U.S. PHARMACOPEIA

Search USP29  
Procarbazine Hydrochloride
Click to View Image
C12H19N3O·HCl 257.76

Benzamide, N-(1-methylethyl)-4-[(2-methylhydrazino)methyl]-, monohydrochloride.
N-Isopropyl--(2-methylhydrazino)-p-toluamide monohydrochloride [366-70-1].
» Procarbazine Hydrochloride contains not less than 98.5 percent and not more than 100.5 percent of C12H19N3O·HCl.
Caution—Handle Procarbazine Hydrochloride with exceptional care, since it is a highly potent agent.
Packaging and storage— Preserve in tight, light-resistant containers.
Identification—
B: Ultraviolet Absorption 197U—[NOTE—Use low-actinic glassware throughout this test.]
Solution: 10 µg per mL.
Medium: 0.1 N hydrochloric acid.
Absorptivities at 232 nm do not differ by more than 3.0%.
Residue on ignition 281: not more than 0.1%.
Heavy metals, Method II 231: 0.002%.
Organic volatile impurities, Method I 467: meets the requirements.
Residual solvents 467: meets the requirements.
(Official January 1, 2007)
Assay— Dissolve about 0.75 g of Procarbazine Hydrochloride, accurately weighed, in 100 mL of water. Titrate with 0.1 N sodium hydroxide VS, determining the endpoint potentiometrically, using a calomel-glass electrode system. Each mL of 0.1 N sodium hydroxide is equivalent to 25.78 mg of C12H19N3O·HCl.
Auxiliary Information— Staff Liaison : Feiwen Mao, M.S., Senior Scientific Associate
Expert Committee : (MDOOD05) Monograph Development-Ophthalmics Oncologics and Dermatologicals
USP29–NF24 Page 1812
Phone Number : 1-301-816-8320