Description

Lercanidipine Impurity A is a specified impurity and degradation product of the calcium channel blocker Lercanidipine Hydrochloride. This compound is critical for pharmaceutical research and development, serving as a key reference standard for analytical method development, validation, and quality control. It is primarily utilized by pharmaceutical manufacturers, contract research organizations (CROs), and analytical laboratories to ensure the purity, safety, and efficacy of Lercanidipine-based drug products.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Lercanidipine Hydrochloride active pharmaceutical ingredient (API) and finished dosage forms.
• Analytical Method Development: Essential for developing and validating stability-indicating HPLC, UPLC, or GC methods to monitor impurity profiles.
• Quality Control & Assurance: Employed in routine QC testing to ensure batch-to-batch consistency and compliance with ICH Q3A/B guidelines on impurities.
• Stability Studies: Used to identify and track degradation products formed under various stress conditions (e.g., heat, light, humidity) as per ICH stability protocols.
• Regulatory Submissions: Provides necessary impurity characterization data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Process Chemistry Research: Aids in understanding and optimizing synthetic pathways to minimize the formation of this specific impurity.

Basic Information

Product Name	Lercanidipine Impurity A
CAS No.	74936-74-6
Molecular Formula	C36H41N3O6
Molecular Weight	611.73 g/mol
Synonyms	1,4-Dihydro-2,6-dimethyl-4-(3-nitrophenyl)-3,5-pyridinedicarboxylic acid 2-[(3,3-diphenylpropyl)methylamino]ethyl 1-methylethyl ester; Lercanidipine Related Compound A; Lercanidipine EP Impurity A; Lercanidipine USP Impurity A; (RS)-2-[(3,3-Diphenylpropyl)methylamino]-1,1-dimethylethyl methyl 1,4-dihydro-2,6-dimethyl-4-(3-nitrophenyl)pyridine-3,5-dicarboxylate; Lercanidipine Nitro Impurity; Lercanidipine Degradation Product A
EINECS	Contact for details

Quality Control

Our Lercanidipine Impurity A is manufactured under strict quality systems and undergoes rigorous analytical testing to ensure high purity and batch-to-batch consistency. Each batch is supplied with a comprehensive Certificate of Analysis (COA) detailing results for identity, purity, and impurity profiles. Our quality standards align with ICH guidelines, and the material is suitable for use as a reference standard in pharmaceutical applications.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	≥ 95.0%
Purity (HPLC, Area %)	≥ 98.0%
Single Unknown Impurity	≤ 1.0%
Total Impurities	≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C

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