Chloral Hydrate Oral Solution

» Chloral Hydrate Oral Solution contains not less than 95.0 percent and not more than 110.0 percent of the labeled amount of chloral hydrate (C2H3Cl3O2).

Packaging and storage— Preserve in tight, light-resistant containers.

Identification— It meets the requirements for the Identification test under Chloral Hydrate.

Assay— Transfer 25.0 mL of Oral Solution to a 250-mL conical flask with the aid of several portions of water. Add 30.0 mL of 1 N sodium hydroxide VS, and mix. After the mixture has stood for 2 minutes, add 5 drops of phenolphthalein TS, and immediately titrate the excess sodium hydroxide with 1 N sulfuric acid VS. Designate the volume of 1 N sodium hydroxide VS consumed as A. Transfer 5.0 mL of Oral Solution to a second 250-mL conical flask with the aid of several portions of water. Add 10 drops of phenolphthalein TS, and titrate with 0.1 N sodium hydroxide VS. Designate the volume of 0.1 N sodium hydroxide VS consumed 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).

Auxiliary Information— Please check for your question in the FAQs before contacting USP.

Topic/Question	Contact	Expert Committee
Monograph	Ravi Ravichandran, Ph.D. Senior Scientist 1-301-816-8330	(MDPP05) Monograph Development-Psychiatrics and Psychoactives

USP32–NF27 Page 1883