Description

Amlodipine Impurity 49 is a high-purity chemical reference standard used in pharmaceutical research and development. This compound is critical for the quality control and regulatory compliance of Amlodipine Besylate, a widely prescribed calcium channel blocker. It is primarily required by analytical laboratories and pharmaceutical manufacturers for method development, validation, and impurity profiling studies. Ensuring the integrity of this impurity standard is fundamental to guaranteeing the safety and efficacy of the final drug product.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference material (CRM) for the identification and quantification of specific impurities in Amlodipine Besylate active pharmaceutical ingredient (API) and finished dosage forms.
• Analytical Method Development & Validation: Serves as a critical standard for developing, optimizing, and validating stability-indicating HPLC, UPLC, or LC-MS methods.
• Regulatory Compliance & Submissions: Essential for preparing regulatory documentation (e.g., for FDA, EMA, ICH) to establish impurity limits and demonstrate control strategies in accordance with ICH Q3A and Q3B guidelines.
• Stability Studies: Employed as a marker to monitor the formation of degradation products under various stress conditions (thermal, photolytic, hydrolytic) during drug stability testing.
• Quality Control (QC) Testing: Used in routine QC laboratories as a system suitability standard and for the accurate assay of related substances in batch release testing.
• Research & Development: Supports synthetic chemistry research aimed at understanding impurity formation pathways and developing robust purification processes.

Basic Information

Product Name	Amlodipine Impurity 49
CAS No.	79781-18-3
Molecular Formula	C26H31ClN2O8S
Molecular Weight	567.05 g/mol
Synonyms	Ethyl 4-(2-chlorophenyl)-2-[(2RS)-2-[[(2-aminoethoxy)carbonyl]amino]-3-oxo-3-phenoxypropyl]-6-methyl-1,4-dihydropyridine-3,5-dicarboxylate benzene sulfonate; Amlodipine Besylate Impurity 49; Amlodipine Related Compound 49; Amlodipine Besylate Related Substance 49; Amlodipine Impurity K (as per some pharmacopeial nomenclature); Ethyl 4-(2-chlorophenyl)-2-[(2RS)-2-[[(2-aminoethoxy)carbonyl]amino]-3-oxo-3-phenoxypropyl]-6-methyl-1,4-dihydropyridine-3,5-dicarboxylate benzenesulfonate; Amlodipine Benzenesulfonate Impurity 49
EINECS	Contact for details

Quality Control

Our Amlodipine Impurity 49 is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity, NMR and MS for structural confirmation, and residual solvent analysis. We provide comprehensive Certificates of Analysis (COA) with detailed chromatographic data, ensuring traceability and compliance with ICH guidelines and current Good Manufacturing Practice (cGMP) principles for pharmaceutical reference standards.

Storage

Preserve in a tightly closed container, protected from light. Store at a controlled room temperature of 15-25°C. This material is hygroscopic (moisture-sensitive) and must be kept in a dry environment. For long-term storage, consider desiccation.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Water Content (KF)	≤ 1.0%
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.