Temazepam Capsules
» Temazepam Capsules contain not less than 90.0 percent and not more than 110.0 percent of the labeled amount of temazepam (C16H13O2N2Cl).
Caution: Temazepam is a potent sedative: its powder should not be inhaled.
Packaging and storage— Preserve in well-closed, light-resistant containers.
A: The retention time of the major peak in the chromatogram of the Assay preparation corresponds to that of the Standard preparation, both relative to the internal standard, as obtained in the Assay.
B: Transfer a portion of the Capsule contents, equivalent to about 50 mg of temazepam, to a 25-mL volumetric flask, add 10 mL of methanol, shake by mechanical means, and allow to settle. Use the supernatant layer as the test solution. Separately apply 20 µL of the test solution and 20 µL of a Standard solution of USP Temazepam RS in methanol containing 5.0 mg per mL to a thin-layer chromatographic plate (see Chromatography 621) coated with a 0.25-mm layer of chromatographic silica gel mixture. Place the plate in a chromatographic chamber, and develop the chromatogram in a solvent system consisting of a mixture of toluene, dioxane, methanol, and ammonium hydroxide (65:30:5:1) until the solvent front has moved about three-fourths of the length of the plate. Remove the plate from the developing chamber, mark the solvent front, air-dry, and examine the plate under short-wavelength UV light: the RF value of the principal spot obtained from the test solution corresponds to that obtained from the Standard solution.
Dissolution 711
Sodium acetate buffer— Dissolve 2 g of sodium hydroxide in 450 mL of water in a 1-liter volumetric flask. Adjust with acetic acid to a pH of 4.0, dilute with water to volume, mix, and deaerate.
Medium: Sodium acetate buffer with 0.05% polysorbate 80; 900 mL.
Apparatus 2: 75 rpm.
Time: 30 minutes.
Determine the amount of C16H13O2N2Cl dissolved from UV absorbances, at the wavelength of maximum absorbance at about 310 nm of filtered portions of the solution under test, suitably diluted with Sodium acetate buffer, in comparison with a Standard solution having a known concentration of USP Temazepam RS in the same medium.
Tolerances— Not less than 80% (Q) of the labeled amount of C16H13O2N2Cl is dissolved in 30 minutes.
Uniformity of dosage units 905: meet the requirements.
Buffer solution, Mobile phase, Internal standard solution, Standard preparation, Chromatographic system, and Procedure Proceed as directed in the Assay under Temazepam.
Assay preparation— Weigh the contents of not less than 20 Capsules, and calculate the average weight per Capsule. Mix the combined contents, and transfer an accurately weighed portion of the Capsule contents, equivalent to about 40 mg of temazepam, to a 200-mL volumetric flask, add 150 mL of Internal standard solution, and shake the mixture by mechanical means for 30 minutes. Dilute with Internal standard solution to volume, and mix. Allow the contents of the flask to settle, and filter, discarding the first 5 mL of the filtrate.
Auxiliary Information— Please check for your question in the FAQs before contacting USP.
Topic/Question Contact Expert Committee
Monograph Ravi Ravichandran, Ph.D.
Senior Scientist
(MDPP05) Monograph Development-Psychiatrics and Psychoactives
Reference Standards Lili Wang, Technical Services Scientist
711 Margareth R.C. Marques, Ph.D.
Senior Scientist
(BPC05) Biopharmaceutics05
USP32–NF27 Page 3675
Chromatographic Column—
Chromatographic columns text is not derived from, and not part of, USP 32 or NF 27.