Description

(±)-Disopyramide CAS NO 74427-45-5 is a chiral pharmaceutical intermediate and active pharmaceutical ingredient (API) belonging to the class IA antiarrhythmic agents. It is a critical compound for the development and manufacturing of cardiac medications, primarily used to treat ventricular and supraventricular arrhythmias. This high-purity chemical is essential for pharmaceutical R&D laboratories, API manufacturers, and contract development and manufacturing organizations (CDMOs) serving the global cardiovascular drug market.

Application

• Pharmaceutical Active Ingredient (API): Primary use as the active component in antiarrhythmic drug formulations.
• Reference Standard: Serves as a certified reference material (CRM) for quality control and analytical method development in pharmacopeial testing (USP, EP).
• Pharmacological Research: Used in preclinical and clinical studies to investigate cardiac electrophysiology and antiarrhythmic mechanisms of action.
• Process Chemistry & Intermediate: A key chiral intermediate in the synthetic pathway for producing enantiomerically pure Disopyramide phosphate.
• Generic Drug Manufacturing: Critical for companies producing generic versions of antiarrhythmic medications containing Disopyramide.
• Impurity Profiling: Utilized to identify and quantify related substances and degradation products in finished drug products.

Basic Information

Product Name	(±)-Disopyramide
CAS No.	74427-45-5
Molecular Formula	C21H29N3O
Molecular Weight	339.48 g/mol
Synonyms	Disopyramide (racemic); α-(2-(Bis(1-methylethyl)amino)ethyl)-α-phenyl-2-pyridineacetamide; 4-(Diisopropylamino)-2-phenyl-2-(2-pyridyl)butyramide; SC-7031; Rythmodan (racemate); Norpace (racemate); Dicorantil (racemate); (±)-4-[Bis(1-methylethyl)amino]-2-phenyl-2-(2-pyridinyl)butanamide
EINECS	Contact for details

Quality Control

Our (±)-Disopyramide is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing to ensure it meets stringent specifications for identity, purity, and impurity profiles, suitable for pharmaceutical applications. A Certificate of Analysis (COA) detailing results for assay, related substances, residual solvents, and other critical parameters is provided with every shipment. We support compliance with cGMP, ICH Q7, and major pharmacopeial standards (USP/EP) as required.

Storage

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

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)	≤ 0.5%
Residue on Ignition	≤ 0.1%
Related Substances (HPLC)	Individual impurity: ≤ 0.5% Total impurities: ≤ 1.5%
Heavy Metals	≤ 20 ppm
Residual Solvents (GC)	Complies with ICH Q3C Class 2 & 3 limits
Optical Rotation	-0.10° to +0.10° (c=1 in methanol)

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