Description

Verapamil Impurity H is a high-purity reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and efficacy of the cardiovascular drug Verapamil by enabling accurate identification and quantification of related substances. It is an essential material for pharmaceutical R&D laboratories, quality control (QC) departments, and regulatory compliance teams focused on impurity profiling and method validation.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of Verapamil Impurity H in active pharmaceutical ingredients (APIs) and finished drug products.
• Analytical Method Development & Validation: Used to develop, optimize, and validate chromatographic methods, such as HPLC and UPLC, for impurity profiling.
• Quality Control & Assurance: Serves as a system suitability standard in routine QC testing to monitor batch-to-batch consistency and ensure compliance with pharmacopeial limits (e.g., ICH Q3A/B).
• Regulatory Submissions: Supports the preparation of regulatory documentation (e.g., for FDA, EMA) by providing characterized impurity samples for stability studies and specification setting.
• Research & Degradation Studies: Employed in forced degradation studies to understand the stability profile of Verapamil and to identify potential degradation pathways.
• Calibration & Qualification: Used to calibrate analytical instruments and qualify testing procedures in GMP/GLP environments.

Basic Information

Product Name	Verapamil Impurity H
CAS No.	67018-83-1
Molecular Formula	C27H38N2O4
Molecular Weight	454.60 g/mol
Synonyms	5-[(3,4-Dimethoxyphenethyl)methylamino]-2-(3,4-dimethoxyphenyl)-2-isopropylvaleronitrile; Verapamil Impurity 8; Verapamil Related Compound H; (±)-Verapamil Impurity H; α-[3-[[2-(3,4-Dimethoxyphenyl)ethyl]methylamino]propyl]-3,4-dimethoxy-α-(1-methylethyl)benzenepropanenitrile
EINECS	Contact for details

Quality Control

Our Verapamil Impurity H is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity and identity confirmation (IR, NMR), to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with every shipment.

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 low-humidity environment to maintain stability and purity.

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)	Individual unknown 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.