Description

Nifedipine Pyrimidine Impurity is a key chemical reference standard used in the pharmaceutical development and quality control of the antihypertensive drug Nifedipine. This impurity is critical for ensuring the safety, efficacy, and regulatory compliance of the final drug product by enabling accurate identification and quantification of related substances. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and research institutions engaged in method validation, stability studies, and the synthesis of high-purity active pharmaceutical ingredients (APIs).

Application

• Pharmaceutical Impurity Reference Standard for the quality control of Nifedipine API and finished dosage forms.
• Method Development and Validation in analytical laboratories using HPLC, LC-MS, or GC-MS techniques.
• Stability Indicating Studies to monitor the formation of degradation products in Nifedipine formulations.
• Regulatory Compliance and Documentation for submissions to agencies like the FDA, EMA, and ICH.
• Research and Development of synthetic pathways and purification processes for Nifedipine.
• Calibration of Analytical Instruments to ensure accurate detection and measurement thresholds.

Basic Information

Product Name	Nifedipine Pyrimidine Impurity
CAS No.	80742-11-6
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Nifedipine Related Compound; Nifedipine Impurity; Dimethyl 2,6-dimethyl-4-(2-nitrophenyl)-1,4-dihydropyridine-3,5-dicarboxylate pyrimidine analog; 1,4-Dihydropyridine derivative; Nifedipine Degradation Product; Nifedipine Process Impurity; Nitrendipine related impurity; Contact for further synonyms.
EINECS	Contact for details

Quality Control

Our Nifedipine Pyrimidine Impurity is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing to ensure high purity and identity confirmation, aligning with ICH guidelines for impurity standards. A comprehensive Certificate of Analysis (COA) is provided, detailing results for assay, purity, and identification tests. We support compliance with USP, EP, and other pharmacopeial standards upon request.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (typically 15-25°C). Due to its hygroscopic (moisture-sensitive) nature, the container should be kept in a desiccated environment to prevent degradation. Handle with appropriate personal protective equipment in a well-ventilated area.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Conforms to reference
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Water Content (KF)	≤ 5.0%
Residue on Ignition	≤ 0.1%

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