Description

Amlodipine Impurity 48 is a high-purity chemical reference standard used in the analytical profiling and quality control of the active pharmaceutical ingredient (API) Amlodipine. 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 fine chemical sectors.

Application

• Pharmaceutical Reference Standard: Primary use as a certified impurity standard for the quality control of Amlodipine besylate and other Amlodipine salt APIs.
• Analytical Method Development & Validation: Used in HPLC, UPLC, and LC-MS methods to establish system suitability, specificity, and detection limits.
• Stability Indicating Studies: Employed to monitor the formation of degradation products in Amlodipine formulations under various stress conditions.
• Regulatory Compliance & Documentation: Supports the preparation of regulatory submission dossiers (e.g., for FDA, EMA) by providing definitive impurity identification data.
• Research & Development: Serves as a key intermediate or marker in synthetic pathway studies and process chemistry optimization for Amlodipine production.
• Contract Research & Testing Laboratories (CROs/CTLs): Essential for third-party testing services offering impurity profiling and batch release testing.

Basic Information

Product Name	Amlodipine Impurity 48
CAS No.	39562-06-6
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 48; Amlodipine Related Compound 48; 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.
EINECS	Contact for details

Quality Control

Every batch of Amlodipine Impurity 48 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and strength testing to ensure compliance with ICH Q3A/B guidelines and other relevant pharmacopeial standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing the results of all analytical tests, including chromatographic purity, assay, and structural confirmation.

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. For long-term storage, consider storing under an inert atmosphere.

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%
Assay	97.0% - 103.0% (on anhydrous basis)
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%
Heavy Metals	≤ 20 ppm

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