Description

Amlodipine Impurity 64 is a high-purity chemical reference standard used for the analytical profiling and quality control of the active pharmaceutical ingredient (API) Amlodipine. This compound is critical for pharmaceutical manufacturers and research laboratories to ensure product safety, regulatory compliance, and batch-to-batch consistency. It serves as a key marker for identifying and quantifying specific process-related impurities during drug development and production.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material for the identification and quantification of Amlodipine-related impurities in compliance with ICH Q3A/B guidelines.
• Analytical Method Development & Validation: Essential for developing, calibrating, and validating HPLC, UPLC, and LC-MS methods in quality control laboratories.
• Pharmaceutical R&D: Used in stability studies, forced degradation studies, and impurity profiling during the drug development lifecycle.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., for FDA, EMA) by providing necessary impurity characterization data for drug master files (DMFs).
• Quality Assurance/Quality Control (QA/QC): Routine testing of Amlodipine API and finished dosage forms to monitor impurity levels and ensure specifications are met.
• Contract Research Organizations (CROs): Outsourced analytical testing and impurity isolation services for pharmaceutical clients.

Basic Information

Item	Detail
Product Name	Amlodipine Impurity 64
CAS No.	2387405-44-7
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Amlodipine Related Compound 64; Amlodipine Impurity R; Amlodipine Process Impurity 64; 3-Ethyl 5-Methyl 4-(2-Chlorophenyl)-2-[(2-Aminoethoxy)methyl]-6-methyl-1,4-dihydropyridine-3,5-dicarboxylate Impurity; 1,4-Dihydropyridine Derivative Impurity; Amlodipine Besylate Impurity 64; Norvasc Impurity
EINECS	Contact for details

Quality Control

Our Amlodipine Impurity 64 is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including chromatographic purity analysis and structural confirmation, to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing purity, identity, and analytical methods.

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 material is hygroscopic (moisture-sensitive) and must be kept in a desiccated environment to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0%
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C

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