Description

Amlodipine Impurity 47 is a high-purity chemical 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 related substances. It is an essential tool for method development, validation, and stability studies in the production of cardiovascular medications.

Application

• Pharmaceutical Reference Standard: Primary application as a certified impurity standard for the quality control of Amlodipine besylate and other Amlodipine salt forms.
• Analytical Method Development: Used in HPLC, UPLC, and LC-MS methods to establish retention times, response factors, and separation protocols.
• Regulatory Compliance & Documentation: Supports the creation of regulatory submission documents (e.g., for FDA, EMA) by providing definitive impurity characterization data.
• Stability Indicating Method: Employed in forced degradation studies to monitor the formation of this specific impurity under various stress conditions.
• Pharmacopoeial Testing: Aids in compliance testing against monographs in USP, EP, and other international pharmacopoeias.
• Research & Development: Serves as a key intermediate or marker in synthetic route optimization and impurity fate and tolerance studies.

Basic Information

Product Name	Amlodipine Impurity 47
CAS No.	194472-15-6
Molecular Formula	C26H31ClN2O8S
Molecular Weight	567.05 g/mol
Synonyms	(3R,5S)-Ethyl 7-(4-(2-(benzenesulfonamido)ethoxy)phenyl)-5-methoxy-2-oxo-3-(2-oxo-2-phenylethoxy)-3,5-dihydro-2H-pyrano[3,2-c]pyridine-6-carboxylate; Amlodipine Benzenesulfonamide Impurity; Amlodipine Related Compound 47; Amlodipine EP Impurity I; Amlodipine USP Impurity; 194472-15-6; Amlodipine Sulfonamide Impurity.
EINECS	Contact for details

Quality Control

Every batch of Amlodipine Impurity 47 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced chromatographic and spectroscopic techniques (HPLC, GC, NMR, MS) to ensure compliance with pharmacopoeial and customer-specific standards. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. The material is light-sensitive and should be handled under appropriate conditions to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time matches reference standard
Identification (IR)	Spectrum conforms to reference spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any individual unknown impurity ≤ 1.0%
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.