Description

Lercanidipine Impurity B is a designated impurity standard used in the analytical profiling and quality control of the antihypertensive active pharmaceutical ingredient (API) Lercanidipine Hydrochloride. This compound is critical for pharmaceutical manufacturers and analytical laboratories to ensure product purity, safety, and regulatory compliance. It serves as a key reference material for method development, validation, and routine batch testing within the pharmaceutical industry.

Application

• Primary use as a certified reference standard (CRS) for the identification and quantification of impurities in Lercanidipine Hydrochloride API.
• Essential for analytical method development and validation (HPLC, UPLC, LC-MS) in quality control laboratories.
• Used in stability studies to monitor degradation pathways and establish shelf-life for pharmaceutical formulations.
• Critical for regulatory submissions (e.g., FDA, EMA) to demonstrate comprehensive impurity profiling and control strategies.
• Supports pharmaceutical research and development for process optimization and impurity synthesis studies.
• Serves as a system suitability component in pharmacopoeial testing to ensure analytical instrument performance.

Basic Information

Product Name	Lercanidipine Impurity B
CAS No.	1119226-97-9
Molecular Formula	C36H41N3O6
Molecular Weight	611.73 g/mol
Synonyms	(2R/S,3S)-3-[(3,3-Diphenylpropyl)amino]-2,6-dimethyl-5-(1-methylethyl)-4-(3-nitrophenyl)-1,4-dihydro-3,5-pyridinedicarboxylic Acid 2-[4-[(2,3-Dichlorophenyl)-1-piperazinyl]butyl] Ester; Lercanidipine Related Compound B; Lercanidipine EP Impurity B; Lercanidipine USP Impurity B; Lercanidipine Process Impurity; 1,4-Dihydro-2,6-dimethyl-4-(3-nitrophenyl)-3,5-pyridinedicarboxylic Acid 3-[(3,3-diphenylpropyl)amino]-5-(1-methylethyl) 2-[4-[4-(2,3-dichlorophenyl)-1-piperazinyl]butyl] Ester
EINECS	Contact for details

Quality Control

Every batch of Lercanidipine Impurity B is manufactured and analyzed under strict quality management systems. Our products undergo rigorous quality testing to ensure compliance with industry standards, including potential alignment with pharmacopoeial guidelines (e.g., USP, EP). Comprehensive characterization is performed using advanced techniques such as HPLC, GC, NMR, and MS. Certificates of Analysis (COA) detailing purity, identity, and impurity profiles are available upon request.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C, in a dry environment. This material is light-sensitive (store away from light).

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any individual unspecified impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines

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