Chloral Hydrate Capsules
» Chloral Hydrate Capsules contain not less than 95.0 percent and not more than 110.0 percent of the labeled amount of C2H3Cl3O2.
Packaging and storage— Preserve in tight containers, preferably at controlled room temperature.
Identification— The contents of the Capsules respond to the Identification test under Chloral Hydrate.
Dissolution 711
Medium: water; 500 mL.
Apparatus 2: 50 rpm.
Time: 15 minutes.
Procedure— Place 1 Capsule in each vessel, and allow the Capsule to sink to the bottom of the vessel before starting rotation of the blade. Observe the Capsules, and record the time taken for each capsule shell to rupture.
Tolerances— The requirements are met if all of the Capsules tested rupture in not more than 15 minutes. If 1 or 2 of the Capsules rupture in more than 15 but not more than 30 minutes, repeat the test on 12 additional Capsules. Not more than 2 of the total of 18 Capsules tested rupture in more than 15 but not more than 30 minutes.
Uniformity of dosage units 905: meet the requirements.
Assay— Place a counted number of Capsules, equivalent to about 2.5 g of chloral hydrate, in a glass-stoppered, 250-mL flask, add 25 mL of water, insert the stopper in the flask, and heat on a steam bath with frequent swirling until the Capsules are dissolved. Cool to room temperature, add 25 mL of neutralized alcohol and 20.0 mL of 1 N sodium hydroxide VS, mix, and allow the mixture to stand for 4 minutes. Add phenolphthalein TS, and titrate the excess alkali with 1 N sulfuric acid VS. Each mL of 1 N sodium hydroxide is equivalent to 165.4 mg of C2H3Cl3O2.
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Monograph Ravi Ravichandran, Ph.D.
Senior Scientist
(MDPP05) Monograph Development-Psychiatrics and Psychoactives
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USP32–NF27 Page 1883