Description

Nimodipine Impurity 15 is a designated reference standard used in the analytical profiling and quality control of Nimodipine, a calcium channel blocker medication. This compound is critical for pharmaceutical manufacturers and analytical laboratories to ensure product purity, safety, and regulatory compliance. It is primarily utilized in research and development, method validation, and as a critical component in impurity identification studies for Nimodipine active pharmaceutical ingredients (APIs) and finished dosage forms.

Application

• Pharmaceutical Reference Standard: Serves as a certified external standard for the quantification and identification of related substances in Nimodipine API and drug products.
• Analytical Method Development & Validation: Essential for developing, optimizing, and validating chromatographic methods (HPLC, UPLC) to separate and detect impurities.
• Quality Control & Batch Release: Used in routine QC testing to monitor impurity levels against established specifications, ensuring batch-to-batch consistency.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., FDA, EMA) by providing characterized impurity data for drug master files (DMFs) and investigational new drug (IND) applications.
• Stability Studies: Employed to track the formation of degradation products in Nimodipine formulations under various stress conditions (e.g., heat, light, humidity).
• Research on Degradation Pathways: Aids in understanding the chemical stability and degradation mechanisms of Nimodipine.

Basic Information

Product Name	Nimodipine Impurity 15
CAS No.	24871-74-7
Molecular Formula	C21H26N2O7
Molecular Weight	418.45 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 Related Compound; Nimodipine Impurity; 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 products undergo rigorous quality testing to ensure compliance with industry standards. Each batch of Nimodipine Impurity 15 is characterized using advanced analytical techniques to confirm identity, purity, and strength. Certificates of Analysis (COA) are provided, detailing results from tests such as HPLC purity, NMR, and mass spectrometry. We adhere to quality management principles suitable for use in regulated pharmaceutical development.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). Due to its hygroscopic (moisture-sensitive) nature, the container must be kept tightly sealed in a dry environment to prevent degradation. For long-term storage, consider desiccants.

Specification

Item	Specification
Appearance	Yellow to light brown powder
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unspecified impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 5.0%

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