Description

Amlodipine Impurity D is a designated pharmaceutical reference standard used for the identification, qualification, and quantification of related substances in Amlodipine Besylate active pharmaceutical ingredient (API) and finished drug products. This high-purity impurity is critical for ensuring the safety, efficacy, and regulatory compliance of cardiovascular medications. It is an essential material for pharmaceutical R&D laboratories, quality control (QC) units, and regulatory affairs departments focused on method development, validation, and stability studies.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for analytical method development and validation in accordance with ICH Q2(R1) and Q3B(R2) guidelines.
• Quality Control & Assurance: For the precise identification and quantification of Amlodipine Impurity D in Amlodipine Besylate API batches to ensure they meet pharmacopeial (USP, EP) purity specifications.
• Stability Indicating Method: Used in forced degradation and long-term stability studies to monitor the formation of this specific degradation product under various stress conditions.
• Regulatory Submissions: Critical for compiling impurity profiles and supporting documentation for Drug Master Files (DMFs), New Drug Applications (NDAs), and Abbreviated New Drug Applications (ANDAs).
• Research & Development: Serves as a key intermediate or marker in synthetic route optimization and impurity fate and tolerance studies during API process development.

Basic Information

Product Name	Amlodipine Impurity D
CAS No.	2138811-33-1
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 D; Amlodipine Related Compound D; 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 D.
EINECS	Contact for details

Quality Control

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

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This compound is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation. For long-term storage, consider desiccants or inert atmosphere.

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 single unknown impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 1.0% w/w
Assay (HPLC)	97.0% - 103.0% on dried basis

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