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

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

Identification— Mix a volume of Injection,equivalent to about 60mg of hydralazine hydrochloride,with an amount of 1Nhydrochloric acid sufficient to prepare 25mLof solution.Place 20mLof this solution in a separator,wash with 10mLof methylene chloride,and discard the methylene chloride washing.Mix the aqueous solution in the separator with 2mLof sodium nitrite solution (14in 1000),add 10mLof methylene chloride,shake by mechanical means for 5minutes,and allow the layers to separate.Pass the methylene chloride layer through a filter of anhydrous sodium sulfate that previously has been washed with methylene chloride,and collect the solution in a 50-mLbeaker.Evaporate with the aid of gentle heat and a stream of dry nitrogen to dryness:the IRabsorption spectrum of a potassium bromide dispersion of the residue so obtained exhibits maxima only at the same wavelengths as that of USP Hydralazine Hydrochloride RSsimilarly treated and prepared.

Bacterial endotoxins á85ñ— It contains not more than 1.45USP Endotoxin Units per mg of hydralazine hydrochloride.

pHá791ñ: between 3.4and 4.4.

Particulate matter á788ñ: meets the requirements for small-volume injections.

Other requirements— It meets the requirements under Injections á1ñ.

Assay— Transfer to a 250-mLiodine flask an accurately measured volume of Injection,equivalent to about 100mg of hydralazine hydrochloride.Add 20mLof hydrochloric acid,cool to room temperature,add 5mLof chloroform,and titrate with 0.02Mpotassium iodate VSuntil the purple color of iodine disappears from the chloroform,adding the last portion of the potassium iodate solution dropwise and agitating the mixture vigorously and continuously.Each mLof 0.02Mpotassium iodate is equivalent to 3.933mg of hydralazine hydrochloride (C8H8N4·HCl).

Expert Committee:(PA5)Pharmaceutical Analysis 5

USP28–NF23Page 952

Phone Number:1-301-816-8305