Description

Cilnidipine Impurity 2 is a designated impurity of the calcium channel blocker Cilnidipine, a key pharmaceutical active used in antihypertensive therapy. This compound is critical for pharmaceutical research and development, serving as a reference standard for quality control and analytical method validation. It is primarily required by analytical chemists, quality assurance professionals, and R&D scientists in the pharmaceutical industry to ensure drug purity, safety, and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Cilnidipine Impurity 2 in drug substances and finished products.
• Analytical Method Development & Validation: Essential for developing, optimizing, and validating HPLC, UPLC, or LC-MS methods for impurity profiling.
• Quality Control & Assurance (QC/QA): Critical for routine batch testing in pharmaceutical manufacturing to monitor impurity levels against ICH guidelines.
• 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 impurity characterization data for drug master files (DMFs), ANDAs, and other regulatory dossiers for global markets.
• Research on Degradation Pathways: Used in forced degradation studies to understand the chemical behavior and stability of Cilnidipine.

Basic Information

Product Name	Cilnidipine Impurity 2
CAS No.	146845-34-3
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 1-Benzyl-3-pyrrolidinyl Ester; Cilnidipine Related Compound; Cilnidipine EP Impurity B; Cilnidipine USP Impurity; (RS)-3-Pyrrolidinyl 1-Benzyl-1,4-dihydro-2,6-dimethyl-4-(3-nitrophenyl)pyridine-3,5-dicarboxylate; Cilnidipine Degradation Product
EINECS	Contact for details

Quality Control

Every batch of Cilnidipine Impurity 2 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity testing using advanced analytical techniques (HPLC, GC, NMR, MS) to ensure compliance with pharmacopeial standards (USP, EP) and ICH Q3A/B guidelines. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). Due to its hygroscopic nature, the container should be kept in a desiccated environment to prevent moisture absorption. For long-term storage, consider storing under an inert atmosphere.

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)	Individual unknown impurity: ≤ 0.10% Total impurities: ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 0.5%
Heavy Metals	≤ 20 ppm

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