Description

Nicardipine Related Compound 4 is a designated impurity and reference standard used in the analytical profiling of the calcium channel blocker Nicardipine. This compound is critical for ensuring the purity, safety, and efficacy of Nicardipine-based pharmaceutical products through rigorous quality control protocols. It is primarily utilized by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in research, development, and quality assurance of cardiovascular medications.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the identification and quantification of related substances in Nicardipine Hydrochloride active pharmaceutical ingredient (API) and finished dosage forms.
• Analytical Method Development & Validation: Essential for developing, calibrating, and validating High-Performance Liquid Chromatography (HPLC) and other chromatographic methods in compliance with ICH guidelines.
• Quality Control & Batch Release Testing: Used in routine QC testing to monitor impurity levels and ensure drug substance and product specifications meet pharmacopeial standards (e.g., USP, EP).
• Stability Studies: Employed to track the formation of degradation products in Nicardipine formulations under various stress conditions to establish shelf life.
• Regulatory Compliance & Documentation: Provides necessary data for regulatory filings (e.g., ANDA, NDA) to demonstrate comprehensive impurity profiling and control strategies.
• Research & Development: Aids in synthetic route optimization and impurity fate and tolerance studies during the drug development process.

Basic Information

Product Name	Nicardipine Related Compound 4
CAS No.	123973-71-7
Molecular Formula	C26H29N3O6
Molecular Weight	479.53 g/mol
Synonyms	Nicardipine Impurity 4; Nicardipine Related Substance 4; 2,6-Dimethyl-4-(3-nitrophenyl)-1,4-dihydropyridine-3,5-dicarboxylic acid 3-[2-(N-benzyl-N-methylamino)]ethyl ester 5-methyl ester; 3-[N-Benzyl-N-methylamino]ethyl 5-methyl 2,6-dimethyl-4-(3-nitrophenyl)-1,4-dihydropyridine-3,5-dicarboxylate; Nicardipine EP Impurity C; Nicardipine Process Impurity
EINECS	Contact for details

Quality Control

Every batch of Nicardipine Related Compound 4 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing to ensure compliance with industry and pharmacopeial standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing results from HPLC, NMR, and mass spectrometry analyses. We support compliance with cGMP, ICH Q3A/B, and relevant regulatory guidelines for pharmaceutical impurities.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C (59-77°F), in a dry environment. The material is light-sensitive (store away from light).

Specification

Item	Specification
Appearance	Off-white to yellow powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unspecified impurity ≤ 1.0% Total impurities ≤ 3.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 1.0%

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