Description

3,5-Pyridinedicarboxylic Acid, 2-[(2-Aminoethoxy)Methyl]-4-(2-Chlorophenyl)-1,4-Dihydro-6-Methyl-, 3-Ethyl 5-Methyl Ester, Methanesulfonate, Hydrate (1:1:1) is a high-purity, non-racemic pharmaceutical intermediate of significant commercial and research interest. This compound is valued for its role as a key synthetic precursor in the development of active pharmaceutical ingredients (APIs), particularly in the cardiovascular and metabolic disease therapeutic areas. It is primarily sought after by pharmaceutical R&D laboratories, process chemistry teams, and fine chemical manufacturers engaged in advanced synthesis and scale-up projects.

Application

• Pharmaceutical Intermediate: A critical building block in the multi-step synthesis of complex drug molecules, particularly calcium channel blockers.
• Active Pharmaceutical Ingredient (API) Development: Serves as a precursor in the research and process development for new chemical entities (NCEs).
• Process Chemistry & Scale-Up: Used in optimizing synthetic routes and scaling production from laboratory to pilot and commercial manufacturing.
• Reference Standard: Employed as an analytical standard in quality control (QC) and method development for related APIs and finished dosage forms.
• Biochemical Research: Utilized in pharmacological studies to investigate structure-activity relationships (SAR) and mechanism of action.
• Custom Synthesis: A starting material for the contract synthesis of specialized analogs and derivatives for client-specific research programs.

Basic Information

Product Name	3,5-Pyridinedicarboxylic Acid, 2-[(2-Aminoethoxy)Methyl]-4-(2-Chlorophenyl)-1,4-Dihydro-6-Methyl-, 3-Ethyl 5-Methyl Ester, Methanesulfonate, Hydrate (1:1:1)
CAS No.	440358-84-9
Molecular Formula	C22H29ClN2O5 • CH3SO3H • H2O
Molecular Weight	Contact for details
Synonyms	Lercanidipine Methanesulfonate Hydrate; (R)-Lercanidipine Mesylate Monohydrate; 2-[(2-Aminoethoxy)methyl]-4-(2-chlorophenyl)-1,4-dihydro-6-methyl-3,5-pyridinedicarboxylic acid 3-ethyl 5-methyl ester methanesulfonate hydrate; Lercanidipine Hydrochloride Related Compound; Zanedip Mesylate Hydrate; Lercanidipine Mesylate Monohydrate; Lercanidipine Methanesulfonate Monohydrate
EINECS	Contact for details

Quality Control

Our production of this high-value intermediate adheres to strict quality management systems, ensuring batch-to-batch consistency and reliability. Quality is verified through a comprehensive suite of analytical techniques including HPLC, chiral chromatography, NMR, and mass spectrometry to confirm identity, purity, and enantiomeric excess. A detailed Certificate of Analysis (COA) is provided with each shipment, documenting compliance with agreed specifications. Our facilities and processes are designed to meet the stringent requirements of cGMP for pharmaceutical applications.

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 product is hygroscopic (moisture-sensitive) and must be kept under dry conditions to prevent degradation. For long-term storage, consider desiccated conditions.

Specification

Item	Specification
Appearance	White to off-white crystalline powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Assay (HPLC)	≥ 98.5%
Enantiomeric Purity (Chiral HPLC)	≥ 99.0%
Water Content (KF)	3.0% - 6.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Heavy Metals	< 20 ppm
Related Substances (HPLC)	Total impurities < 1.5% Any single unknown impurity < 0.5%

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