Chloral Hydrate Syrup
(Current title—not to change until June 1,2005)
Monograph title change—to become official June 1,2005
See Chloral Hydrate Oral Solution
»Chloral Hydrate Syrup contains not less than 95.0percent and not more than 110.0percent of the labeled amount of C2H3Cl3O2.
Packaging and storage— Preserve in tight,light-resistant containers.
Identification— It responds to the Identificationtest under Chloral Hydrate.
Assay— Transfer 25.0mLof Syrup 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 as A.Transfer 5.0mLof Syrup 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 C2H3Cl3O2in the amount of Syrup taken by the first titration by the formula:
165.4(A-0.5B).
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
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