Description

Amlodipine Impurity F Maleate is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of the active pharmaceutical ingredient (API) amlodipine. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and impurity profiling studies.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the quality control and release testing of Amlodipine API and finished dosage forms.
• Analytical Method Development: Essential for developing and validating HPLC, UPLC, or LC-MS methods to accurately quantify impurities in amlodipine batches.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., ANDA, NDA) by providing definitive identification and characterization data for specified impurities.
• Stability Studies: Employed to monitor the formation of this specific degradation product under various stress conditions during drug product shelf-life studies.
• Research & Development: Used in pharmacokinetic and metabolic studies to understand the impurity's profile and its potential impact.
• Pharmacopoeial Testing: Applied in testing to meet the specifications of pharmacopoeias such as USP, EP, or BP for amlodipine-related substances.

Basic Information

Product Name	Amlodipine Impurity F Maleate
CAS No.	400024-11-5
Molecular Formula	C26H31ClN2O8
Molecular Weight	535.0 g/mol
Synonyms	Amlodipine Maleate Impurity F; Amlodipine Related Compound F Maleate; 3-Ethyl 5-Methyl (4RS)-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, 2-[(2-aminoethoxy)methyl]-, (4R)-, (2Z)-2-butenedioate (1:1); Amlodipine EP Impurity F Maleate; Amlodipine USP Impurity F Maleate; Amlodipine Impurity 6 Maleate (alternative nomenclature).
EINECS	Contact for details

Quality Control

Our Amlodipine Impurity F Maleate is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including identification by spectroscopic methods (IR, NMR, MS), purity determination by HPLC, and control of related substances. A detailed Certificate of Analysis (COA) is provided with each shipment, confirming compliance with in-house specifications aligned with pharmacopoeial standards.

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 dry environment to prevent degradation.

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 individual unspecified impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 1.0%

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