Description

Verapamil Impurity N is a high-purity chemical reference standard used for the analytical profiling and quality control of the cardiovascular drug Verapamil. This compound is critical for pharmaceutical manufacturers and research laboratories to ensure product safety, efficacy, and regulatory compliance by accurately identifying and quantifying process-related impurities. It is an essential material for method development, validation, and stability studies within the pharmaceutical industry.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of Verapamil Impurity N in active pharmaceutical ingredient (API) and finished drug product analysis.
• Analytical Method Development & Validation: Used to develop, optimize, and validate chromatographic methods, such as HPLC and UPLC, for impurity profiling.
• Quality Control & Assurance (QC/QA): Serves as a system suitability standard and for routine batch testing in pharmaceutical QC laboratories to monitor impurity levels against ICH guidelines.
• Stability Studies: Employed in forced degradation and long-term stability testing of Verapamil to track the formation of this specific impurity over time and under various stress conditions.
• Regulatory Submissions: Provides essential data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs) to meet FDA, EMA, and other global health authority requirements.
• Research & Development: Used in pharmaceutical R&D to study the synthesis pathway, degradation mechanisms, and metabolic pathways of Verapamil.

Basic Information

Product Name	Verapamil Impurity N
CAS No.	2086274-75-9
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Verapamil Related Compound N; Verapamil EP Impurity N; Verapamil USP Impurity N; 5-[(3,4-Dimethoxyphenethyl)methylamino]-2-(3,4-dimethoxyphenyl)-2-isopropylvaleronitrile Impurity; (RS)-Verapamil Impurity N; Norverapamil Impurity; Desmethylverapamil Impurity
EINECS	Contact for details

Quality Control

Every batch of Verapamil Impurity N is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced analytical techniques to ensure compliance with pharmacopeial standards (e.g., USP, EP) and ICH Q3A/B guidelines. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results for purity, related substances, residual solvents, and other critical quality attributes.

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 should be handled in a dry environment to prevent degradation. For long-term storage, consider desiccated conditions.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
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.