Description

Lercanidipine-D Impurity 1 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and efficacy of the active pharmaceutical ingredient Lercanidipine, a calcium channel blocker used in antihypertensive medications. It is an essential material for pharmaceutical R&D laboratories, quality control units, and regulatory affairs departments engaged in method development, validation, and impurity profiling studies to meet stringent pharmacopeial standards.

Application

• Pharmaceutical Impurity Profiling and Characterization: Serves as a certified reference material for identifying and quantifying this specific impurity in Lercanidipine drug substances and finished products.
• Analytical Method Development and Validation: Used as a critical standard to develop, optimize, and validate HPLC, UPLC, or LC-MS methods for accurate impurity detection.
• Quality Control and Assurance (QC/QA): Employed in routine batch testing within pharmaceutical manufacturing to ensure product purity complies with ICH Q3A/B guidelines and regulatory filings.
• Stability Studies: Used to monitor the formation and level of this impurity during forced degradation and long-term stability testing of drug products.
• Regulatory Submission and Compliance: Provides essential data for regulatory documentation (e.g., FDA, EMA) to establish impurity thresholds and justify specifications.
• Research and Development: Facilitates synthetic route optimization and process chemistry studies by helping to understand and control impurity formation.

Basic Information

Product Name	Lercanidipine-D Impurity 1
CAS No.	2250242-51-2
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Lercanidipine Impurity D1; Lercanidipine Related Compound 1; Lercanidipine Specified Impurity 1; Lercanidipine-D1; (RS)-2-[(3,3-Diphenylpropyl)methylamino]-1,1-dimethylethyl methyl 2,6-dimethyl-4-(3-nitrophenyl)-1,4-dihydropyridine-3,5-dicarboxylate impurity; 1,4-Dihydropyridine-3,5-dicarboxylic acid, 2,6-dimethyl-4-(3-nitrophenyl)-, 2-[(3,3-diphenylpropyl)methylamino]-1,1-dimethylethyl methyl ester
EINECS	Contact for details

Quality Control

Our Lercanidipine-D Impurity 1 is manufactured under strict quality systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity, NMR and MS for structural confirmation, and residual solvent analysis. We provide full traceability and a detailed Certificate of Analysis (COA) that includes batch number, expiration date, and results for all critical quality attributes, ensuring compliance with ICH guidelines and customer-specific requirements.

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 maintain stability.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time matches reference standard
Identification (MS)	Consistent with molecular structure
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unspecified impurity ≤ 2.0% Total impurities ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 1.0%

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