Tetracycline Hydrochloride Ophthalmic Suspension
» Tetracycline Hydrochloride Ophthalmic Suspension is a sterile suspension of sterile Tetracycline Hydrochloride in a suitable oil. It contains not less than 90.0 percent and not more than 125.0 percent of the labeled amount of C22H24N2O8·HCl.
Packaging and storage— Preserve in tight, light-resistant containers of glass or plastic, containing not more than 15 mL. The containers or individual cartons are sealed and tamper-proof so that sterility is assured at time of first use.
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.
Sterility 71: meets the requirements.
Water, Method I 921: not more than 0.5%, 20 mL of a mixture of toluene and methanol (7:3) being used in place of methanol in the titration vessel.
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 Ophthalmic Suspension, equivalent to about 50 mg of tetracycline hydrochloride, with the aid of 30 mL of cyclohexane to a 125-mL separator, add 30 mL of Diluting solvent, insert the stopper, and shake. Allow to separate, and collect the lower layer in a 100-mL volumetric flask. Repeat the extraction with two additional 30-mL portions of Diluting solvent, combining the extracts in the 100-mL volumetric flask. Add Diluting solvent to volume, mix, and filter.
Procedure— Proceed as directed for Procedure in the Assay under Tetracycline Hydrochloride. Calculate the quantity, in mg per mL, of C22H24N2O8·HCl equivalent in the Ophthalmic Suspension taken by the formula:
(CP / 10V)(rU / rS)
in which V is the volume, in mL, of Ophthalmic Suspension taken, and the other terms are as defined therein.
Auxiliary Information— Please check for your question in the FAQs before contacting USP.
Topic/Question Contact Expert Committee
Monograph Ahalya Wise, M.S.
(MDANT05) Monograph Development-Antibiotics
Reference Standards Lili Wang, Technical Services Scientist
71 Radhakrishna S Tirumalai, Ph.D.
Senior Scientist
(MSA05) Microbiology and Sterility Assurance
USP32–NF27 Page 3699
Chromatographic Column—
Chromatographic columns text is not derived from, and not part of, USP 32 or NF 27.