Description

Amlodipine Impurity 42 is a high-purity chemical reference standard used in the analytical profiling and quality control of Amlodipine drug substances and finished pharmaceutical products. This compound is critical for pharmaceutical manufacturers and research laboratories to ensure product safety, efficacy, and regulatory compliance by accurately identifying and quantifying related substances. It is an essential tool for professionals engaged in method development, stability studies, and impurity characterization within the pharmaceutical and analytical chemistry sectors.

Application

• Pharmaceutical Reference Standard: Primary use as a certified impurity standard for the quality control of Amlodipine besylate and other Amlodipine-based active pharmaceutical ingredients (APIs).
• Analytical Method Development & Validation: Used in developing and validating HPLC, UPLC, and GC methods for impurity profiling and assay determination.
• Stability Studies & Forced Degradation: Employed to identify and monitor degradation products formed under various stress conditions (e.g., heat, light, humidity) as per ICH guidelines.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., ANDA, NDA) by providing definitive impurity identification data for health authorities like the FDA and EMA.
• Research & Development: Serves as a key intermediate or marker in synthetic chemistry research and the development of new analytical protocols.
• Calibration & System Suitability: Acts as a calibrant to ensure the precision and accuracy of analytical instrumentation used in quality control laboratories.

Basic Information

Item	Detail
Product Name	Amlodipine Impurity 42
CAS No.	24392-27-6
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 42; Amlodipine Related Compound 42; 1,4-Dihydro-2,6-dimethyl-4-(2-chlorophenyl)-3,5-pyridinedicarboxylic acid 3-ethyl 5-methyl ester 2-[(2-aminoethoxy)methyl] benzenesulfonate; Amlodipine Benzenesulfonate Impurity; Norvasc Impurity; AML Imp 42.
EINECS	Contact for details

Quality Control

Every batch of Amlodipine Impurity 42 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous quality testing, including advanced chromatographic and spectroscopic techniques, to ensure compliance with pharmaceutical reference standard requirements. A comprehensive Certificate of Analysis (COA), detailing purity, identity, and impurity profile, is provided with each shipment to support your regulatory and quality assurance needs.

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 in a desiccated environment to maintain stability and purity. Handle under an inert atmosphere if prolonged exposure is anticipated.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
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.