Tetracycline Hydrochloride and Nystatin Capsules
» Tetracycline Hydrochloride and Nystatin Capsules contain not less than 90.0 percent and not more than 125.0 percent of the labeled amount of tetracycline hydrochloride (C22H24N2O8·HCl), and not less than 90.0 percent and not more than 135.0 percent of the labeled amount of USP Nystatin Units.
Packaging and storage— Preserve in tight, light-resistant containers.
Identification— Shake a suitable quantity of Capsule contents with methanol to obtain a solution containing about 1 mg of tetracycline hydrochloride per mL, and filter. Using the filtrate as the Test Solution, proceed as directed under Identification—Tetracyclines 193.
Dissolution 711
Medium: water; 900 mL.
Apparatus 2: 75 rpm.
Time: 60 minutes.
Procedure— Determine the amount of tetracycline hydrochloride (C22H24N2O8·HCl) dissolved from UV absorbances at the wavelength of maximum absorbance at about 276 nm of filtered portions of the solution under test, suitably diluted with Dissolution Medium, if necessary, in comparison with a Standard solution having a known concentration of USP Tetracycline Hydrochloride RS in the same Medium.
Tolerances— Not less than 70% (Q) of the labeled amount of C22H24N2O8·HCl is dissolved in 60 minutes.
Loss on drying 731 Dry about 100 mg of Capsule contents, accurately weighed, in a capillary-stoppered bottle in vacuum at a pressure not exceeding 5 mm of mercury at 60 for 3 hours: it loses not more than 4.0% of its weight.
Limit of 4-epianhydrotetracycline 226 To a quantity of Capsule contents, equivalent to about 250 mg of tetracycline hydrochloride, add 10 mL of 0.1 N hydrochloric acid, and adjust with 6 N ammonium hydroxide to a pH of 7.8. Transfer this solution with the aid of EDTA Buffer to a 50-mL volumetric flask, dilute with EDTA Buffer to volume, and mix. Use this solution, without delay, as the Test Solution: not more than 3.0% is found.
Assay for tetracycline hydrochloride— Proceed with Capsules as directed in the Assay under Tetracycline Hydrochloride Capsules.
Assay for nystatin— Proceed as directed for Nystatin under Antibiotics—Microbial Assays 81, blending not less than 5 Capsules for 3 to 5 minutes in a high-speed blender with a sufficient, accurately measured, volume of dimethylformamide to obtain a solution of convenient concentration. Dilute an accurately measured portion of this solution quantitatively with dimethylformamide to obtain a stock solution containing about 400 USP Nystatin Units per mL. Dilute this stock solution quantitatively with Buffer No. 6 to obtain a Test Dilution having a concentration of nystatin assumed to be equal to the median dose level of the Standard.
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
711 Margareth R.C. Marques, Ph.D.
Senior Scientist
(BPC05) Biopharmaceutics05
USP32–NF27 Page 3702