Description

Amlodipine Impurity E Maleate is a high-purity chemical reference standard critical for pharmaceutical research and development. This compound serves as a specified impurity in the quality control and validation of Amlodipine, a widely prescribed calcium channel blocker. It is essential for analytical chemists and quality assurance professionals in the pharmaceutical industry to ensure drug safety, efficacy, and regulatory compliance. The precise characterization of this impurity is fundamental for method development, stability studies, and meeting stringent pharmacopeial requirements.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Amlodipine Active Pharmaceutical Ingredients (APIs) and finished dosage forms.
• Analytical Method Development and Validation: Critical for developing, validating, and verifying HPLC, UPLC, and GC methods to ensure specificity, accuracy, and robustness in impurity profiling.
• Quality Control & Assurance (QC/QA): Employed in routine batch testing to monitor impurity levels against International Council for Harmonisation (ICH) guidelines and pharmacopeial limits (USP, EP).
• Stability Studies: Used to track the formation and growth of this specific degradation product under various stress conditions (heat, light, humidity) as part of drug shelf-life determination.
• Regulatory Submissions: Provides essential data for Drug Master Files (DMFs), Investigational New Drug (IND) applications, and New Drug Applications (NDAs) to demonstrate comprehensive impurity control.
• Research and Development: Facilitates studies on the degradation pathways and chemical behavior of Amlodipine, supporting the development of more stable formulations.

Basic Information

Product Name	Amlodipine Impurity E Maleate
CAS No.	400024-12-6
Molecular Formula	C26H31ClN2O8
Molecular Weight	535.0 g/mol (approx.)
Synonyms	Amlodipine Maleate Impurity E; Amlodipine Related Compound E Maleate; 3-Ethyl 5-Methyl 2-[(2-Aminoethoxy)methyl]-4-(2-chlorophenyl)-6-methyl-1,4-dihydropyridine-3,5-dicarboxylate Maleate; 1,4-Dihydro-2,6-dimethyl-4-(2-chlorophenyl)-3,5-pyridinedicarboxylic acid 3-ethyl 5-methyl ester compound with (Z)-2-butenedioic acid (1:1); Amlodipine EP Impurity E Maleate; Amlodipine USP Impurity E Maleate
EINECS	Contact for details

Quality Control

Every batch of Amlodipine Impurity E Maleate is manufactured and analyzed under strict quality management systems. Our products undergo rigorous quality testing to ensure compliance with industry standards, including identity confirmation via spectroscopic methods (IR, NMR, MS), purity assessment by HPLC, and control of related substances. Certificates of Analysis (COA) detailing batch-specific results are available upon request, providing full traceability and supporting your regulatory needs.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or COA. This material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation. For long-term storage, consider desiccants or inert atmosphere.

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%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 1.0% w/w

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