Description

Amlodipine Aspartic Acid Impurity is a high-purity reference standard critical for pharmaceutical research and development. This compound is essential for the identification, qualification, and control of process-related impurities in the manufacturing of Amlodipine besylate, a widely prescribed calcium channel blocker. It serves as a vital tool for analytical chemists and quality assurance professionals in the pharmaceutical industry. The availability of this well-characterized impurity standard is fundamental for ensuring drug safety, efficacy, and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for analytical method development and validation in API (Active Pharmaceutical Ingredient) quality control.
• Impurity Profiling: Identification and quantification of this specific impurity in Amlodipine besylate drug substances and finished dosage forms using techniques like HPLC and LC-MS.
• Regulatory Compliance & Filing: Supporting regulatory submissions (e.g., to FDA, EMA) by providing necessary impurity data for drug master files (DMFs) and investigational new drug (IND) applications.
• Process Chemistry Research: Used in route scouting and process optimization studies to understand and minimize the formation of this impurity during Amlodipine synthesis.
• Stability Studies: Acting as a marker to monitor potential degradation pathways in Amlodipine formulations under various stress conditions.
• Quality Control Laboratories: Routine use in in-house QC testing to ensure batch-to-batch consistency and that impurity levels remain within International Council for Harmonisation (ICH) guidelines.

Basic Information

Product Name	Amlodipine Aspartic Acid Impurity
CAS No.	400602-35-9
Molecular Formula	C26H31ClN2O8S
Molecular Weight	567.06 g/mol
Synonyms	3-Ethyl 5-methyl (4RS)-2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-6-methyl-1,4-dihydropyridine-3,5-dicarboxylate aspartate; Amlodipine Aspartate; Amlodipine Aspartic Acid Salt; Amlodipine Hydrogen Aspartate; Norvasc Impurity (Aspartic Acid adduct); 1,4-Dihydro-2,6-dimethyl-4-(2-chlorophenyl)-3,5-pyridinedicarboxylic acid 3-ethyl 5-methyl ester compound with L-aspartic acid (1:1)
EINECS	Contact for details

Quality Control

Every batch of Amlodipine Aspartic Acid Impurity 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 conformity to stringent specifications typical for pharmaceutical reference standards. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment to support your quality and regulatory requirements.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. This material is hygroscopic (moisture-sensitive); ensure the container is sealed after each use to prevent degradation from atmospheric moisture.

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%
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.