Description

Lercanidipine Impurity 6 is a designated impurity of the antihypertensive drug Lercanidipine Hydrochloride, identified by the CAS registry number 786625-22-7. This compound is critical for pharmaceutical research and development, serving as a key reference standard for analytical method development, validation, and quality control processes. It is essential for manufacturers and analytical laboratories focused on ensuring the purity, safety, and regulatory compliance of Lercanidipine API and its finished dosage forms.

Application

This high-purity chemical reference standard is primarily utilized in the following scenarios:

• Pharmaceutical Impurity Profiling and Identification: Used as a certified reference material to identify and quantify Lercanidipine Impurity 6 in active pharmaceutical ingredients (APIs) and drug products.
• Analytical Method Development and Validation: Serves as a critical standard for developing, optimizing, and validating HPLC, UPLC, and GC methods for purity assays.
• Quality Control and Stability Studies: Employed in routine QC testing and forced degradation studies to monitor impurity levels and ensure product stability over time.
• Regulatory Compliance and Documentation: Provides essential data for regulatory filings (e.g., ANDA, NDA) with agencies like the US FDA, EMA, and others, supporting impurity qualification.
• Research and Development: Used in synthetic chemistry research to study the formation pathways and chemical behavior of this specific impurity.

Basic Information

Product Name	Lercanidipine Impurity 6
CAS No.	786625-22-7
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 6; Lercanidipine EP Impurity G; Lercanidipine Nitro Impurity; (RS)-2-[(3,3-Diphenylpropyl)methylamino]ethyl 1-methylethyl 1,4-dihydro-2,6-dimethyl-4-(3-nitrophenyl)-3,5-pyridinedicarboxylate; Lercanidipine Nitro Derivative
EINECS	Contact for details

Quality Control

Our Lercanidipine Impurity 6 is manufactured under strict quality systems. Each batch undergoes rigorous analytical testing to ensure high purity and accurate identification, aligning with ICH Q3A/B guidelines for impurities. A comprehensive Certificate of Analysis (COA) is provided, detailing results from HPLC purity assay, related substance analysis, and structural confirmation tests (IR, MS, NMR). We support compliance with pharmacopeial standards (USP, EP) and cGMP principles where applicable.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or Certificate of Analysis. The container should be kept in a dry, cool, and well-ventilated area. For long-term storage, consider conditions under an inert atmosphere to ensure stability.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any individual unknown impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 1.0% w/w

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