Description

Lercanidipine Impurity 4 is a designated impurity reference standard used in the analytical profiling and quality control of the antihypertensive active pharmaceutical ingredient (API), Lercanidipine Hydrochloride. This high-purity compound is critical for ensuring the safety, efficacy, and regulatory compliance of pharmaceutical formulations. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and routine batch testing.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the identification and quantification of Lercanidipine Impurity 4 in API and finished drug products.
• Analytical Method Development & Validation (HPLC/LC-MS): Essential for developing and validating stability-indicating chromatographic methods to monitor impurity profiles.
• Quality Control & Batch Release Testing: Used in routine QC laboratories to confirm that Lercanidipine batches meet stringent pharmacopeial (e.g., USP, EP) impurity limits.
• Stability Studies: Employed to track the formation of this specific degradation product under various stress conditions (e.g., heat, light, humidity).
• Regulatory Submissions: Provides necessary data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Research & Development: Supports impurity characterization, isolation studies, and synthetic pathway optimization during API process development.

Basic Information

Product Name	Lercanidipine Impurity 4
CAS No.	2727061-30-3
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Lercanidipine Related Compound 4; Lercanidipine Impurity D; Lercanidipine EP Impurity D; Lercanidipine USP Impurity 4; (RS)-2-[(3,3-Diphenylpropyl)methylamino]-1,1-dimethylethyl methyl 2,6-dimethyl-4-(3-nitrophenyl)-1,4-dihydropyridine-3,5-dicarboxylate impurity; Lercanidipine Nitro Impurity; Degradation product of Lercanidipine
EINECS	Contact for details

Quality Control

Our products undergo rigorous quality testing to ensure compliance with industry standards. Each batch of Lercanidipine Impurity 4 is characterized and qualified using advanced analytical techniques including HPLC, GC, MS, and NMR. We provide comprehensive Certificates of Analysis (COA) that detail purity, identity, and impurity profiles, supporting compliance with cGMP and ICH Q3A/B guidelines for pharmaceutical impurities.

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 and store in accordance with good laboratory practices for light-sensitive chemical reference materials.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time matches reference standard
Identification (IR)	Spectrum conforms to reference spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 1.0% Total impurities: ≤ 5.0%
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.