Description

Nimodipine Impurity 6 CAS NO 39562-21-5 is a specified impurity of the calcium channel blocker Nimodipine, used in pharmaceutical research and development. This compound is critical for ensuring the quality, safety, and efficacy of Nimodipine drug substances and products through rigorous analytical control. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and stability studies.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the qualitative and quantitative analysis of Nimodipine in drug substances and finished products.
• Method Development and Validation: Essential for developing and validating chromatographic methods (HPLC, UPLC) to monitor and control this specific impurity.
• Quality Control (QC) Testing: Serves as a system suitability standard in routine QC testing to ensure the purity and consistency of Nimodipine batches.
• Stability Studies: Employed to identify and quantify degradation products formed under various stress conditions (e.g., heat, light, humidity) during stability testing.
• Regulatory Compliance and Filing: A critical component in regulatory submissions (e.g., for FDA, EMA) to establish impurity profiles and justify specification limits.
• Research and Development: Used in R&D to study the degradation pathways and chemical behavior of Nimodipine, aiding in formulation optimization.

Basic Information

Product Name	Nimodipine Impurity 6
CAS No.	39562-21-5
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 Analog
EINECS	Contact for details

Quality Control

Our Nimodipine Impurity 6 is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity and identity confirmation (IR, NMR), to ensure it meets the high standards required for pharmaceutical impurity analysis. A detailed Certificate of Analysis (COA) is provided with each shipment, confirming batch-specific data and compliance with relevant guidelines.

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 should be handled in a dry environment to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual impurity ≤ 1.0%
Water Content (KF)	≤ 0.5%
Residue on Ignition	≤ 0.1%

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