Description

Amlodipine Desfluoro Impurity is a key pharmaceutical reference standard used in the quality control and analytical development of cardiovascular drugs. This compound is critical for ensuring the purity, safety, and efficacy of Amlodipine Besylate and related active pharmaceutical ingredients (APIs). It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method validation, impurity profiling, and compliance testing.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference material for the identification and quantification of desfluoro-related impurities in Amlodipine Besylate API and finished dosage forms.
• Analytical Method Development & Validation (HPLC/LC-MS): Serves as a critical standard for developing, calibrating, and validating chromatographic methods to meet ICH Q3A(R2) and Q3B(R2) guidelines.
• Quality Control & Assurance (QC/QA): Essential for routine batch release testing in pharmaceutical manufacturing to monitor and control impurity levels.
• Regulatory Compliance & Submissions: Supports regulatory filings (e.g., for FDA, EMA) by providing necessary data on impurity characterization and control strategies.
• Stability Studies: Employed to track the formation of degradation products in Amlodipine formulations under various stress conditions.
• Research & Development (R&D): Used in synthetic chemistry research to study the degradation pathways and metabolism of Amlodipine.

Basic Information

Product Name	Amlodipine Desfluoro Impurity
CAS No.	88150-52-1
Molecular Formula	C20H25ClN2O5
Molecular Weight	408.88 g/mol
Synonyms	Desfluoro Amlodipine; Amlodipine Desfluoro Analog; 3-Ethyl 5-Methyl 2-[(2-Aminoethoxy)methyl]-4-(2-chlorophenyl)-6-methyl-1,4-dihydropyridine-3,5-dicarboxylate; 1,4-Dihydro-2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-6-methyl-3,5-pyridinedicarboxylic acid 3-ethyl 5-methyl ester; Amlodipine Related Compound D (as per some pharmacopeial monographs); Norvasc Desfluoro Impurity; Amlodipine Impurity D.
EINECS	Contact for details

Quality Control

Our Amlodipine Desfluoro Impurity is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity, NMR and MS for structural confirmation, and residual solvent analysis to ensure compliance with ICH guidelines and relevant pharmacopeial standards. A comprehensive Certificate of Analysis (COA) detailing identity, purity, and assay is provided with every shipment.

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 should be handled in a dry environment to prevent degradation. For long-term storage, consider desiccated conditions.

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%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 1.0% w/w
Assay (on dried basis)	97.0% - 102.0%

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