Description

Amlodipine Impurity 28 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of the active pharmaceutical ingredient (API) Amlodipine Besylate. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and impurity profiling studies.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference material for the identification and quantification of specific impurities in Amlodipine Besylate API and finished dosage forms.
• Analytical Method Development & Validation: Serves as a critical standard for developing and validating HPLC, UPLC, or LC-MS methods to monitor impurities.
• Quality Control & Assurance (QC/QA): Essential for in-process testing and release testing of pharmaceutical batches to meet pharmacopeial standards (USP, EP, ICH).
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., ANDA, NDA) by providing impurity data required by FDA, EMA, and other global health authorities.
• Stability Studies: Employed to track the formation of degradation products in Amlodipine formulations under various stress conditions.
• Research & Development: Used in academic and industrial R&D to study the degradation pathways and chemistry of Amlodipine.

Basic Information

Product Name	Amlodipine Impurity 28
CAS No.	79781-21-8
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-dihydro-3,5-pyridinedicarboxylate Benzenesulfonate; Amlodipine Besylate Related Compound; Amlodipine Sulfonate Ester Impurity; 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 Ester
EINECS	Contact for details

Quality Control

Every batch of Amlodipine Impurity 28 is manufactured and tested under strict quality management systems. Our products undergo rigorous analytical testing, including HPLC, NMR, and MS, to ensure identity, purity, and compliance with industry standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing all test results against established specifications.

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.

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 single 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.