Packaging and storage— Preserve in single-dose or in multiple-dose containers,preferably of Type Iglass,protected from light.

USP Reference standards á11ñ— USP Promazine Hydrochloride RS.USP Endotoxin RS.

Identification—

Bacterial endotoxins á85ñ— It contains not more than 1.8USP Endotoxin Units per mg of promazine hydrochloride.

pHá791ñ: between 4.0and 5.5.

Other requirements— It meets the requirements under Injections á1ñ.

Assay— [NOTE—Use low-actinic glassware.]Transfer a volume of Injection,equivalent to about 50mg of promazine hydrochloride,to a 100-mLvolumetric flask,dilute with 0.1Nhydrochloric acid to volume,and mix.Transfer 10.0mLof the solution to a 250-mLseparator,add 20mLof water,render alkaline with ammonium hydroxide,and extract with four 25-mLportions of ether.Extract the combined ether extracts with five 15-mLportions of 0.1Nhydrochloric acid,collecting the aqueous extracts in a 100-mLvolumetric flask.Aerate to remove residual ether,dilute with 0.1Nhydrochloric acid to volume,and mix.Without delay,concomitantly determine the absorbances of this solution and of a Standard solution of USP Promazine Hydrochloride RSin the same medium having a known concentration of about 50µg per mLin 1-cm cells at the wavelength of maximum absorbance at about 301nm,with a suitable spectrophotometer,using 0.1Nhydrochloric acid as the blank.Calculate the quantity,in mg,of C17H20N2S·HCl in each mLof the Injection taken by the formula: in which Cis the concentration,in µg per mL,of USP Promazine Hydrochloride RSin the Standard solution,Vis the volume,in mL,of Injection taken,and AUand ASare the absorbances of the solution from the Injection and the Standard solution,respectively.

Expert Committee:(PA1)Pharmaceutical Analysis 1

USP28–NF23Page 1639

Phone Number:1-301-816-8379