Description

Oxidized Nifedipine is a key pharmaceutical intermediate and reference standard derived from the calcium channel blocker nifedipine. This compound is critical for analytical research, method development, and quality control processes in pharmaceutical manufacturing. It is primarily utilized by research institutions, analytical laboratories, and API producers involved in cardiovascular drug development and impurity profiling.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the HPLC/LC-MS analysis of nifedipine and related drug products.
• Analytical Research: Serves as a critical material for method development, validation, and degradation studies in pharmaceutical R&D.
• Active Pharmaceutical Ingredient (API) Impurity Profiling: Essential for identifying and quantifying oxidative degradation products in nifedipine bulk drug substances to ensure purity and stability.
• Metabolite Studies: Employed in pharmacological and toxicological research to study the metabolic pathways of nifedipine.
• Quality Control Laboratories: Used for system suitability testing and as a control in the quality assurance of finished pharmaceutical formulations.

Basic Information

Product Name	Oxidized Nifedipine
CAS No.	67035-22-7
Molecular Formula	C17H18N2O7
Molecular Weight	362.34 g/mol
Synonyms	Nifedipine Impurity C (Oxidized); Nifedipine Oxidation Product; 1,4-Dihydro-2,6-dimethyl-4-(2-nitrophenyl)-3,5-pyridinedicarboxylic Acid Dimethyl Ester N-Oxide; 2,6-Dimethyl-4-(2-nitrophenyl)-1,4-dihydropyridine-3,5-dicarboxylate Dimethyl Ester N-Oxide; Nifedipine N-Oxide; Nifedipine Related Compound C
EINECS	Contact for details

Quality Control

Our Oxidized Nifedipine is produced and handled under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC purity assay and identity confirmation (IR, MS), to ensure it meets the stringent requirements for use as a reference material. A detailed Certificate of Analysis (COA) with batch-specific data is provided with every shipment.

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 strictly light-sensitive and hygroscopic; containers must be kept sealed in a dark environment to prevent degradation and moisture absorption.

Specification

Item	Specification
Appearance	Yellow to light brown powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 98.0%
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.