Description

Verapamil Related Compound A (50 Mg) (3,4-Dimethoxy-α-[3-(Methylamino)Propyl]-α-(1-Methylethyl)-Benzeneacetonitrile Monohydrochloride) is a high-purity reference standard critical for pharmaceutical research and quality control. This compound is essential for the accurate identification, quantification, and monitoring of impurities in verapamil hydrochloride drug substances and finished products. It is primarily used by analytical laboratories, quality assurance departments, and R&D teams within the pharmaceutical and biotechnology sectors to ensure product safety, efficacy, and regulatory compliance.

Application

• Pharmaceutical Impurity Profiling: Serves as a certified reference material for the identification and quantification of specific impurities in verapamil hydrochloride API and formulations.
• Analytical Method Development & Validation: Used as a critical standard to develop, optimize, and validate HPLC, UPLC, and GC methods for impurity analysis.
• Quality Control (QC) Testing: Employed in routine QC testing of verapamil batches to ensure they meet stringent pharmacopeial (USP, EP, JP) specifications for related substances.
• Stability Studies: Acts as a marker compound in forced degradation and long-term stability studies to track impurity formation over time.
• Regulatory Compliance & Documentation: Provides essential data for regulatory filings (e.g., ANDA, NDA) and audits by demonstrating control over the manufacturing process.
• Research on Drug Metabolism & Degradation Pathways: Used in research settings to study the degradation pathways and metabolic byproducts of verapamil.

Basic Information

Product Name	Verapamil Related Compound A (50 Mg)
CAS No.	67775-97-7
Molecular Formula	C27H39N2O2 • HCl
Molecular Weight	469.07 g/mol
Synonyms	3,4-Dimethoxy-α-[3-(methylamino)propyl]-α-(1-methylethyl)benzeneacetonitrile Monohydrochloride; Verapamil Impurity A; Verapamil Related Substance A; D 519; D-519; α-[3-(Methylamino)propyl]-3,4-dimethoxy-α-(1-methylethyl)benzenecetonitrile Hydrochloride; Benzeneacetonitrile, 3,4-dimethoxy-α-[3-(methylamino)propyl]-α-(1-methylethyl)-, monohydrochloride
EINECS	Contact for details

Quality Control

Every batch of Verapamil Related Compound A is manufactured and analyzed under strict quality management systems. The product undergoes rigorous testing to ensure it meets the high-purity standards required for use as a reference material in pharmaceutical applications. A comprehensive Certificate of Analysis (COA) is provided with each lot, detailing results for identity, purity, and related substances as determined by validated chromatographic methods.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. This compound is hygroscopic (moisture-sensitive) and light-sensitive; prolonged exposure to moisture or light should be avoided to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches 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.