Description

Amlodipine Impurity 58 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 Besylate. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and research institutions engaged in method development, stability studies, and impurity profiling.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference standard for the identification and quantification of specific impurities in Amlodipine Besylate API and finished dosage forms.
• Analytical Method Development and Validation: Serves as a critical component in developing, optimizing, and validating HPLC, UPLC, or LC-MS methods for impurity analysis.
• Quality Control (QC) and Quality Assurance (QA): Employed in routine batch testing within pharmaceutical QC laboratories to monitor impurity levels against ICH guidelines.
• Stability Studies: Used to track the formation and growth of this specific impurity during forced degradation and long-term stability testing of drug products.
• Regulatory Compliance and Documentation: Essential for preparing regulatory submission dossiers (e.g., for FDA, EMA) that require detailed impurity characterization data.
• Research and Development (R&D): Utilized in pharmaceutical R&D to study degradation pathways and the chemical behavior of Amlodipine.

Basic Information

Product Name	Amlodipine Impurity 58
CAS No.	2170104-02-4
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Amlodipine Related Compound 58; Amlodipine Besylate Impurity 58; Amlodipine Specified Impurity 58; 3-Ethyl 5-Methyl (4RS)-2-[(2-Aminoethoxy)methyl]-4-(2-chlorophenyl)-6-methyl-1,4-dihydro-3,5-pyridinedicarboxylate Impurity; 1,4-Dihydro-2,6-dimethyl-4-(2-chlorophenyl)-3,5-pyridinedicarboxylic acid 3-ethyl 5-methyl ester impurity; Amlodipine Process Impurity; Amlodipine Degradant
EINECS	Contact for details

Quality Control

Our Amlodipine Impurity 58 is manufactured under strict quality control protocols. Each batch is thoroughly characterized and tested using advanced analytical techniques such as HPLC, GC, MS, and NMR to ensure high purity and accurate identification. We provide comprehensive Certificates of Analysis (COA) with detailed chromatographic and spectroscopic data, supporting compliance with ICH Q3A/B guidelines for pharmaceutical impurities.

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 must be kept under inert conditions or in a desiccator after opening to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms
Identification (MS)	Conforms
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity ≤ 1.0% Total impurities ≤ 5.0%
Residual Solvents (GC)	Complies with ICH limits
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.