Description

Amlodipine Impurity 9 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of the active pharmaceutical ingredient (API) Amlodipine Besylate. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and impurity profiling studies.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference material (CRM) to identify, quantify, and control this specific impurity in Amlodipine Besylate API and finished dosage forms.
• Analytical Method Development & Validation: Serves as a critical standard for developing and validating HPLC, UPLC, or LC-MS methods to ensure accurate detection and quantification limits.
• Quality Control & Assurance (QC/QA): Employed in routine quality control testing of Amlodipine batches to monitor impurity levels against ICH Q3A/B guidelines.
• Regulatory Submissions: Essential for preparing regulatory documentation (e.g., for FDA, EMA) to establish impurity thresholds and justify specifications.
• Stability Studies: Used to track the formation of this impurity in Amlodipine products under various stress and long-term storage conditions.
• Research & Development: Aids in synthetic route optimization and degradation pathway studies for Amlodipine and related compounds.

Basic Information

Product Name	Amlodipine Impurity 9
CAS No.	90445-05-9
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 9; Amlodipine Related Compound 9; 3-Ethyl 5-methyl 2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-6-methyl-1,4-dihydropyridine-3,5-dicarboxylate benzenesulfonate; Amlodipine Benzenesulfonate Impurity 9; Amlodipine Sulfonate Impurity 9
EINECS	Contact for details

Quality Control

Every batch of Amlodipine Impurity 9 is manufactured and tested under strict quality management systems. Our products undergo rigorous analytical testing, including HPLC, LC-MS, and NMR, to ensure high purity and structural identity in compliance with ICH guidelines. A comprehensive Certificate of Analysis (COA) detailing purity, impurities, and analytical methods is provided with each shipment.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and must be kept in a desiccated environment to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white powder
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 unknown impurity ≤ 0.5%
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.