Description

Nifedipine Impurity F CAS NO 53055-15-5 is a specified impurity used in the quality control and analytical research of the antihypertensive drug Nifedipine. This compound is critical for pharmaceutical manufacturers and analytical laboratories to ensure drug purity, safety, and regulatory compliance. It serves as a key reference standard for method development, validation, and stability testing in the production of Nifedipine and its related pharmaceutical formulations.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of impurities in Nifedipine Active Pharmaceutical Ingredient (API) and finished dosage forms.
• Analytical Method Development: Essential for developing and validating High-Performance Liquid Chromatography (HPLC), Ultra-Performance Liquid Chromatography (UPLC), and other chromatographic methods in quality control laboratories.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., for FDA, EMA) by providing necessary impurity profiles and supporting data for drug master files (DMFs) and Common Technical Documents (CTDs).
• Stability Studies: Used to monitor the formation of degradation products in Nifedipine formulations under various stress conditions (e.g., heat, light, humidity) as per ICH guidelines.
• Pharmacopoeial Testing: Employed in testing to meet the stringent purity criteria set forth in pharmacopoeias such as USP (United States Pharmacopeia), EP (European Pharmacopoeia), and BP (British Pharmacopoeia).
• Research & Development: Utilized in R&D for studying the degradation pathways and metabolism of Nifedipine, aiding in the development of more stable and effective drug formulations.

Basic Information

Product Name	Nifedipine Impurity F
CAS No.	53055-15-5
Molecular Formula	C17H18N2O6
Molecular Weight	346.34 g/mol
Synonyms	1,4-Dihydro-2,6-dimethyl-4-(2-nitrophenyl)-3,5-pyridinedicarboxylic Acid Dimethyl Ester; Dimethyl 2,6-dimethyl-4-(2-nitrophenyl)-1,4-dihydropyridine-3,5-dicarboxylate; Nifedipine Impurity F (EP); Nifedipine Related Compound F; Nifedipine Degradation Product; 3,5-Pyridinedicarboxylic acid, 1,4-dihydro-2,6-dimethyl-4-(2-nitrophenyl)-, dimethyl ester; ADR/NIF/001
EINECS	Contact for details

Quality Control

Our Nifedipine Impurity F is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity confirmation and structural verification via spectroscopic methods (IR, NMR, MS), to ensure it meets the high standards required for pharmaceutical reference materials. Certificates of Analysis (COA) with detailed chromatograms and batch-specific data are provided to support your regulatory and quality assurance needs.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, 15-25°C (59-77°F), in a dry environment. The product is light-sensitive and should be handled under appropriate conditions to prevent degradation.

Specification

Item	Specification
Appearance	Yellow to orange crystalline powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time corresponds to reference
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single 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.