Description

Amlodipine Impurity 10 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. It is primarily required by pharmaceutical manufacturers and analytical laboratories for method development, validation, and routine quality control testing. The use of well-characterized impurities is essential for meeting stringent pharmacopeial standards and regulatory requirements.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Amlodipine Besylate and related drug substances.
• Analytical Method Development: Essential for developing and validating HPLC, UPLC, or LC-MS methods in quality control laboratories.
• Regulatory Compliance & Documentation: Supports the preparation of regulatory filings (e.g., ANDA, DMF) by providing necessary impurity profiles for health authorities like the FDA and EMA.
• Stability Studies: Employed to monitor the formation of degradation products in amlodipine formulations under various stress conditions.
• Research & Development: Serves as a key intermediate or impurity marker in the synthesis and process optimization of amlodipine.
• Pharmacopeial Testing: Used to verify compliance with monographs in USP, EP, BP, and other international pharmacopeias.

Basic Information

Product Name	Amlodipine Impurity 10
CAS No.	2170104-51-3
Molecular Formula	C26H31ClN2O8S
Molecular Weight	567.05 g/mol
Synonyms	3-Ethyl 5-Methyl (4RS)-4-(2-Chlorophenyl)-2-[(2-Aminoethoxy)methyl]-6-methyl-1,4-dihydro-3,5-pyridinedicarboxylate Benzenesulfonate; Amlodipine Besylate Impurity 10; Amlodipine Related Compound 10; 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 10
EINECS	Contact for details

Quality Control

Every batch of Amlodipine Impurity 10 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous quality testing to ensure compliance with industry standards. Comprehensive characterization is performed using advanced techniques including HPLC, GC, MS, and NMR. Certificates of Analysis (COA) are available upon request, providing full traceability and detailed analytical results.

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 under inert conditions or in a desiccator to prevent degradation. Keep the container tightly sealed when not in use.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Conforms
Identification (IR)	Conforms to reference spectrum
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Residual Solvents (GC)	Meets ICH Q3C guidelines
Water Content (KF)	≤ 0.5%
Heavy Metals	≤ 20 ppm

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