Chloral Hydrate Oral Solution
(Monograph under this new title—to become official June 1,2005)
(Current monograph title is Chloral Hydrate Syrup)
»Chloral Hydrate Oral Solution contains not less than 95.0percent and not more than 110.0percent of the labeled amount of chloral hydrate (C2H3Cl3O2).
Packaging and storage— Preserve in tight,light-resistant containers.
Identification— It meets the requirements for the Identificationtest under Chloral Hydrate.
Assay— Transfer 25.0mLof Oral Solution to a 250-mLconical flask with the aid of several portions of water.Add 30.0mLof 1Nsodium hydroxide VS,and mix.After the mixture has stood for 2minutes,add 5drops of phenolphthalein TS,and immediately titrate the excess sodium hydroxide with 1Nsulfuric acid VS.Designate the volume of 1Nsodium hydroxide VSconsumed asA.Transfer 5.0mLof Oral Solution to a second 250-mLconical flask with the aid of several portions of water.Add 10drops of phenolphthalein TS,and titrate with 0.1Nsodium hydroxide VS.Designate the volume of 0.1Nsodium hydroxide VSconsumed as B.Calculate the weight,in mg,of chloral hydrate (C2H3Cl3O2)in the amount of Oral Solution taken by the first titration by the formula:
165.4(A-0.5B).
(Official June 1,2005)
Auxiliary Information— Staff Liaison:Ravi Ravichandran,Ph.D.,Senior Scientist
Expert Committee:(PA3)Pharmaceutical Analysis 3
USP28–NF23Page 426
Phone Number:1-301-816-8330