Hydralazine Hydrochloride Injection
» Hydralazine Hydrochloride Injection is a sterile solution of Hydralazine Hydrochloride in Water for Injection. It contains not less than 95.0 percent and not more than 105.0 percent of the labeled amount of hydralazine hydrochloride(C8H8N4·HCl).
Packaging and storage— Preserve in single-dose or in multiple-dose containers, preferably of Type I glass.
Identification— Mix a volume of Injection, equivalent to about 60 mg of hydralazine hydrochloride, with an amount of 1 N hydrochloric acid sufficient to prepare 25 mL of solution. Place 20 mL of this solution in a separator, wash with 10 mL of methylene chloride, and discard the methylene chloride washing. Mix the aqueous solution in the separator with 2 mL of sodium nitrite solution (14 in 1000), add 10 mL of methylene chloride, shake by mechanical means for 5 minutes, 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-mL beaker. Evaporate with the aid of gentle heat and a stream of dry nitrogen to dryness: the IR absorption spectrum of a potassium bromide dispersion of the residue so obtained exhibits maxima only at the same wavelengths as that of USP Hydralazine Hydrochloride RS similarly treated and prepared.
Bacterial endotoxins 85— It contains not more than 1.45 USP Endotoxin Units per mg of hydralazine hydrochloride.
pH 791: between 3.4 and 4.4.
Particulate matter 788: meets the requirements for small-volume injections.
Other requirements— It meets the requirements under Injections 1.
Assay— Transfer to a 250-mL iodine flask an accurately measured volume of Injection, equivalent to about 100 mg of hydralazine hydrochloride. Add 20 mL of hydrochloric acid, cool to room temperature, add 5 mL of chloroform, and titrate with 0.02 M potassium iodate VS until 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 mL of 0.02 M potassium iodate is equivalent to 3.933 mg of hydralazine hydrochloride (C8H8N4·HCl).
Auxiliary Information— Please check for your question in the FAQs before contacting USP.
Topic/Question Contact Expert Committee
Monograph Sujatha Ramakrishna, Ph.D.
Scientist
1-301-816-8349		 (MDCV05) Monograph Development-Cardiovascular
Reference Standards Lili Wang, Technical Services Scientist
1-301-816-8129
RSTech@usp.org
85 Radhakrishna S Tirumalai, Ph.D.
Senior Scientist
1-301-816-8339		 (MSA05) Microbiology and Sterility Assurance
USP32–NF27 Page 2564