Description

Nifedipine Impurity 21 CAS NO 80742-13-8 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of the active pharmaceutical ingredient Nifedipine. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and research institutions involved in method development, stability studies, and impurity profiling. The availability of this well-characterized impurity standard is essential for maintaining stringent quality control in drug production.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Nifedipine API and finished dosage forms.
• Analytical Method Development & Validation: Serves as a critical component in developing and validating HPLC, UPLC, or GC methods for impurity analysis.
• Quality Control & Assurance (QC/QA): Employed in routine batch release testing to monitor and control impurity levels according to ICH guidelines and pharmacopeial standards (USP, EP).
• Stability Studies: Used to track the formation and growth of this specific impurity under various stress conditions (e.g., heat, light, humidity) during drug product shelf-life studies.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., ANDA, NDA) to demonstrate thorough impurity characterization and control strategies.
• Research & Development: Utilized in pharmaceutical R&D to understand degradation pathways and the chemical behavior of Nifedipine.

Basic Information

Product Name	Nifedipine Impurity 21
CAS No.	80742-13-8
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Nifedipine Related Compound; Nifedipine Degradant; Nifedipine Process Impurity; Dimethyl 2,6-dimethyl-4-(2-nitrophenyl)-1,4-dihydropyridine-3,5-dicarboxylate Impurity; 1,4-Dihydropyridine Impurity; DHP Impurity; Nitrendipine Impurity (related structure); Contact for additional synonyms.
EINECS	Contact for details

Quality Control

Our Nifedipine Impurity 21 is manufactured under controlled conditions and undergoes rigorous analytical testing to ensure identity, purity, and consistency. Each batch is supplied with a comprehensive Certificate of Analysis (COA) detailing results from advanced techniques such as HPLC, GC, NMR, and MS. We adhere to ICH Q3A, Q3B, and relevant pharmacopeial guidelines to meet the exacting standards of the global pharmaceutical industry. Certificates of Analysis (COA) are available upon request.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the certificate of analysis. Keep the container in a dry, cool, and well-ventilated place. Handle and store in accordance with good laboratory practices.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 2.0%

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