Description

Amlodipine Di-Phthalimide Impurity is a key chemical reference standard used in the analytical profiling and quality control of Amlodipine, a widely prescribed calcium channel blocker. This impurity is critical for pharmaceutical manufacturers and research laboratories to ensure drug purity, safety, and regulatory compliance. It is primarily utilized by professionals in pharmaceutical R&D, quality assurance, and analytical chemistry for method development and validation.

Application

• Pharmaceutical Impurity Reference Standard: Serves as a certified reference material (CRM) for the identification and quantification of related substances in Amlodipine Active Pharmaceutical Ingredient (API) and finished dosage forms.
• Analytical Method Development & Validation: Essential for developing, calibrating, and validating High-Performance Liquid Chromatography (HPLC) and other chromatographic methods in QC laboratories.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., for FDA, EMA) by providing necessary impurity data for drug master files (DMFs) and investigational new drug (IND) applications.
• Stability Studies & Forced Degradation Testing: Used to monitor and identify potential degradation products formed under various stress conditions (light, heat, humidity) during drug stability studies.
• Pharmacopoeial Testing: Aids in compliance testing against monographs in pharmacopoeias such as USP, EP, and BP, which set strict limits for known and unknown impurities.
• Academic & Contract Research: Employed in university and CRO (Contract Research Organization) settings for research into pharmaceutical synthesis pathways, impurity formation mechanisms, and analytical science.

Basic Information

Product Name	Amlodipine Di-Phthalimide Impurity
CAS No.	223734-98-3
Molecular Formula	C26H23ClN2O5
Molecular Weight	478.93 g/mol
Synonyms	Amlodipine Diphthalimide Impurity; Amlodipine Bis-phthalimide Impurity; Amlodipine Impurity D (Potential); 3-Ethyl 5-methyl 4-(2-chlorophenyl)-2-[(2-phthalimido)ethoxy]methyl]-6-methyl-1,4-dihydropyridine-3,5-dicarboxylate; 1,4-Dihydro-2,6-dimethyl-4-(2-chlorophenyl)-3,5-pyridinedicarboxylic acid 3-ethyl 5-methyl ester 2-[(2-phthalimido)ethoxy]methyl] derivative; Amlodipine Related Compound D; Amlodipine Phthalimide Derivative
EINECS	Contact for details

Quality Control

Our Amlodipine Di-Phthalimide Impurity is manufactured under strict quality systems to ensure high purity and batch-to-batch consistency, suitable for use as a reference standard. Each batch is fully characterized and undergoes rigorous analytical testing, including HPLC for purity and identity confirmation via spectroscopic methods. A comprehensive Certificate of Analysis (COA) is provided, detailing purity, assay results, and chromatographic data. Our quality commitment aligns with the standards expected for pharmaceutical impurity standards, supporting compliance with ICH Q3A/B guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a cool, dry place. This compound is hygroscopic (moisture-sensitive); therefore, the container must be kept tightly sealed to minimize exposure to atmospheric humidity. For long-term storage, consider desiccants.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Single unknown impurity ≤ 0.5% Total impurities ≤ 2.0%
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.