Description

Amlodipine Impurity 31 is a high-purity chemical reference standard used in the research, development, and quality control of the active pharmaceutical ingredient (API) amlodipine. This compound is critical for ensuring the safety and efficacy of cardiovascular medications by enabling the accurate identification, quantification, and control of related substances during manufacturing. It is an essential material for pharmaceutical R&D laboratories, quality assurance departments, and regulatory bodies focused on impurity profiling and method validation.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material for the identification and quantification of Amlodipine Impurity 31 in API and finished drug products.
• Analytical Method Development & Validation: Critical for developing and validating HPLC, UPLC, and LC-MS methods to monitor impurities in amlodipine besylate and other salts.
• Quality Control & Assurance (QC/QA): Used in routine batch testing to ensure amlodipine API and formulations meet stringent pharmacopeial purity specifications (e.g., USP, EP, ICH Q3A/B).
• Stability Studies: Employed to track the formation of degradation products in amlodipine drug substances and products under various stress conditions.
• Regulatory Submissions: Provides necessary data for Drug Master Files (DMFs), Common Technical Documents (CTDs), and other regulatory filings to demonstrate comprehensive impurity control.
• Process Chemistry Research: Aids in understanding and optimizing the synthesis pathway of amlodipine to minimize the formation of this specific impurity.

Basic Information

Item	Details
Product Name	Amlodipine Impurity 31
CAS No.	496024-43-2
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	3-Ethyl 5-Methyl 4-(2-Chlorophenyl)-2-[(2-Aminoethoxy)methyl]-6-methyl-1,4-dihydropyridine-3,5-dicarboxylate; Amlodipine Chlorophenyl Impurity; Amlodipine Related Compound 31; 1,4-Dihydro-2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-6-methyl-3,5-pyridinedicarboxylic acid 3-ethyl 5-methyl ester; Amlodipine EP Impurity G; Amlodipine Impurity G (EP); 2-[(2-Aminoethoxy)methyl]-4-(2-chlorophenyl)-1,4-dihydro-6-methyl-3,5-pyridinedicarboxylic acid 3-ethyl 5-methyl ester
EINECS	Contact for details

Quality Control

Every batch of Amlodipine Impurity 31 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing using advanced analytical techniques such as HPLC, GC, NMR, and mass spectrometry to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results. We support compliance with ICH Q3A, Q3B, USP, and EP guidelines for impurities in new drug substances and products.

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 should be handled in a dry environment to prevent degradation. For long-term storage, consider desiccants or inert atmosphere conditions.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any single unknown impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 5.0% w/w

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