Description

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

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Amlodipine Besylate active pharmaceutical ingredient (API) and finished dosage forms.
• Analytical Method Development: Essential for developing and validating sensitive HPLC, UPLC, or LC-MS methods to monitor impurity levels in accordance with ICH Q3A(R2) and Q3B(R2) guidelines.
• Quality Control & Assurance: Serves as a system suitability standard in routine QC testing to ensure the accuracy and precision of impurity assays.
• Stability Studies: Employed to track the formation of this specific degradation product under various stress conditions (e.g., heat, light, humidity) during drug stability testing.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., FDA, EMA) to establish impurity thresholds and justify specifications.
• Research & Development: Used in pharmacokinetic and metabolic studies to understand the degradation pathways of Amlodipine.

Basic Information

Product Name	Amlodipine Impurity M
CAS No.	906098-03-1
Molecular Formula	C26H31ClN2O8S
Molecular Weight	567.05 g/mol
Synonyms	3-Ethyl 5-Methyl (4RS)-2-[(2-Aminoethoxy)methyl]-4-(2-chlorophenyl)-6-methyl-1,4-dihydro-3,5-pyridinedicarboxylate Benzenesulfonate; Amlodipine Besylate Impurity M; Amlodipine Related Compound M; 3-Ethyl 5-methyl 4-(2-chlorophenyl)-2-[(2-aminoethoxy)methyl]-6-methyl-1,4-dihydro-3,5-pyridinedicarboxylate benzenesulfonate; Amlodipine Sulfonate Ester Impurity.
EINECS	Contact for details

Quality Control

Every batch of Amlodipine Impurity M is manufactured and analyzed under strict quality management systems. Our products undergo rigorous quality testing, including advanced chromatographic and spectroscopic techniques, to ensure compliance with pharmaceutical reference standard requirements. Comprehensive Certificates of Analysis (COA) detailing purity, identity, and impurity profiles are provided and available upon request.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. This material is hygroscopic (moisture-sensitive) and should be handled under anhydrous conditions 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 impurity ≤ 0.5%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

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