Description

Nimodipine Impurity 3 is a designated pharmaceutical reference standard used for the analytical profiling and quality control of Nimodipine, a calcium channel blocker medication. This impurity is critical for ensuring the purity, safety, and efficacy of Nimodipine active pharmaceutical ingredients (APIs) and finished drug products. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in research, development, and quality assurance processes.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for method development, validation, and routine quality control testing of Nimodipine API.
• Analytical Method Development: Used in HPLC, UPLC, and LC-MS studies to identify, quantify, and characterize this specific impurity in Nimodipine batches.
• Regulatory Compliance & Documentation: Essential for preparing regulatory submission documents (e.g., for FDA, EMA) to demonstrate comprehensive impurity profiling and control strategies.
• Stability Studies: Employed to monitor the formation of Nimodipine Impurity 3 over time under various stress conditions, supporting shelf-life determination.
• Pharmacopoeial Testing: Used in testing to comply with pharmacopoeial monographs (e.g., USP, EP, BP) that specify limits for known and unknown impurities.
• Research & Development: Aids in synthetic route optimization and process chemistry by identifying and quantifying this by-product or degradation product.

Basic Information

Product Name	Nimodipine Impurity 3
CAS No.	101072-61-1
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-pyridinedicarboxylate; Nimodipine Isomer; Nimodipine Related Compound; Nimodipine Process Impurity
EINECS	Contact for details

Quality Control

Every batch of Nimodipine Impurity 3 is manufactured and analyzed under strict quality management systems. The product undergoes rigorous identity confirmation, purity analysis, and impurity profiling using advanced techniques such as HPLC, GC, NMR, and mass spectrometry to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) detailing all test results and specifications is provided with each 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 compound is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation. For long-term storage, consider desiccated conditions.

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)	Total impurities ≤ 2.0% Any individual impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 0.5%

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