Procarbazine Hydrochloride
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Benzamide,N-(1-methylethyl)-4-[(2-methylhydrazino)methyl]-,monohydrochloride.
N-Isopropyl-a-(2-methylhydrazino)-p-toluamide monohydrochloride [366-70-1].
»Procarbazine Hydrochloride contains not less than 98.5percent and not more than 100.5percent 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—
A:
Infrared Absorption á197Mñ.
B:
Ultraviolet Absorption á197Uñ—[NOTE—Use low-actinic glassware throughout this test.]
Solution:
10µg per mL.
Medium:
0.1Nhydrochloric acid.
Absorptivities at 232nm do not differ by more than 3.0%.
Residue on ignition á281ñ:
not more than 0.1%.
Heavy metals,Method IIá231ñ:
0.002%.
Organic volatile impurities,Method Iá467ñ:
meets the requirements.
Assay—
Dissolve about 0.75g of Procarbazine Hydrochloride,accurately weighed,in 100mLof water.Titrate with 0.1Nsodium hydroxide VS,determining the endpoint potentiometrically,using a calomel-glass electrode system.Each mLof 0.1Nsodium hydroxide is equivalent to 25.78mg of C12H19N3O·HCl.
Auxiliary Information—
Staff Liaison:Lawrence Evans,III,Ph.D.,Scientist
Expert Committee:(PA6)Pharmaceutical Analysis 6
USP28–NF23Page 1630
Phone Number:1-301-816-8389