Chloral Hydrate Capsules
»Chloral Hydrate Capsules contain not less than 95.0percent and not more than 110.0percent 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 Identificationtest under Chloral Hydrate.
Dissolution á711ñ—
Medium: water;500mL.
Apparatus 2: 50rpm.
Time: 15minutes.
Procedure— Place 1Capsule 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 15minutes.If 1or 2of the Capsules rupture in more than 15but not more than 30minutes,repeat the test on 12additional Capsules.Not more than 2of the total of 18Capsules tested rupture in more than 15but not more than 30minutes.
Uniformity of dosage units á905ñ: meet the requirements.
Assay— Place a counted number of Capsules,equivalent to about 2.5g of chloral hydrate,in a glass-stoppered,250-mLflask,add 25mLof 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 25mLof neutralized alcohol and 20.0mLof 1Nsodium hydroxide VS,mix,and allow the mixture to stand for 4minutes.Add phenolphthalein TS,and titrate the excess alkali with 1Nsulfuric acid VS.Each mLof 1Nsodium hydroxide is equivalent to 165.4mg of C2H3Cl3O2.
Auxiliary Information— Staff Liaison:Ravi Ravichandran,Ph.D.,Senior Scientist
Expert Committee:(PA3)Pharmaceutical Analysis 3
USP28–NF23Page 425
Phone Number:1-301-816-8330