Description

Amlodipine Impurity 26 is a high-purity reference standard used for the analytical profiling and quality control of the active pharmaceutical ingredient (API) Amlodipine. This compound is critical for pharmaceutical manufacturers and research laboratories to ensure product safety, efficacy, and regulatory compliance by accurately identifying and quantifying process-related impurities. It is essential for method development, validation, and stability studies within the pharmaceutical industry.

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: Used in developing and validating HPLC, UPLC, and GC methods for impurity profiling in compliance with ICH Q3A(R2) and Q3B(R2) guidelines.
• Quality Control & Assurance (QC/QA): Serves as a system suitability standard and for routine batch release testing of Amlodipine API and finished dosage forms.
• Stability Studies: Employed to monitor the formation of degradation products in Amlodipine formulations under various stress conditions (e.g., heat, humidity, light).
• Regulatory Submissions: Provides essential data for Drug Master Files (DMFs), Common Technical Documents (CTD), and other regulatory filings with agencies like the US FDA and EMA.
• Research & Development: Used in synthetic chemistry research to study the degradation pathways and metabolism of Amlodipine.

Basic Information

Item	Details
Product Name	Amlodipine Impurity 26
CAS No.	107812-86-2
Molecular Formula	C26H31ClN2O8S
Molecular Weight	567.05 g/mol
Synonyms	3-Ethyl 5-Methyl 4-(2-Chlorophenyl)-2-[(2-Aminoethoxy)methyl]-6-methyl-1,4-dihydropyridine-3,5-dicarboxylate Benzenesulfonate; Amlodipine Besylate Impurity 26; Amlodipine Related Compound 26; 1,4-Dihydro-2,6-dimethyl-4-(2-chlorophenyl)-3,5-pyridinedicarboxylic acid 3-ethyl 5-methyl ester 2-[(2-aminoethoxy)methyl] benzenesulfonate; Amlodipine Benzenesulfonate Impurity 26
EINECS	Contact for details

Quality Control

Every batch of Amlodipine Impurity 26 is manufactured under a strict quality management system and undergoes comprehensive analytical characterization. Our products are supplied with a detailed Certificate of Analysis (COA) that includes data from multiple orthogonal techniques such as HPLC, NMR, and Mass Spectrometry to confirm identity and purity. We support compliance with ICH, USP, and EP guidelines for impurity standards. Certificates of Analysis (COA) are available upon request.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or CoA. This material is hygroscopic (moisture-sensitive) and must be kept in a dry environment. For long-term storage, consider desiccant conditions.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0%
Water Content (KF)	≤ 5.0% w/w
Residual Solvents (GC)	Complies with ICH Q3C

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