Procarbazine Hydrochloride
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This article is compiled based on the United States Pharmacopeia (USP) – 2025 Edition
Issued and maintained by the United States Pharmacopeial Convention (USP)
» 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.
USP Reference standards 〈11〉—
USP Procarbazine Hydrochloride RS
1 Identification—
Change to read:
A: ▲Spectroscopic Identification Tests 〈197〉, Infrared Spectroscopy: 197M▲ (CN 1-May-2020).
Change to read:
B: ▲Spectroscopic Identification Tests 〈197〉, Ultraviolet-Visible Spectroscopy: 197U▲ (CN 1-May-2020) —
[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%.
2 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.
