Description

Lercanidipine Impurity 25 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 ensuring the purity, safety, and efficacy of the final drug product by serving as a reference marker in chromatographic methods. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and routine batch release testing.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the identification and quantification of related substances in Lercanidipine API and its finished dosage forms.
• Analytical Method Development & Validation (HPLC/LC-MS): Used as a critical component in developing and validating stability-indicating assay methods for Lercanidipine.
• Quality Control & Batch Release Testing: Essential for routine quality control to monitor impurity levels and ensure compliance with pharmacopeial specifications (e.g., ICH Q3A/B, USP, EP).
• Stability Studies: Employed to track the formation of degradation products under various stress conditions (e.g., heat, light, humidity) during drug substance and product stability testing.
• Regulatory Submissions: Provides necessary impurity characterization data for regulatory filings (e.g., ANDA, NDA, CMC dossiers) to support drug approval.
• Research & Development: Used in R&D to understand the degradation pathways and impurity profile of Lercanidipine during synthesis and formulation processes.

Basic Information

Product Name	Lercanidipine Impurity 25
CAS No.	100427-22-3
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Lercanidipine Related Compound 25; Lercanidipine Impurity F (Potential); 1,4-Dihydro-2,6-dimethyl-4-(3-nitrophenyl)-3,5-pyridinedicarboxylic acid 2-[(3,3-diphenylpropyl)methylamino]-1,1-dimethylethyl methyl ester; Lercanidipine Nitro Impurity; Lercanidipine Nitro Analog; 3-Nitro Lercanidipine; Lercanidipine Nitro Derivative
EINECS	Contact for details

Quality Control

Our Lercanidipine Impurity 25 is manufactured and handled under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC purity analysis and spectroscopic identification (NMR, MS), to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with every shipment to support your quality and regulatory requirements.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. The product is light-sensitive and should be handled under appropriate conditions to prevent degradation.

Specification

Item	Specification
Appearance	Off-white to light yellow solid
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unspecified impurity ≤ 2.0% Total impurities ≤ 5.0%
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.