Description

Nifedipine Ep Impurity-C CAS NO 111304-29-1 is a high-purity chemical reference standard, specifically identified as a known impurity of the active pharmaceutical ingredient Nifedipine. This compound is critical for pharmaceutical research, development, and quality control processes, enabling precise analytical method validation and ensuring drug safety and efficacy. It is an essential material for analytical chemists, quality assurance laboratories, and regulatory affairs professionals within the global pharmaceutical and contract research organization (CRO) sectors.

Application

• Pharmaceutical Impurity Profiling and Identification: Used as a certified reference material (CRM) to identify and quantify Nifedipine Ep Impurity-C in drug substance and finished product analysis.
• Analytical Method Development and Validation (HPLC/LC-MS): Serves as a critical standard for developing, optimizing, and validating chromatographic methods in compliance with ICH Q2(R1) guidelines.
• Stability Studies and Forced Degradation Testing: Employed to monitor the formation of this specific impurity under various stress conditions (e.g., heat, light, humidity) to establish product shelf-life.
• Quality Control and Batch Release Testing: Essential for setting specification limits and conducting routine quality control testing of Nifedipine API and formulations to meet pharmacopoeial standards (USP, EP).
• Regulatory Submissions and Compliance: Provides necessary data for regulatory filings (e.g., ANDA, NDA) to demonstrate thorough impurity characterization and control strategies for health authorities like the FDA and EMA.
• Research into Drug Degradation Pathways: Aids in research to understand the chemical degradation mechanisms of Nifedipine, supporting the development of more stable formulations.

Basic Information

Product Name	Nifedipine Ep Impurity-C
CAS No.	111304-29-1
Molecular Formula	C17H18N2O6
Molecular Weight	346.34 g/mol
Synonyms	1,4-Dihydro-2,6-dimethyl-4-(2-nitrophenyl)-3,5-pyridinedicarboxylic Acid Methyl (4-Nitrobenzyl) Ester; Methyl 4-Nitrobenzyl 1,4-Dihydro-2,6-dimethyl-4-(2-nitrophenyl)-3,5-pyridinedicarboxylate; Nifedipine Impurity C; Nifedipine Related Compound C; Nifedipine EP Impurity C; Nifedipine Nitroso Pyridine Analog; Nifedipine Degradation Product
EINECS	Contact for details

Quality Control

Our Nifedipine Ep Impurity-C is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity and identity confirmation (IR, MS), to ensure it meets the high standards required for pharmaceutical reference materials. We provide comprehensive Certificates of Analysis (COA) with detailed chromatographic data, ensuring full traceability and compliance with relevant pharmacopoeial guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. For long-term storage, consider storing at 2-8°C. Keep the container tightly sealed to protect from moisture.

Specification

Item	Specification
Appearance	Yellow to light yellow powder
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual unknown impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 0.5% w/w

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