Description

Verapamil Impurity P is a high-purity chemical reference standard specifically used in the pharmaceutical development and quality control of Verapamil hydrochloride. This compound is critical for ensuring the safety, efficacy, and regulatory compliance of the final drug product by accurately identifying and quantifying related substances. It is an essential material for analytical laboratories, research institutions, and pharmaceutical manufacturers focused on cardiovascular drug development and impurity profiling.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of Verapamil Impurity P in active pharmaceutical ingredients (APIs) and finished dosage forms.
• Analytical Method Development & Validation: Critical for developing, validating, and transferring HPLC, UPLC, or LC-MS methods for impurity analysis in compliance with ICH Q3A(R2) and Q3B(R2) guidelines.
• Quality Control & Assurance (QC/QA): Used in routine batch release testing to monitor impurity levels and ensure drug product specifications are consistently met.
• Stability Studies: Employed to track the formation of degradation products in Verapamil formulations under various stress conditions (e.g., heat, light, humidity).
• Regulatory Submissions: Provides essential data for impurity identification and qualification reports required for regulatory filings with agencies like the FDA, EMA, and PMDA.
• Research & Development: Supports synthetic route optimization, process chemistry studies, and impurity fate and tolerance investigations during drug development.

Basic Information

Product Name	Verapamil Impurity P
CAS No.	2086275-13-8
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Verapamil Related Compound P; Verapamil EP Impurity P; Verapamil USP Impurity P; 5-[(3,4-Dimethoxyphenethyl)methylamino]-2-(3,4-dimethoxyphenyl)-2-isopropylvaleronitrile Impurity; (RS)-Verapamil Impurity P; (±)-Verapamil Impurity P; Verapamil Hydrochloride Impurity P
EINECS	Contact for details

Quality Control

Every batch of Verapamil Impurity P is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing using advanced chromatographic (HPLC, UPLC) and spectroscopic (NMR, MS) techniques to ensure compliance with pharmacopeial standards (USP, EP) and customer-specific requirements. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the certificate of analysis/label. Keep the container in a dry, cool, and well-ventilated place. For long-term storage, consider storing under inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms
Identification (IR)	Conforms to reference spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 5.0%

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