Description

Procarbazine Hydrochloride is a synthetic antineoplastic agent belonging to the class of alkylating hydrazine derivatives. It is a critical active pharmaceutical ingredient (API) primarily used in the formulation of combination chemotherapy regimens. This compound is essential for pharmaceutical manufacturers and research institutions developing treatments for specific hematological cancers. Its mechanism involves metabolic activation to form reactive species that inhibit DNA, RNA, and protein synthesis.

Application

• Pharmaceutical API: Primary use as the active ingredient in the manufacture of antineoplastic drugs for chemotherapy.
• Oncological Formulations: Key component in the MOPP regimen (Mechlorethamine, Oncovin® (vincristine), Procarbazine, Prednisone) for treating Hodgkin's lymphoma.
• Biomedical Research: Used as a biochemical tool in cancer research to study mechanisms of alkylation, DNA damage, and apoptosis in cell lines and animal models.
• Reference Standard: Serves as a high-purity analytical standard for quality control testing in pharmaceutical laboratories.
• Clinical Trial Material: Supplied as a raw material for the production of investigational new drugs (INDs) in clinical trials.

Basic Information

Product Name	Procarbazine Hydrochloride
CAS No.	366-70-1
Molecular Formula	C12H19N3O • HCl
Molecular Weight	257.76 g/mol
Synonyms	N-Isopropyl-α-(2-methylhydrazino)-p-toluamide Hydrochloride; Ibenzmethyzin Hydrochloride; Natulan Hydrochloride; Matulane (brand name); Ro 4-6467/1; NSC-77213; p-(N-Methylhydrazinomethyl)-N-isopropylbenzamide Hydrochloride
EINECS	206-685-5

Quality Control

Our Procarbazine Hydrochloride is manufactured and tested under a strict quality management system. Each batch is analyzed to ensure it meets high-purity standards suitable for pharmaceutical applications. A comprehensive Certificate of Analysis (COA) is provided, detailing results for identity, purity, assay, and specified impurities. We support compliance with cGMP, ICH Q7 guidelines, and relevant pharmacopeial standards (USP/EP) as required.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and must be kept in a dry environment to prevent degradation. For long-term storage, consider using desiccants.

Specification

Item	Specification
Appearance	White to off-white crystalline powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%
Heavy Metals	≤ 20 ppm
Related Substances (HPLC)	Individual impurity ≤ 0.5%; Total impurities ≤ 1.5%
Microbial Enumeration	Meets USP <61> requirements

Note: Specifications can be tailored. Please contact us for the detailed technical data sheet of a specific grade.