Description

Cilnidipine Impurity 3 CAS NO 123853-41-8 is a high-purity chemical reference standard used for the identification, qualification, and quantification of a specific process-related impurity in the antihypertensive drug Cilnidipine. This compound is critical for pharmaceutical quality control and regulatory compliance, ensuring the safety and efficacy of the final drug product. It is primarily required by analytical laboratories, research institutions, and pharmaceutical manufacturers engaged in method development, stability studies, and batch release testing.

Application

• Pharmaceutical Reference Standard: Primary use as a certified impurity standard for HPLC, LC-MS, and other analytical methods.
• Method Development and Validation: Essential for developing and validating impurity profiling methods for Cilnidipine API (Active Pharmaceutical Ingredient).
• Quality Control & Batch Release: Used in routine QC testing to monitor and control impurity levels in commercial drug substance and drug product batches.
• Stability Studies: Employed to identify and track degradation products in forced degradation and long-term stability studies of Cilnidipine formulations.
• Regulatory Submissions: Supports regulatory filings (e.g., for FDA, EMA) by providing necessary impurity characterization data.
• Research & Development: Used in synthetic chemistry R&D to understand and optimize the Cilnidipine manufacturing process to minimize this impurity.

Basic Information

Product Name	Cilnidipine Impurity 3
CAS No.	123853-41-8
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 C; Cilnidipine Impurity C; Cilnidipine EP Impurity C; Cilnidipine USP Impurity; (E)-Cinnamyl Methyloxyethyl Cilnidipine Impurity; Cilnidipine Process Impurity
EINECS	Contact for details

Quality Control

Our Cilnidipine Impurity 3 is manufactured under controlled conditions and undergoes rigorous analytical testing to ensure identity, purity, and consistency. Each batch is supplied with a comprehensive Certificate of Analysis (COA) detailing results for assay, related substances, residual solvents, and other critical parameters. Quality standards are aligned with ICH guidelines and current pharmacopeial requirements for impurity reference standards.

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 in a desiccated environment to maintain stability and purity. Handle with appropriate precautions in a well-ventilated laboratory setting.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual unknown impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
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.