Description

Amlodipine Impurity 30 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 API manufacturing, ensuring final drug product safety and efficacy. It is primarily used by analytical laboratories, quality control units, and R&D departments within the global pharmaceutical and contract research organization (CRO) sectors to meet stringent regulatory requirements for impurity profiling.

Application

• Pharmaceutical Reference Standard: Serves as a certified external standard for calibrating analytical instruments in impurity quantification.
• Method Development and Validation: Used in developing and validating HPLC, UPLC, or LC-MS methods for impurity detection in Amlodipine Besylate.
• Quality Control & Assurance: Critical for routine batch testing of Active Pharmaceutical Ingredients (APIs) to ensure compliance with ICH Q3A/B guidelines.
• Stability Studies: Employed to monitor and identify degradation products that may form under various stress conditions.
• Regulatory Submissions: Provides necessary data for impurity identification in Drug Master Files (DMFs), ANDAs, and other regulatory filings.
• Process Chemistry Research: Aids in optimizing synthesis pathways by identifying and tracking specific process-related impurities.

Basic Information

Product Name	Amlodipine Impurity 30
CAS No.	1089674-39-4
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Amlodipine Related Compound 30; Amlodipine Besylate Impurity 30; 3-Ethyl 5-Methyl 4-(2-Chlorophenyl)-2-[(2-Aminoethoxy)methyl]-6-methyl-1,4-dihydropyridine-3,5-dicarboxylate Impurity; 1089674-39-4; Amlodipine Process Impurity; Dihydropyridine Impurity
EINECS	Contact for details

Quality Control

Every batch of Amlodipine Impurity 30 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous quality testing, including advanced chromatographic and spectroscopic techniques, to ensure identity, purity, and consistency. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results and confirming compliance with in-house specifications aligned with ICH guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). Due to its hygroscopic (moisture-sensitive) nature, the container must be kept tightly sealed in a dry environment to prevent degradation. For long-term storage, consider desiccants.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time matches reference standard
Identification (IR)	Spectrum conforms to reference
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0%
Single Maximum Unknown Impurity	≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 5.0%

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