C2H3Cl3O2 165.40

1,1-Ethanediol,2,2,2-trichloro-.
Chloral hydrate [302-17-0].

Packaging and storage— Preserve in tight containers.

Identification— Transfer to a 125-mLconical flask a portion of a solution in water equivalent to about 1mg of chloral hydrate,and add water to bring the volume to about 10mL.Add 10mLof 1-ethylquinaldinium iodide solution (15in 1000),which has been filtered through a 0.45-µm filter.Add 60mLof isopropyl alcohol,5mLof an aqueous 0.1Mmonoethanolamine solution,and 15mLof water.Mix,and heat in a water bath at 60for 15minutes:a blue color develops.

Acidity— A1in 20solution in alcohol does not at once redden moistened blue litmus paper.

Residue on ignition á281ñ: not more than 0.1%.

Chloride á221ñ— To a 1in 10solution in alcohol add a few drops of silver nitrate TS:any opalescence produced does not exceed that of a control containing 0.10mLof 0.020Nhydrochloric acid (0.007%).

Readily carbonizable substances á271ñ— Shake 500mg,at intervals of 5minutes during 1hour,with 5mLof sulfuric acid TSin a glass-stoppered cylinder that previously has been rinsed with sulfuric acid TS,and transfer the mixture to a comparison vessel:the mixture has no more color than Matching Fluid P.

Organic volatile impurities,Method Iá467ñ: meets the requirements.

Assay— Dissolve about 4g of Chloral Hydrate,accurately weighed,in 10mLof water,add 30.0mLof 1Nsodium hydroxide VS,and allow the mixture to stand for 2minutes.Add a few drops of phenolphthalein TS,and titrate the residual alkali at once with 1Nsulfuric acid VS.Each mLof 1Nsodium hydroxide corresponds to 165.4mg of C2H3Cl3O2.

Expert Committee:(PA3)Pharmaceutical Analysis 3

USP28–NF23Page 425

Phone Number:1-301-816-8330