Description

Nimodipine Related Compound B (50 Mg) (Bis(2-Methoxyethyl) 2,6-Dimethyl-4-(3-Nitrophenyl)-1,4-Dihydropyridine-3,5-Dicarboxylate) is a high-purity reference standard and key impurity used in the analytical profiling of the pharmaceutical agent Nimodipine. This compound is critical for ensuring the quality, safety, and efficacy of Nimodipine formulations by serving as a benchmark in chromatographic and spectroscopic analyses. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and quality control processes.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the quantitative and qualitative analysis of Nimodipine active pharmaceutical ingredient (API) and finished dosage forms.
• Impurity Profiling and Control: Essential for identifying, quantifying, and monitoring Nimodipine Related Compound B as a specified impurity in compliance with ICH Q3A(R2) and Q3B(R2) guidelines.
• Analytical Method Development & Validation: Serves as a critical component in developing and validating HPLC, UPLC, and GC methods for stability-indicating assays.
• Quality Control & Assurance (QC/QA): Employed in routine batch release testing to ensure Nimodipine products meet stringent pharmacopeial specifications (USP, EP, BP).
• Stability Studies: Used as a marker to assess the degradation pathways and shelf-life of Nimodipine under various stress conditions.
• Regulatory Submissions: Provides necessary data for Drug Master Files (DMFs), Common Technical Documents (CTDs), and other regulatory filings to agencies like the FDA and EMA.
• Research & Development: Utilized in synthetic chemistry research to study the metabolism and degradation products of dihydropyridine calcium channel blockers.

Basic Information

Product Name	Nimodipine Related Compound B (50 Mg)
CAS No.	70172-96-2
Molecular Formula	C24H30N2O8
Molecular Weight	474.51 g/mol
Synonyms	Bis(2-Methoxyethyl) 2,6-Dimethyl-4-(3-Nitrophenyl)-1,4-Dihydropyridine-3,5-Dicarboxylate; Nimodipine Impurity B; Nimodipine Related Substance B; 1,4-Dihydro-2,6-dimethyl-4-(3-nitrophenyl)-3,5-pyridinedicarboxylic Acid Bis(2-methoxyethyl) Ester; 4-(3-Nitrophenyl)-2,6-dimethyl-1,4-dihydropyridine-3,5-dicarboxylic Acid Di(2-methoxyethyl) Ester; Nimodipine Degradation Product; Nimodipine Process Impurity.
EINECS	Contact for details

Quality Control

Every batch of Nimodipine Related Compound B is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing using advanced analytical techniques to ensure compliance with pharmacopeial standards and customer specifications. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing results for appearance, identification (HPLC, IR), assay (HPLC), and related substances. We support compliance with ICH, USP, and EP guidelines for impurity qualification.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, 15-25°C (59-77°F). The product is light-sensitive and should be handled under appropriate conditions to prevent degradation.

Specification

Item	Specification
Appearance	Yellow to orange crystalline powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Assay (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 0.5%

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