Description

Nimodipine Impurity 16 is a designated pharmaceutical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and efficacy of Nimodipine, a calcium channel blocker medication, by serving as a benchmark in impurity profiling and method validation. It is an essential material for pharmaceutical R&D laboratories, quality control units, and regulatory bodies involved in drug development and compliance testing.

Application

• Pharmaceutical Reference Standard: Serves as a certified external standard for the quantitative and qualitative analysis of Nimodipine and its related substances.
• Impurity Profiling & Identification: Used in HPLC, LC-MS, and other chromatographic methods to identify, characterize, and control Nimodipine Impurity 16 during drug substance and product development.
• Method Development & Validation: A critical component for developing, optimizing, and validating analytical procedures to meet ICH Q2(R1) and other regulatory guidelines.
• Quality Control & Batch Release: Employed in routine QC testing of Nimodipine Active Pharmaceutical Ingredients (APIs) and finished dosage forms to ensure impurity levels are within specified limits.
• Stability Studies: Used to monitor the formation of this specific impurity under various stress conditions (e.g., heat, light, humidity) to establish product shelf-life.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., ANDA, NDA, CTA) to demonstrate comprehensive impurity control strategies to agencies like the FDA and EMA.

Basic Information

Product Name	Nimodipine Impurity 16
CAS No.	203740-59-4
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 Nitroso Impurity; Nimodipine Related Compound 16; Nimodipine Nitroso Analog; 3,5-Pyridinedicarboxylic acid, 1,4-dihydro-2,6-dimethyl-4-(3-nitrophenyl)-, 2-methoxyethyl 1-methylethyl ester
EINECS	Contact for details

Quality Control

Every batch of Nimodipine Impurity 16 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity testing using validated methods (e.g., HPLC, NMR, MS) to ensure compliance with pharmacopeial standards and customer specifications. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results for purity, related substances, and other critical quality attributes.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C, in a dry environment. For long-term storage, consider storing desiccated at 2-8°C.

Specification

Item	Specification
Appearance	Off-white to yellow solid
Identification (HPLC)	Conforms
Identification (IR)	Conforms to reference spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any individual impurity ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 1.0% w/w

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