Description

Nimodipine Impurity 4 is a designated impurity of the calcium channel blocker Nimodipine, identified by CAS No. 74936-69-9. This compound is critical for pharmaceutical research and development, serving as a key reference standard for ensuring the purity, safety, and efficacy of Nimodipine drug substances and products. It is primarily needed by analytical laboratories, quality control units, and regulatory affairs departments within the pharmaceutical and biotechnology industries for method development, validation, and compliance testing.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Nimodipine Impurity 4 in active pharmaceutical ingredients (APIs) and finished dosage forms.
• Analytical Method Development & Validation: Essential for developing and validating stability-indicating HPLC, UPLC, or LC-MS methods to monitor impurities during drug stability studies.
• Quality Control & Batch Release: Employed in routine QC testing to ensure Nimodipine batches meet stringent pharmacopeial (e.g., USP, EP) or internal specification limits for related substances.
• Regulatory Compliance & Filings: Supports the preparation of regulatory submission documents (e.g., CMC sections for FDA, EMA) by providing characterized impurity profiles.
• Stability Studies: Acts as a marker to track the formation of this specific degradation product under various stress conditions (light, heat, humidity).
• Process Chemistry Research: Used by chemists to study and optimize synthetic pathways to minimize the formation of this impurity during Nimodipine manufacturing.

Basic Information

Product Name	Nimodipine Impurity 4
CAS No.	74936-69-9
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-pyridinedicarboxylate; Nimodipine Related Compound; Nimodipine EP Impurity D; Nimodipine USP Related Compound; 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 management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity confirmation and structural elucidation via spectroscopic methods (NMR, MS), to ensure it meets the high standards required for pharmaceutical impurity analysis. Certificates of Analysis (COA) with detailed chromatographic data are provided to support your regulatory and quality assurance needs.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation.

Specification

Item	Specification
Appearance	Yellow to light brown powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unspecified impurity ≤ 2.0% Total impurities ≤ 5.0%
Water Content (KF)	≤ 5.0%
Residue on Ignition	≤ 0.5%

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