Description

Amlodipine Impurity 1 is a high-purity reference standard used for the analytical profiling and quality control of the active pharmaceutical ingredient (API) Amlodipine. This compound is critical for ensuring the safety, efficacy, and regulatory compliance of cardiovascular medications by accurately identifying and quantifying related substances. It is an essential material for pharmaceutical R&D laboratories, quality assurance/quality control (QA/QC) units, and regulatory affairs departments focused on impurity identification and method validation.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of impurities in Amlodipine Besylate and other Amlodipine salt forms.
• Analytical Method Development & Validation: Critical for developing, validating, and transferring HPLC, UPLC, and LC-MS methods in compliance with ICH Q2(R1) and Q3B(R2) guidelines.
• Stability Studies & Forced Degradation: Used to monitor the formation of this specific impurity during stability testing of drug substances and products under various stress conditions (e.g., heat, light, humidity).
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., ANDA, NDA, CTA) to demonstrate comprehensive impurity control strategies to agencies like the US FDA and EMA.
• Quality Control & Batch Release: Serves as a system suitability and identification standard in routine QC testing to ensure every batch of Amlodipine API meets stringent purity specifications.
• Pharmacopoeial Testing: Supports testing against monographs in the United States Pharmacopeia (USP), European Pharmacopoeia (Ph. Eur.), and other international compendia.

Basic Information

Product Name	Amlodipine Impurity 1
CAS No.	130160-97-3
Molecular Formula	C26H31ClN2O8S
Molecular Weight	567.05 g/mol
Synonyms	3-Ethyl 5-Methyl 4-(2-Chlorophenyl)-2-[(2-Aminoethoxy)methyl]-6-methyl-1,4-dihydropyridine-3,5-dicarboxylate Benzenesulfonate; Amlodipine Besylate Impurity 1; Amlodipine Related Compound A; Amlodipine Benzenesulfonate Impurity 1; 1,4-Dihydro-2,6-dimethyl-4-(2-chlorophenyl)-3,5-pyridinedicarboxylic acid 3-ethyl 5-methyl ester 2-[(2-aminoethoxy)methyl] benzenesulfonate; Norvasc Impurity 1
EINECS	Contact for details

Quality Control

Every batch of Amlodipine Impurity 1 is manufactured and analyzed under strict quality management systems. Identity, purity, and impurity profile are confirmed using orthogonal analytical techniques including HPLC, LC-MS, NMR, and IR spectroscopy. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results against established specifications. Our quality commitment aligns with cGMP principles and supports compliance with ICH guidelines for impurities in new drug substances (Q3A(R2)).

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, 15-25°C (59-77°F). This material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation. For long-term storage, consider desiccant conditions.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual unknown impurity ≤ 0.5%
Water Content (KF)	≤ 1.0% w/w
Residue on Ignition	≤ 0.1%

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