Description

Amlodipine Metabolite 5 is a key intermediate and reference standard in the synthesis and analytical profiling of the widely prescribed calcium channel blocker, amlodipine. This compound is critical for pharmaceutical research and development, enabling precise metabolic studies, impurity characterization, and quality control of the active pharmaceutical ingredient. It is primarily utilized by pharmaceutical manufacturers, contract research organizations (CROs), and analytical laboratories engaged in drug development and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Used as a certified standard for the identification and quantification of amlodipine-related impurities and degradation products in compliance with ICH guidelines.
• Metabolic Pathway Research: Essential for in vitro and in vivo studies to understand the biotransformation and pharmacokinetics of amlodipine.
• Analytical Method Development: Serves as a critical component in developing and validating HPLC, LC-MS, and GC-MS methods for drug analysis.
• Quality Control & Assurance: Employed in impurity profiling and stability testing of amlodipine besylate active pharmaceutical ingredient (API) and finished dosage forms.
• Synthetic Intermediate: Used in the research-scale synthesis of amlodipine and its structural analogs for medicinal chemistry programs.

Basic Information

Product Name	Amlodipine Metabolite 5
CAS No.	114018-75-6
Molecular Formula	C20H25ClN2O5
Molecular Weight	408.88 g/mol
Synonyms	3-Ethyl 5-Methyl 2-[(2-Aminoethoxy)methyl]-4-(2-chlorophenyl)-6-methyl-1,4-dihydropyridine-3,5-dicarboxylate; Amlodipine Impurity; Amlodipine Related Compound; 1,4-Dihydro-2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-6-methyl-3,5-pyridinedicarboxylic Acid 3-Ethyl 5-Methyl Ester; Amlodipine Metabolite; Amlodipine Degradant
EINECS	Contact for details

Quality Control

Our Amlodipine Metabolite 5 is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including identification by spectroscopic methods (IR, NMR, MS), purity assay by HPLC, and control of specified impurities. A detailed Certificate of Analysis (COA) is provided with each shipment, ensuring traceability and compliance with relevant standards for pharmaceutical reference materials.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. For long-term storage, consider storing under inert atmosphere at 2-8°C to ensure maximum stability.

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)	Total impurities ≤ 2.0% Any single impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 0.5%

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