Pentobarbital Sodium Injection
»Pentobarbital Sodium Injection is a sterile solution of Pentobarbital Sodium in a suitable solvent.Pentobarbital may be substituted for the equivalent amount of Pentobarbital Sodium,for adjustment of the pH.The Injection contains the equivalent of not less than 92.0percent and not more than 108.0percent of the labeled amount of C11H17N2NaO3.
Packaging and storage— Preserve in single-dose or multiple-dose containers,preferably of Type Iglass.The Injection may be packaged in 50-mLcontainers.
Labeling— The label indicates that the Injection is not to be used if it contains a precipitate.
Identification— The residue obtained in the Assayresponds to Identificationtest Aunder Pentobarbital Sodium.
Bacterial endotoxins á85ñ— It contains not more than 0.8USP Endotoxin Unit per mg of pentobarbital sodium.
pHá791ñ: between 9.0and 10.5.
Other requirements— It meets the requirements under Injections á1ñ.
Assay— Pipet a volume of Injection,equivalent to about 500mg of pentobarbital sodium,into a separator,and dilute with water to about 15mL.To the solution add 2mLof hydrochloric acid,shake,and completely extract the liberated pentobarbital with 25-mLportions of chloroform.Test for completeness of extraction by extracting with an additional 10-mLportion of chloroform and evaporating the solvent:not more than 0.5mg 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 10mLof ether,again evaporate,dry the residue at 105for 2hours,cool,and weigh.The weight of the residue,multiplied by 1.097,represents the weight of pentobarbital sodium (C11H17N2NaO3).
Auxiliary Information— Staff Liaison:Ravi Ravichandran,Ph.D.,Senior Scientist
Expert Committee:(PA3)Pharmaceutical Analysis 3
USP28–NF23Page 1511
Phone Number:1-301-816-8330