Description

Cilnidipine Impurity 4 CAS NO 146845-35-4 is a high-purity reference standard used in the analytical profiling and quality control of the antihypertensive active pharmaceutical ingredient (API), Cilnidipine. This compound is critical for pharmaceutical manufacturers and research laboratories to ensure product safety, efficacy, and regulatory compliance by accurately identifying and quantifying process-related impurities. It is an essential material for method development, validation, and stability studies within the pharmaceutical industry.

Application

• Pharmaceutical Reference Standard: Primary use as a certified impurity standard for the quality control of Cilnidipine API and finished dosage forms.
• Analytical Method Development: Used to develop and validate HPLC, UPLC, and GC methods for impurity profiling and assay determination.
• Regulatory Compliance & Documentation: Essential for preparing regulatory submission documents (e.g., for FDA, EMA) by providing impurity identification and characterization data.
• Stability Studies: Employed as a marker to monitor the formation of degradation products in Cilnidipine under various stress conditions.
• Process Chemistry Research: Aids in the optimization of Cilnidipine synthesis by identifying and tracking specific process-related impurities.
• Pharmacopoeial Testing: Supports testing in compliance with pharmacopoeial monographs (e.g., USP, EP, JP) that specify impurity limits.

Basic Information

Product Name	Cilnidipine Impurity 4
CAS No.	146845-35-4
Molecular Formula	C27H28N2O7
Molecular Weight	492.52 g/mol
Synonyms	1,4-Dihydro-2,6-dimethyl-4-(3-nitrophenyl)-3,5-pyridinedicarboxylic acid 2-methoxyethyl (2E)-3-phenyl-2-propen-1-yl ester; Cilnidipine Related Compound; Cilnidipine EP Impurity D; Cilnidipine USP Impurity; Cilnidipine Process Impurity; FRC-8653 Impurity; (E)-Cinnamyl Cilnidipine Ester
EINECS	Contact for details

Quality Control

Every batch of Cilnidipine Impurity 4 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous quality testing, including advanced chromatographic and spectroscopic techniques, to ensure compliance with pharmacopoeial standards and customer-specific requirements. A comprehensive Certificate of Analysis (COA) detailing purity, identity, and impurity profile is provided with each shipment.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and must be kept under inert conditions or in a desiccator to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Any individual impurity ≤ 0.5% Total impurities ≤ 1.0%
Water Content (KF)	≤ 0.5%
Residue on Ignition	≤ 0.1%

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