Description

Amlodipine Impurity 59 is a high-purity reference standard critical for pharmaceutical research and development. This compound is essential for the accurate identification, quantification, and control of process-related impurities in Amlodipine Besylate active pharmaceutical ingredient (API) manufacturing. It is primarily used by analytical laboratories and quality control units within pharmaceutical companies and contract research organizations (CROs) to ensure drug safety, efficacy, and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Serves as a certified external standard for calibrating analytical instruments in method development and validation.
• Impurity Profiling & Characterization: Used in HPLC, LC-MS, and GC-MS analyses to identify and quantify this specific impurity in Amlodipine Besylate API batches.
• Quality Control & Assurance (QC/QA): Critical for routine batch release testing to ensure impurity levels remain within ICH Q3A/B regulatory guidelines.
• Stability Studies: Employed to monitor the formation and growth of this impurity in drug products under various stress and storage conditions.
• Regulatory Submissions: Provides necessary data for Drug Master Files (DMFs), Investigational New Drug (IND), and New Drug Application (NDA) filings to health authorities like the FDA and EMA.
• Process Chemistry Research: Aids chemists in understanding and optimizing synthesis pathways to minimize the formation of this impurity.

Basic Information

Product Name	Amlodipine Impurity 59
CAS No.	2170111-18-7
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Amlodipine Related Compound 59; Amlodipine Besylate Impurity 59; 2170111-18-7; Amlodipine Process Impurity; Amlodipine Degradant; Amlodipine Specified Impurity; (R,S)-Amlodipine Impurity 59; 2-[(2-Aminoethoxy)methyl]-4-(2-chlorophenyl)-6-methyl-1,4-dihydropyridine-3,5-dicarboxylic acid 3-ethyl 5-methyl ester impurity (potential structure based on naming conventions)
EINECS	Contact for details

Quality Control

Every batch of Amlodipine Impurity 59 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity confirmation, purity analysis, and impurity profiling using advanced techniques like HPLC, LC-MS, and NMR to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results, and is available upon request.

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 must be kept in a desiccated environment to maintain stability and purity. Handle under an inert atmosphere if necessary to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
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.