Description

Amlodipine Ep Impurity D CAS NO 113994-41-5 is a high-purity chemical reference standard specifically used for analytical and quality control purposes in the pharmaceutical industry. This compound is critical for ensuring the safety and efficacy of the active pharmaceutical ingredient (API) Amlodipine by accurately identifying and quantifying related substances. It is an essential tool for research and development scientists, analytical chemists, and quality assurance professionals working in pharmaceutical manufacturing and regulatory compliance. The availability of this well-characterized impurity is vital for method validation, stability studies, and meeting stringent pharmacopeial requirements.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of impurities in Amlodipine Besylate and other Amlodipine salt forms.
• Analytical Method Development & Validation (HPLC/LC-MS): Crucial for developing, optimizing, and validating chromatographic methods to separate and analyze process-related impurities.
• Quality Control & Assurance (QC/QA): Used in routine batch testing of Amlodipine API to ensure compliance with specifications set by pharmacopeias (e.g., USP, EP, ICH Q3A/B).
• Stability Studies: Employed to monitor the formation of degradation products in Amlodipine drug substances and finished products under various stress conditions.
• Regulatory Submissions: Supports the preparation of regulatory documentation (e.g., CMC sections for FDA, EMA) by providing necessary impurity characterization data.
• Research & Development: Aids in synthetic route development and process optimization by understanding impurity profiles during Amlodipine manufacturing.

Basic Information

Product Name	Amlodipine Ep Impurity D
CAS No.	113994-41-5
Molecular Formula	C20H25ClN2O5
Molecular Weight	408.88 g/mol
Synonyms	Ethyl 3-Ethyl 5-Methyl 4-(2-Chlorophenyl)-2-[(2-Aminoethoxy)methyl]-6-methyl-1,4-dihydropyridine-3,5-dicarboxylate; Amlodipine Impurity D; Amlodipine Related Compound D; 1,4-Dihydro-2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-3-ethoxycarbonyl-5-methoxycarbonyl-6-methylpyridine; Amlodipine EP Impurity D; Amlodipine Besylate Impurity D; 3-Ethyl 5-methyl 2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-6-methyl-1,4-dihydropyridine-3,5-dicarboxylate
EINECS	Contact for details

Quality Control

Every batch of Amlodipine Ep Impurity D is manufactured and analyzed under strict quality management systems. The product undergoes rigorous testing to ensure identity, purity, and consistency, aligning with current pharmacopeial standards (EP, USP) and ICH guidelines. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing results from advanced analytical techniques including HPLC, NMR, and MS. Our commitment to GMP-grade documentation and traceability ensures the material is suitable for regulatory and research applications.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). Due to its hygroscopic (moisture-sensitive) nature, the container must be kept tightly sealed in a dry environment to prevent degradation. For long-term storage, consider desiccants or inert atmosphere conditions.

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)	Any individual impurity ≤ 1.0%
Total Impurities	≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 1.0%

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