Description

Amlodipine Impurity K is a high-purity reference standard used in the analytical profiling and quality control of Amlodipine, a widely prescribed calcium channel blocker. This compound is critical for pharmaceutical manufacturers and research laboratories to ensure product safety, efficacy, and regulatory compliance by accurately identifying and quantifying related substances. It is an essential material for method development, validation, and stability studies within the pharmaceutical industry.

Application

• Primary use as a certified reference standard for the quantitative and qualitative analysis of Amlodipine drug substance and finished products.
• Critical component in pharmaceutical research and development for impurity identification and characterization studies.
• Essential for method validation of analytical procedures (e.g., HPLC, UPLC) to meet ICH, USP, and EP guidelines.
• Used in stability testing and forced degradation studies to monitor impurity profiles over time.
• Supports regulatory filings (e.g., ANDA, NDA) by providing definitive impurity data for health authority submissions.
• Valuable for academic and institutional research focusing on cardiovascular drug metabolism and impurity synthesis pathways.
• Employed by quality control (QC) laboratories for routine batch release testing of Amlodipine APIs and formulations.

Basic Information

Item	Detail
Product Name	Amlodipine Impurity K
CAS No.	1809326-44-0
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Amlodipine Related Compound K; Amlodipine Impurity 11; 3-Ethyl 5-Methyl 4-(2-Chlorophenyl)-2-[(2-Aminoethoxy)methyl]-6-methyl-1,4-dihydropyridine-3,5-dicarboxylate Impurity; 1,4-Dihydro-2,6-dimethyl-4-(2-chlorophenyl)-3,5-pyridinedicarboxylic acid 3-ethyl 5-methyl ester impurity; Amlodipine EP Impurity K; Amlodipine USP Impurity K; Amlodipine Process Impurity; (RS)-3-Ethyl 5-methyl 2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-6-methyl-1,4-dihydropyridine-3,5-dicarboxylate Related Substance K
EINECS	Contact for details

Quality Control

Every batch of Amlodipine Impurity K is manufactured and analyzed under strict quality management systems. The product undergoes rigorous testing to ensure identity, purity, and consistency, meeting the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing results from advanced chromatographic and spectroscopic methods. Our quality commitment aligns with cGMP principles and supports compliance with relevant ICH, USP, and EP guidelines.

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 absorption of moisture. For long-term storage, consider using desiccants.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual impurity ≤ 1.0%
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.