Description

Nimodipine Impurity 4 is a designated impurity of the calcium channel blocker Nimodipine, a critical pharmaceutical agent. This compound is essential for analytical research and development, serving as a key reference standard for quality control and regulatory compliance in pharmaceutical manufacturing. It is primarily required by research institutions, quality control laboratories, and API producers focused on developing and validating robust analytical methods for Nimodipine.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification, qualification, and quantification of impurities in Nimodipine Active Pharmaceutical Ingredient (API) and finished dosage forms.
• Analytical Method Development & Validation: Critical for developing and validating stability-indicating HPLC, UPLC, or GC methods to monitor impurity profiles during drug development and manufacturing.
• Quality Control & Assurance (QC/QA): Employed in routine batch testing to ensure Nimodipine products meet stringent pharmacopeial standards (e.g., USP, EP, ICH guidelines) for purity and safety.
• Stability Studies: Used to track the formation and growth of this specific impurity under various stress conditions (heat, light, humidity) to establish product shelf-life.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., with FDA, EMA) to demonstrate comprehensive understanding and control of the impurity profile.
• Process Chemistry Research: Aids in optimizing synthesis and purification processes for Nimodipine by identifying and controlling the source of this impurity.

Basic Information

Product Name	Nimodipine Impurity 4
CAS No.	116799-92-9
Molecular Formula	C21H26N2O7
Molecular Weight	418.44 g/mol
Synonyms	1,4-Dihydro-2,6-dimethyl-4-(3-nitrophenyl)-3,5-pyridinedicarboxylic acid 2-methoxyethyl 1-methylethyl ester; Isopropyl 2-methoxyethyl 1,4-dihydro-2,6-dimethyl-4-(3-nitrophenyl)-3,5-pyridinedicarboxylic acid ester; Nimodipine Impurity D; Nimodipine Related Compound D; 3,5-Pyridinedicarboxylic acid, 1,4-dihydro-2,6-dimethyl-4-(3-nitrophenyl)-, 2-methoxyethyl 1-methylethyl ester
EINECS	Contact for details

Quality Control

Our Nimodipine Impurity 4 is manufactured under strict quality systems. Each batch is characterized and undergoes rigorous analytical testing, including HPLC for purity and identity confirmation (IR, MS), to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with every shipment.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or COA. 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 corresponds to reference
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity ≤ 1.0% Total impurities ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C

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