Description

Amlodipine Para-Chloro Impurity (CAS NO 90445-02-6) is a critical pharmaceutical reference standard used in the quality control and development of Amlodipine, a widely prescribed calcium channel blocker. This compound is essential for identifying, quantifying, and controlling a key process-related impurity, ensuring the final drug product meets stringent regulatory purity and safety standards. It is primarily utilized by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method validation, stability studies, and compliance with ICH guidelines.

Application

• Pharmaceutical Reference Standard: Serves as a certified standard for the identification and quantification of the para-chloro impurity in Amlodipine Besylate and Amlodipine Maleate active pharmaceutical ingredients (APIs) and finished dosage forms.
• Analytical Method Development & Validation: Used to develop, optimize, and validate sensitive HPLC, UPLC, and LC-MS methods for impurity profiling in compliance with ICH Q3A(R2) and Q3B(R2) guidelines.
• Quality Control & Batch Release Testing: A critical component in routine QC testing to monitor impurity levels and ensure every batch of Amlodipine API meets the specified pharmacopeial limits (e.g., USP, EP).
• Stability Studies: Employed in forced degradation and long-term stability studies to track the formation of this specific degradant under various stress conditions (e.g., heat, light, humidity).
• Regulatory Submissions: Provides essential data for Drug Master Files (DMFs), Investigational New Drug (IND) applications, and New Drug Applications (NDAs) to demonstrate thorough impurity control strategies.
• Process Chemistry Research: Used by R&D scientists to understand and optimize synthesis pathways to minimize the formation of this impurity during Amlodipine manufacturing.

Basic Information

Product Name	Amlodipine Para-Chloro Impurity
CAS No.	90445-02-6
Molecular Formula	C20H25ClN2O5
Molecular Weight	408.88 g/mol
Synonyms	4-(2-Chlorophenyl)-2-[(2-aminoethoxy)methyl]-6-methyl-1,4-dihydro-3,5-pyridinedicarboxylic acid 3-ethyl 5-methyl ester; Amlodipine Chloro Impurity; Amlodipine Impurity C (Para Isomer); Amlodipine Related Compound C; 2-[(2-Aminoethoxy)methyl]-4-(2-chlorophenyl)-6-methyl-1,4-dihydropyridine-3,5-dicarboxylic acid 3-ethyl 5-methyl ester; Amlodipine 2'-Chloro Analog; Norvasc Impurity
EINECS	Contact for details

Quality Control

Every batch of our Amlodipine Para-Chloro Impurity is manufactured and analyzed under strict quality management systems. The product undergoes rigorous identity confirmation, purity assay, and impurity profiling using advanced chromatographic and spectroscopic techniques (HPLC, GC, NMR, MS) to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results, and our quality systems support compliance with cGMP and ISO guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. The compound is light-sensitive (store away from light) and hygroscopic (moisture-sensitive); therefore, containers should be opened minimally in low-humidity conditions and resealed immediately after use.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 1.0% w/w
Heavy Metals	≤ 20 ppm

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