Description

Lercanidipine-D Impurity 2 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-D by serving as a key marker in impurity profiling and method validation. It is an essential material for pharmaceutical R&D laboratories, quality control units, and regulatory affairs departments engaged in the development and manufacturing of cardiovascular medications.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of impurities in Lercanidipine-D API and finished dosage forms.
• Analytical Method Development & Validation: Critical for developing, optimizing, and validating HPLC, UPLC, or LC-MS methods to monitor process-related impurities.
• Quality Control & Assurance: Used in routine batch release testing to ensure API and drug products meet stringent pharmacopeial (e.g., USP, EP) and ICH Q3A/B guidelines for impurity limits.
• Stability Studies: Employed as a marker to track impurity formation and degradation pathways in forced degradation and long-term stability studies of Lercanidipine-D.
• Regulatory Submissions: Provides necessary data for Drug Master Files (DMFs), Common Technical Documents (CTDs), and other regulatory filings to demonstrate comprehensive impurity control.
• Process Chemistry R&D: Aids chemists in understanding and optimizing synthesis pathways to minimize the formation of this specific impurity.

Basic Information

Product Name	Lercanidipine-D Impurity 2
CAS No.	2250243-16-2
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Lercanidipine Impurity D2; Lercanidipine Related Compound 2; Lercanidipine-D Process Impurity; Lercanidipine Specified Impurity; (RS)-2-[(3,3-Diphenylpropyl)methylamino]-1,1-dimethylethyl methyl 2,6-dimethyl-4-(3-nitrophenyl)-1,4-dihydropyridine-3,5-dicarboxylate impurity; Lercanidipine HCl Impurity 2; Lercanidipine-D Degradant
EINECS	Contact for details

Quality Control

Our Lercanidipine-D Impurity 2 is manufactured under strict quality systems to ensure it meets the exacting standards required for pharmaceutical reference materials. Each batch is characterized and qualified using advanced analytical techniques including NMR, MS, and HPLC. A comprehensive Certificate of Analysis (COA) is provided, detailing purity, identity, and impurity profile, ensuring full traceability and compliance with current Good Manufacturing Practice (cGMP) principles and ICH guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C, in a dry environment. Handle the material under appropriate conditions to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms
Identification (IR)	Conforms to reference spectrum
Purity (HPLC)	≥ 98.0%
Single Unknown Impurity (HPLC)	≤ 1.0%
Total Impurities (HPLC)	≤ 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.