Description

Verapamil Impurity I is a designated impurity standard used in the analytical profiling and quality control of the cardiovascular drug Verapamil. This compound is critical for pharmaceutical manufacturers and analytical laboratories to ensure product purity, safety, and regulatory compliance. It is primarily utilized in research and development, method validation, and stability studies for Verapamil hydrochloride and related formulations.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the identification and quantification of Verapamil Impurity I in active pharmaceutical ingredients (APIs) and finished drug products.
• Analytical Method Development & Validation: Essential for developing and validating HPLC, UPLC, or GC methods to monitor impurities during the drug manufacturing process.
• Quality Control & Assurance (QC/QA): Used in routine batch testing to ensure Verapamil drug substances and products meet pharmacopeial specifications (e.g., USP, EP, ICH guidelines).
• Stability Studies: Employed to track the formation of this specific degradation product under various stress conditions (e.g., heat, light, humidity) to establish shelf life.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., ANDA, NDA) by providing necessary impurity data for drug master files and safety assessments.
• Research & Development: Used in synthetic chemistry research to study the degradation pathways and metabolism of Verapamil.

Basic Information

Product Name	Verapamil Impurity I
CAS No.	2893-91-6
Molecular Formula	C27H38N2O4
Molecular Weight	454.60 g/mol
Synonyms	Verapamil Impurity A; Verapamil Related Compound A; 5-[(3,4-Dimethoxyphenethyl)methylamino]-2-(3,4-dimethoxyphenyl)-2-isopropylvaleronitrile; α-[3-[[2-(3,4-Dimethoxyphenyl)ethyl]methylamino]propyl]-3,4-dimethoxy-α-(1-methylethyl)benzenepropanenitrile; D 365; Iproveratril Impurity I
EINECS	220-791-6

Quality Control

Our Verapamil Impurity I is manufactured under strict quality control protocols to ensure high purity and batch-to-batch consistency suitable for analytical applications. Each batch is characterized and tested using advanced spectroscopic and chromatographic techniques. A comprehensive Certificate of Analysis (COA) is provided, detailing purity, identity confirmation (by IR, NMR), and impurity profile (by HPLC). Our quality system supports compliance with current Good Manufacturing Practices (cGMP) and relevant ICH guidelines.

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 product 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 powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual impurity ≤ 0.5%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

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