Description

VERAPAMIL RELATED COMPOUND B (50 MG) (AL-PHA-[2-[[2-(3,4-DIMETHOXYPHENYL)-ETHYL]METHYLA-MINO]ETHYL]-3,4-DIMETHOXY-α-(1-METHY-LETHYL)-BENZENEACETONITRILE MONOHYDROCHLORIDE) is a high-purity chemical reference standard essential for analytical and quality control processes in the pharmaceutical industry. This compound is critical for ensuring the purity, safety, and efficacy of the calcium channel blocker drug Verapamil by serving as a known impurity marker. It is primarily needed by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and compliance testing. Supplied in a convenient 50 mg format, it supports precise and reliable impurity profiling.

Application

• Pharmaceutical Impurity Profiling and Identification as a certified reference material for Verapamil HCl.
• Analytical Method Development and Validation for HPLC, UPLC, and LC-MS techniques in QC labs.
• Stability Testing and Forced Degradation Studies to monitor impurity formation in drug substances and products.
• Pharmacopoeial Compliance Testing to meet USP, EP, and ICH guidelines for impurity limits.
• Calibration and System Suitability for chromatographic systems in regulatory filings.
• Research and Development of generic formulations and synthesis pathway optimization.

Basic Information

Product Name	VERAPAMIL RELATED COMPOUND B (50 MG) (AL-PHA-[2-[[2-(3,4-DIMETHOXYPHENYL)-ETHYL]METHYLA-MINO]ETHYL]-3,4-DIMETHOXY-α-(1-METHY-LETHYL)-BENZENEACETONITRILE MONOHYDROCHLORIDE)
CAS No.	1794-55-4
Molecular Formula	C27H39N2O4•ClH
Molecular Weight	491.07 g/mol
Synonyms	Verapamil Impurity B; Verapamil Related Substance B; D-617; α-[2-[[2-(3,4-Dimethoxyphenyl)ethyl]methylamino]ethyl]-3,4-dimethoxy-α-(1-methylethyl)benzeneacetonitrile Monohydrochloride; (R*,S*)-(±)-α-[3-[[2-(3,4-Dimethoxyphenyl)ethyl]methylamino]propyl]-3,4-dimethoxy-α-(1-methylethyl)benzenecetonitrile Hydrochloride; Verapamil Hydrochloride Impurity B
EINECS	Contact for details

Quality Control

Our VERAPAMIL RELATED COMPOUND B is manufactured under strict quality management systems to ensure it meets the exacting standards required for pharmaceutical reference materials. Each batch undergoes rigorous analytical testing, including HPLC purity assay, identity confirmation (IR, MS), and residual solvent analysis, to guarantee traceability and consistency. Comprehensive Certificates of Analysis (COA) with batch-specific data are provided, supporting compliance with ICH Q3A/B, USP, and EP guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. This product is hygroscopic (moisture-sensitive); ensure the container is sealed tightly after each use to prevent degradation from atmospheric moisture.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Assay (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual impurity ≤ 1.0%
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.