Description

Nifedipine Impurity J CAS NO 114709-68-1 is a high-purity chemical reference standard used for the analytical profiling and quality control of the active pharmaceutical ingredient Nifedipine. This compound is critical for pharmaceutical manufacturers and research laboratories to ensure product safety, efficacy, and regulatory compliance by accurately identifying and quantifying process-related impurities. It is an essential tool for method development, validation, and stability studies in the pharmaceutical industry.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material for the identification and quantification of Nifedipine Impurity J in drug substances and finished products.
• Analytical Method Development & Validation: Critical for developing and validating HPLC, UPLC, or GC methods to monitor impurities in Nifedipine API batches.
• Quality Control & Assurance (QC/QA): Used in routine quality control testing to ensure Nifedipine API meets pharmacopeial specifications (e.g., USP, EP, ICH Q3A/B).
• Stability Studies: Employed to track the formation of degradation impurities in Nifedipine formulations under various stress conditions.
• Regulatory Submissions: Provides necessary impurity characterization data for Drug Master Files (DMFs), New Drug Applications (NDAs), and other regulatory filings.
• Research & Development: Supports synthetic route optimization and impurity fate and tolerance studies during API process development.

Basic Information

Product Name	Nifedipine Impurity J
CAS No.	114709-68-1
Molecular Formula	C17H18N2O6
Molecular Weight	346.34 g/mol
Synonyms	Dimethyl 2,6-dimethyl-4-(2-nitrophenyl)-1,4-dihydropyridine-3,5-dicarboxylate Impurity J; 1,4-Dihydro-2,6-dimethyl-4-(2-nitrophenyl)-3,5-pyridinedicarboxylic acid dimethyl ester impurity J; Nifedipine Related Compound J; Nitrendipine Impurity (related); 3,5-Pyridinedicarboxylic acid, 1,4-dihydro-2,6-dimethyl-4-(2-nitrophenyl)-, dimethyl ester impurity; Nifedipine EP Impurity J; Nifedipine USP Impurity J
EINECS	Contact for details

Quality Control

Our Nifedipine Impurity J is manufactured under strict quality systems and undergoes rigorous analytical testing to ensure it meets the highest standards for pharmaceutical reference materials. Each batch is characterized and qualified using advanced techniques including HPLC, GC-MS, and NMR to confirm identity and purity. Certificates of Analysis (COA) with detailed chromatographic data are provided, supporting compliance with ICH Q3A, USP, and European Pharmacopoeia guidelines for impurities.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and light-sensitive; therefore, containers must be kept tightly sealed and desiccated to maintain stability and purity.

Specification

Item	Specification
Appearance	Yellow to light brown powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.5% 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.