Description

Amlodipine Impurity 30 is a high-purity chemical reference standard used in the pharmaceutical development and quality control of Amlodipine, a widely prescribed calcium channel blocker. This impurity is critical for ensuring the safety, efficacy, and regulatory compliance of the final drug product by enabling accurate identification and quantification. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and research institutions focused on method validation, stability studies, and impurity profiling.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference material for the identification and quantification of specific impurities in Amlodipine Active Pharmaceutical Ingredient (API) and finished dosage forms.
• Analytical Method Development & Validation: Serves as a critical standard for developing, validating, and calibrating chromatographic methods, such as HPLC and UPLC, to meet ICH guidelines.
• Stability Studies: Employed in forced degradation and long-term stability testing to monitor the formation of this impurity under various stress conditions.
• Quality Control (QC) Testing: Essential for routine batch release testing in pharmaceutical QC laboratories to ensure impurity levels are within specified limits.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., with FDA, EMA) to demonstrate thorough understanding and control of the drug substance's impurity profile.
• Research & Development: Used in synthetic chemistry research to study the degradation pathways and formation mechanisms of Amlodipine-related compounds.

Basic Information

Product Name	Amlodipine Impurity 30
CAS No.	95574-97-3
Molecular Formula	C26H31ClN2O8S
Molecular Weight	567.05 g/mol
Synonyms	3-Ethyl 5-Methyl 4-(2-Chlorophenyl)-2-[[2-[2-(1,3-Dioxoisoindolin-2-yl)ethoxy]ethoxy]methyl]-6-methyl-1,4-dihydropyridine-3,5-dicarboxylate; Amlodipine Naphthalimide Impurity; Amlodipine Related Compound 30; 2-[2-[2-[[4-(2-Chlorophenyl)-3-ethoxycarbonyl-5-methoxycarbonyl-6-methyl-1,4-dihydropyridin-2-yl]methoxy]ethoxy]ethyl]isoindole-1,3-dione; Amlodipine Impurity K; Amlodipine EP Impurity K; Amlodipine USP Related Compound K
EINECS	Contact for details

Quality Control

Every batch of Amlodipine Impurity 30 is manufactured and analyzed under strict quality management systems. The product undergoes rigorous testing to ensure it meets the high-purity standards required for pharmaceutical reference materials, with specifications aligned to relevant pharmacopeial guidelines (e.g., USP, EP). A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing results for identity, purity, and impurity assays conducted via validated methods like HPLC and NMR.

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 should be kept in a desiccated environment to prevent degradation. For long-term storage, consider conditions under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Retention time matches reference standard
Identification (NMR)	Spectrum consistent with structure
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 1.0% w/w

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