Description

Verapamil Impurity CAS NO 1551304-28-9 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for pharmaceutical quality control, enabling the accurate identification, quantification, and monitoring of impurities in Verapamil hydrochloride drug substances and finished products. It is an essential material for analytical chemists and quality assurance professionals in the pharmaceutical industry, particularly those involved in method development, validation, and regulatory compliance testing to ensure drug safety and efficacy.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the qualitative and quantitative analysis of Verapamil and related substances.
• Analytical Method Development & Validation: Used to develop, optimize, and validate HPLC, UPLC, or GC methods for impurity profiling in compliance with ICH Q3A(R2) and Q3B(R2) guidelines.
• Quality Control & Assurance: Serves as a system suitability standard and for routine batch testing in pharmaceutical QC laboratories to ensure impurity levels are within specified limits.
• Regulatory Compliance & Submission: Essential for generating data for regulatory filings (e.g., ANDA, NDA) with agencies like the US FDA, EMA, and other global health authorities.
• Stability Studies: Employed in forced degradation and long-term stability studies of Verapamil to identify and track potential degradation products.
• Research & Development: Used in academic and industrial R&D settings for studying the metabolism, pharmacokinetics, and degradation pathways of Verapamil.

Basic Information

Product Name	Verapamil Impurity
CAS No.	1551304-28-9
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Verapamil Related Compound; Verapamil Impurity Standard; Verapamil EP Impurity; Verapamil USP Impurity; 5-[(3,4-Dimethoxyphenethyl)methylamino]-2-(3,4-dimethoxyphenyl)-2-isopropylvaleronitrile Impurity; (±)-Verapamil Impurity; α-Isopropyl-α-[(N-methyl-N-homoveratryl)-γ-aminopropyl]-3,4-dimethoxybenzenacetonitrile Impurity
EINECS	Contact for details

Quality Control

Every batch of Verapamil Impurity CAS NO 1551304-28-9 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity confirmation, purity assay, and impurity profiling using advanced analytical techniques such as HPLC, GC-MS, and NMR to ensure compliance with pharmacopeial standards (USP, EP, BP). A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results, and is available upon request.

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 desiccated environment to maintain stability and purity. For long-term storage, consider storing under an inert atmosphere.

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)	Single unspecified impurity ≤ 1.0% Total impurities ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 0.5%

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