Description

Nitrendipine Impurity 7 is a specified impurity of the calcium channel blocker Nitrendipine, used in pharmaceutical research and development. This compound is critical for analytical method development, stability studies, and ensuring the quality and safety of the active pharmaceutical ingredient (API). It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for quality control and compliance purposes.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Nitrendipine Impurity 7 in Nitrendipine API and finished dosage forms.
• Analytical Method Development & Validation: Essential for developing and validating HPLC, UPLC, or GC methods to monitor impurities in Nitrendipine batches.
• Stability Studies: Employed to study the degradation profile of Nitrendipine under various stress conditions (e.g., heat, light, humidity).
• Quality Control & Assurance (QC/QA): Serves as a critical tool for in-house quality control testing to ensure API purity meets pharmacopeial standards (e.g., USP, EP).
• Regulatory Compliance & Filings: Required for preparing regulatory submission documents (e.g., ANDA, DMF) to demonstrate thorough impurity profiling.
• Research & Development: Used in R&D to understand the synthesis pathway, degradation mechanisms, and toxicological profile of Nitrendipine-related substances.

Basic Information

Item	Detail
Product Name	Nitrendipine Impurity 7
CAS No.	39562-75-9
Molecular Formula	C18H20N2O6
Molecular Weight	360.36 g/mol
Synonyms	Ethyl 3,5-Pyridinedicarboxylic acid, 1,4-dihydro-2,6-dimethyl-4-(3-nitrophenyl)-, 3-ethyl 5-methyl ester; 1,4-Dihydro-2,6-dimethyl-4-(3-nitrophenyl)-3,5-pyridinedicarboxylic acid 3-ethyl 5-methyl ester; Nitrendipine Related Compound; Nitrendipine EP Impurity; Nitrendipine USP Impurity; Nitrendipine Degradant
EINECS	Contact for details

Quality Control

Our Nitrendipine Impurity 7 is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity confirmation and identity verification by spectroscopic methods (IR, NMR, MS). We provide comprehensive Certificates of Analysis (COA) with detailed chromatographic data, ensuring compliance with pharmaceutical reference standard requirements for research and regulatory purposes.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. Due to its hygroscopic nature, the container should be kept tightly sealed to minimize exposure to atmospheric moisture.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Single unspecified impurity ≤ 1.0% Total impurities ≤ 2.0%
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.