Description

Nifendipine Impurity G CAS NO 74378-10-2 is a high-purity 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 (API) Nifendipine. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and impurity profiling studies.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the quality control and release testing of Nifendipine API and its finished dosage forms.
• Analytical Method Development: Essential for developing and validating HPLC, UPLC, or GC methods to accurately identify and quantify this specific impurity.
• Stability Studies: Employed to monitor the formation of Nifendipine Impurity G in drug products under various stress conditions to determine shelf life.
• Regulatory Compliance & Filings: Supports regulatory submissions (e.g., to FDA, EMA) by providing necessary impurity characterization data for drug master files (DMFs).
• Research & Development: Used in R&D laboratories to study the degradation pathways and chemical behavior of Nifendipine.
• Pharmacopoeial Testing: Serves as a reference material for testing against pharmacopoeial monographs (e.g., USP, EP) where specified.

Basic Information

Product Name	Nifendipine Impurity G
CAS No.	74378-10-2
Molecular Formula	C18H20N2O6
Molecular Weight	360.36 g/mol
Synonyms	Nifendipine Related Compound G; Nifendipine EP Impurity G; Nifendipine USP Impurity G; 2,6-Dimethyl-4-(3-nitrophenyl)-1,4-dihydropyridine-3,5-dicarboxylic acid 3-ethyl 5-methyl ester (Degradation Product); 3-Ethyl 5-methyl 2,6-dimethyl-4-(3-nitrophenyl)-1,4-dihydropyridine-3,5-dicarboxylate (Impurity); Nifedipine Analog Impurity; 1,4-Dihydropyridine Derivative Impurity
EINECS	Contact for details

Quality Control

Every batch of Nifendipine Impurity G is manufactured under strict quality management systems and undergoes comprehensive analytical characterization. Our products are tested to meet stringent in-house specifications aligned with pharmacopoeial guidelines. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing results for identity, purity, and impurity profile as determined by advanced techniques like HPLC and NMR.

Storage

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

Specification

Item	Specification
Appearance	Yellow to light brown powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unknown impurity ≤ 1.0% Total impurities ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 1.0% w/w

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