phone Number : 1-301-816-8223