Description

Verapamil Impurity M is a designated impurity of the calcium channel blocker Verapamil, used in pharmaceutical research and development. This compound is critical for analytical method development, stability studies, and ensuring the quality and safety of the active pharmaceutical ingredient (API). It is primarily required by pharmaceutical manufacturers, contract research organizations (CROs), and quality control laboratories for regulatory compliance and impurity profiling.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material (CRM) for the identification and quantification of Verapamil Impurity M in drug substances and products.
• Analytical Method Development & Validation: Used to develop, optimize, and validate HPLC, UPLC, or LC-MS methods for impurity detection and separation.
• Stability Indicating Studies: Employed in forced degradation studies to understand the degradation pathways of Verapamil and to establish stability-indicating methods.
• Quality Control & Batch Release: Essential for routine quality control testing to monitor impurity levels and ensure batches meet pharmacopeial specifications (e.g., USP, EP, ICH Q3A/B).
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., FDA, EMA) to establish impurity thresholds and justify specifications.
• Research on Degradation Pathways: Used in research to elucidate the formation mechanism and chemical behavior of this specific impurity.

Basic Information

Product Name	Verapamil Impurity M
CAS No.	141991-89-1
Molecular Formula	C27H38N2O4
Molecular Weight	454.61 g/mol
Synonyms	5-[(3,4-Dimethoxyphenethyl)methylamino]-2-(3,4-dimethoxyphenyl)-2-isopropylvaleronitrile; Verapamil N-Oxide; Norverapamil N-Oxide; Verapamil Impurity 7; Verapamil Related Compound M; (±)-Verapamil N-Oxide; 2-(3,4-Dimethoxyphenyl)-5-{[2-(3,4-dimethoxyphenyl)ethyl](methyl)amino}-2-(1-methylethyl)pentanenitrile 1-Oxide
EINECS	Contact for details

Quality Control

Every batch of Verapamil Impurity M is manufactured and analyzed under strict quality management systems. Our products undergo rigorous quality testing to ensure compliance with industry standards, including identity confirmation, purity assessment by HPLC, and control of related substances. Certificates of Analysis (COA) containing detailed analytical results are available upon request.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. For long-term storage, consider storing under inert atmosphere to prevent potential oxidation.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual unknown impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 1.0%

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