Description

Amlodipine Impurity 38 is a designated reference standard used in the analytical profiling and quality control of Amlodipine Besylate, a widely prescribed calcium channel blocker. This compound is critical for pharmaceutical manufacturers and research laboratories to ensure drug purity, safety, and regulatory compliance. It serves as an essential tool for method development, validation, and stability studies in the production of cardiovascular medications.

Application

• Pharmaceutical Reference Standard: Primary use as a certified impurity standard for the identification and quantification of related substances in Amlodipine Besylate Active Pharmaceutical Ingredient (API) and finished dosage forms.
• Analytical Method Development & Validation: Essential for developing and validating HPLC, UPLC, and other chromatographic methods to monitor impurities during the drug manufacturing process.
• Quality Control & Assurance (QC/QA): Used in routine batch release testing to ensure Amlodipine products meet stringent pharmacopeial specifications (e.g., USP, EP, ICH guidelines) for impurity limits.
• Stability Studies: Employed to track the formation of degradation products under various stress conditions (e.g., heat, light, humidity) to establish drug shelf-life.
• Regulatory Compliance & Documentation: Provides necessary data for regulatory filings (e.g., FDA, EMA) to demonstrate thorough impurity characterization and control strategies.
• Research & Development: Utilized in synthetic chemistry research to understand degradation pathways and to synthesize purer forms of the API.

Basic Information

Product Name	Amlodipine Impurity 38
CAS No.	135969-53-8
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-dihydropyridine-3,5-dicarboxylate Benzenesulfonate; Amlodipine Besylate Impurity 38; Amlodipine Related Compound 38; 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 38
EINECS	Contact for details

Quality Control

Every batch of Amlodipine Impurity 38 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing using advanced analytical techniques (HPLC, GC, NMR, MS) to ensure compliance with industry and pharmacopeial standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results.

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. The container should be kept tightly sealed after each use.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual impurity ≤ 1.0%
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.