Description

Nimodipine Impurity 9 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 units, and regulatory affairs departments focused on method development, validation, and impurity identification.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material for the identification and quantification of Nimodipine Impurity 9 in active pharmaceutical ingredients (API) and finished dosage forms.
• Analytical Method Development & Validation: Critical for developing, optimizing, and validating stability-indicating HPLC/UPLC methods in accordance with ICH Q2(R1) guidelines.
• Quality Control & Batch Release: Used in routine QC testing to monitor impurity levels against ICH Q3A/B thresholds, ensuring batch-to-batch consistency and compliance.
• Stability Studies: Employed as a marker in forced degradation and long-term stability studies to track impurity formation pathways and establish shelf-life.
• Regulatory Submissions: Provides essential data for Drug Master Files (DMF), Common Technical Documents (CTD), and other regulatory filings to demonstrate comprehensive impurity control.
• Research & Development: Supports process chemistry research for impurity profiling during synthesis route development and optimization of Nimodipine manufacturing.

Basic Information

Product Name	Nimodipine Impurity 9
CAS No.	87966-40-3
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; Nimodipine Process Impurity
EINECS	Contact for details

Quality Control

Every batch of Nimodipine Impurity 9 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing using validated methods (HPLC, NMR, MS) to ensure compliance with pharmacopeial standards and customer specifications. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment.

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 nature, the container should be kept in a desiccated environment to prevent moisture uptake. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	Off-white to yellow powder
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 95.0%
Assay (HPLC)	98.0% - 102.0%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

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