Description

Verapamil Related Compound D (50 Mg) (5,5'-[[2-(3,4)Dimethoxyphenyl)Ethyl]Imino]Bis[2-(3,4-Dimethoxyphenyl)-2-(1-Methylethyl)Pentaneni-Trile] Hydrochloride) is a high-purity chemical reference standard, essential for the quality control and analytical validation of the calcium channel blocker Verapamil. This compound is critical for ensuring the safety and efficacy of pharmaceutical products by accurately identifying and quantifying process-related impurities. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for research, development, and compliance testing.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference material for the identification and quantification of Verapamil Related Compound D in active pharmaceutical ingredients (APIs) and finished drug products.
• Analytical Method Development & Validation: Serves as a critical standard for developing, calibrating, and validating HPLC, UPLC, and LC-MS methods in compliance with ICH Q2(R1) and USP guidelines.
• Quality Control & Assurance (QC/QA): Essential for routine batch testing in pharmaceutical manufacturing to monitor and control impurity levels, ensuring product consistency and meeting pharmacopeial specifications (USP, EP, JP).
• Stability Studies: Employed to track the formation of degradation impurities in Verapamil formulations under various stress conditions (e.g., heat, light, humidity) as per ICH Q1A(R2).
• Regulatory Submissions: Provides necessary data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs) to demonstrate control over product quality.
• Research & Development: Used in synthetic chemistry research to study the pathways of impurity formation and to develop purer synthesis routes for Verapamil API.

Basic Information

Product Name	Verapamil Related Compound D (50 Mg) (5,5'-[[2-(3,4)Dimethoxyphenyl)Ethyl]Imino]Bis[2-(3,4-Dimethoxyphenyl)-2-(1-Methylethyl)Pentaneni-Trile] Hydrochloride)
CAS No.	190850-50-1
Molecular Formula	C52H68N4O8 • HCl
Molecular Weight	898.57 g/mol (Free base: 862.13 g/mol)
Synonyms	Verapamil Impurity D; Verapamil Related Substance D; 5,5'-[[2-(3,4-Dimethoxyphenyl)ethyl]imino]bis[2-(3,4-dimethoxyphenyl)-4-methyl-2-(1-methylethyl)pentanenitrile] Hydrochloride; Verapamil EP Impurity D; Verapamil USP Related Compound D; NNC 05-2090 hydrochloride; 1-[3-[[2-(3,4-Dimethoxyphenyl)ethyl]methylamino]propyl]-3,4-dimethoxy-α-(1-methylethyl)-α-phenylbenzenepropanenitrile Hydrochloride (alternative naming).
EINECS	Contact for details

Quality Control

Our Verapamil Related Compound D is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC purity assay, identification by IR and MS, residual solvent analysis, and precise water content determination to ensure it meets the stringent requirements for pharmaceutical reference standards. Certificates of Analysis (COA) with detailed chromatographic data and traceable results are provided for every unit, supporting compliance with ICH, USP, and EP 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 must be kept in a desiccated environment to maintain stability and purity. After opening, seal the container immediately under an inert atmosphere if possible.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Any individual impurity ≤ 0.5%; Total impurities ≤ 2.0%
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.