Packaging and storage— Preserve in single-dose or multiple-dose containers, preferably of Type I glass. The Injection may be packaged in 50-mL containers.

Labeling— The label indicates that the Injection is not to be used if it contains a precipitate.

USP Reference standards 11— USP Endotoxin RS. USP Pentobarbital RS.

Identification— The residue obtained in the Assay responds to Identification test A under Pentobarbital Sodium.

Bacterial endotoxins 85— It contains not more than 0.8 USP Endotoxin Unit per mg of pentobarbital sodium.

pH 791: between 9.0 and 10.5.

Residual solvents 467: meets the requirements.

Other requirements— It meets the requirements under Injections 1.

Assay— Pipet a volume of Injection, equivalent to about 500 mg of pentobarbital sodium, into a separator, and dilute with water to about 15 mL. To the solution add 2 mL of hydrochloric acid, shake, and completely extract the liberated pentobarbital with 25-mL portions of chloroform. Test for completeness of extraction by extracting with an additional 10-mL portion of chloroform and evaporating the solvent: not more than 0.5 mg of residue remains. Filter each extract through a pledget of chloroform-washed cotton, or other suitable filter, into a tared beaker, and finally wash the separator and the filter with several small portions of chloroform. Evaporate the combined filtrate and washings on a steam bath with the aid of a current of air, add 10 mL of ether, again evaporate, dry the residue at 105 for 2 hours, cool, and weigh. The weight of the residue, multiplied by 1.097, represents the weight of pentobarbital sodium (C11H17N2NaO3).

Expert Committee : (MDPP05) Monograph Development-Psychiatrics and Psychoactives

USP29–NF24 Page 1680

Phone Number : 1-301-816-8330