Description

Nimodipine Impurity 12 is a designated impurity reference standard used in the analytical profiling and quality control of Nimodipine, a calcium channel blocker pharmaceutical. This high-purity compound is critical for ensuring the safety, efficacy, and regulatory compliance of Nimodipine drug substances and finished products. It is an essential material for pharmaceutical R&D laboratories, quality control (QC) units, and contract research organizations (CROs) involved in method development, validation, and stability studies.

Application

• Pharmaceutical Reference Standard: Primary use as a certified impurity standard for qualitative and quantitative analysis in Nimodipine drug substance and product testing.
• Method Development & Validation: Critical for developing and validating sensitive analytical methods, such as HPLC and UPLC, to detect and quantify this specific impurity.
• Stability Studies: Used to monitor the formation of Nimodipine Impurity 12 over time under various stress conditions (e.g., heat, light, humidity) to establish product shelf-life.
• Quality Control & Batch Release: Employed in routine QC testing to ensure Nimodipine batches meet stringent pharmacopeial (e.g., USP, EP) or internal purity specifications.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., ANDA, NDA) to demonstrate comprehensive impurity profiling and control strategies.
• Research on Degradation Pathways: Serves as a tool in research to understand the chemical degradation pathways of Nimodipine.

Basic Information

Product Name	Nimodipine Impurity 12
CAS No.	39562-18-0
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; 3,5-Pyridinedicarboxylic acid, 1,4-dihydro-2,6-dimethyl-4-(3-nitrophenyl)-, 2-(2-methoxyethyl) 1-methylethyl ester
EINECS	Contact for details

Quality Control

Our Nimodipine Impurity 12 is manufactured under strict quality systems. Each batch undergoes rigorous identity confirmation, purity assay, and impurity profiling using advanced analytical techniques including HPLC, GC, and NMR to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with every shipment to support your regulatory and quality requirements.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This product is hygroscopic (moisture-sensitive) and must be kept in a desiccated environment to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5%
Water Content (KF)	≤ 1.0% w/w
Residue on Ignition	≤ 0.1%

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