Description

Nifedipine Impurity H CAS NO 74936-71-3 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and efficacy of the active pharmaceutical ingredient (API) Nifedipine by serving as a key marker for identification and quantification during impurity profiling. It is an essential tool for pharmaceutical manufacturers, analytical laboratories, and regulatory bodies focused on compliance and quality control. The availability of this well-characterized impurity supports the development and validation of robust analytical methods.

Application

• Primary use as a certified reference standard for the identification and quantification of impurities in Nifedipine API.
• Critical component in method development and validation for HPLC, UPLC, and other chromatographic techniques.
• Essential for pharmaceutical quality control (QC) and quality assurance (QA) laboratories to meet ICH guidelines.
• Used in stability studies to monitor impurity formation in Nifedipine formulations over time.
• Supports regulatory submissions (e.g., for FDA, EMA) by providing necessary impurity data.
• Valuable for research and development into the degradation pathways and metabolism of Nifedipine.

Basic Information

Product Name	Nifedipine Impurity H
CAS No.	74936-71-3
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 Nitroso Analog; Nifedipine Nitroso Impurity; Nifedipine Related Compound H; 4-(2-Nitrosophenyl)-2,6-dimethyl-1,4-dihydropyridine-3,5-dicarboxylic acid dimethyl ester; Dimethyl 4-(2-nitrosophenyl)-2,6-dimethyl-1,4-dihydropyridine-3,5-dicarboxylate; Nifedipine Nitroso Derivative
EINECS	Contact for details

Quality Control

Every batch of Nifedipine Impurity H is manufactured and analyzed under strict quality systems. Our products undergo rigorous quality testing, including advanced chromatographic and spectroscopic methods, to ensure compliance with industry standards for reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing purity, identity, and impurity profiles. We support compliance with ICH Q3A/B guidelines and other relevant pharmacopeial standards.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. This material is light-sensitive (store away from light).

Specification

Item	Specification
Appearance	Yellow to orange powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 0.5%

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