Description

Nimodipine Related Compound A (50 Mg) (2-Methoxyethyl 1-Methylethyl 2,6-Dimethyl-4-(3-Nitrophenyl)Pyridine-3,5-Dicarboxylate) is a high-purity reference standard critical for analytical and research applications. This compound is essential for ensuring the quality, safety, and efficacy of nimodipine, a calcium channel blocker used in pharmaceutical formulations. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and research institutions for use in method development, validation, and impurity profiling. The product is supplied as a precisely weighed 50 mg quantity to guarantee accuracy and convenience in laboratory workflows.

Application

• Pharmaceutical Impurity Profiling and Identification: Serves as a certified reference material for the identification and quantification of specific impurities in nimodipine active pharmaceutical ingredients (APIs) and finished drug products.
• Analytical Method Development and Validation: Used as a critical standard to develop, optimize, and validate chromatographic methods, such as HPLC and UPLC, ensuring regulatory compliance for nimodipine analysis.
• Quality Control (QC) and Quality Assurance (QA): Employed in routine QC testing within pharmaceutical manufacturing to monitor impurity levels and confirm batch-to-batch consistency.
• Stability Studies: Acts as a marker compound in forced degradation and shelf-life studies to understand the degradation pathways of nimodipine.
• Pharmacological and Metabolic Research: Utilized in research settings to study the metabolism, pharmacokinetics, and potential interactions of nimodipine and its related substances.
• Regulatory Submissions: Provides essential data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs) submitted to agencies like the FDA and EMA.

Basic Information

Product Name	Nimodipine Related Compound A (50 Mg) (2-Methoxyethyl 1-Methylethyl 2,6-Dimethyl-4-(3-Nitrophenyl)Pyridine-3,5-Dicarboxylate)
CAS No.	85677-93-6
Molecular Formula	C24H29NO7
Molecular Weight	443.49 g/mol
Synonyms	Nimodipine Impurity A; Nimodipine Related Substance A; 2-Methoxyethyl 1-Methylethyl 2,6-Dimethyl-4-(3-Nitrophenyl)-1,4-dihydropyridine-3,5-dicarboxylate; 2-Methoxyethyl isopropyl 2,6-dimethyl-4-(3-nitrophenyl)-1,4-dihydropyridine-3,5-dicarboxylate; Isopropyl 2-methoxyethyl 2,6-dimethyl-4-(3-nitrophenyl)-1,4-dihydropyridine-3,5-dicarboxylate; Nimodipine Process Impurity; Dihydropyridine Derivative
EINECS	Contact for details

Quality Control

This high-purity reference standard is manufactured and controlled under strict quality management systems. Each 50 mg batch is accompanied by a comprehensive Certificate of Analysis (COA) that includes data for identity, purity, and impurity content. Our quality protocols are designed to meet the stringent requirements of pharmaceutical analysis and research. Certificates of Analysis (COA) are available upon request and with every 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 product is hygroscopic (moisture-sensitive) and light-sensitive; therefore, containers must be kept tightly sealed and desiccated to maintain stability and purity.

Specification

Item	Specification
Appearance	Yellow to light yellow powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH guidelines
Water Content (KF)	≤ 0.5%

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