Description

Nifedipine Impurity 1 CAS NO 161838-99-9 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 (API) Nifedipine, a widely prescribed calcium channel blocker. It is an essential tool for pharmaceutical manufacturers, analytical laboratories, and research institutions involved in method development, stability studies, and impurity profiling to meet stringent pharmacopeial standards like USP and ICH guidelines.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference material for the identification and quantification of specific impurities in Nifedipine API and finished dosage forms.
• Analytical Method Development & Validation: Serves as a critical standard for developing, optimizing, and validating HPLC, UPLC, or LC-MS methods in quality control laboratories.
• Stability Studies & Forced Degradation: Employed to monitor and characterize degradation products formed during stability testing of Nifedipine under various stress conditions.
• Regulatory Compliance & Documentation: Essential for preparing regulatory submission documents (e.g., for FDA, EMA) that require detailed impurity identification and control strategies.
• Quality Control & Batch Release Testing: Used in routine QC testing to ensure Nifedipine batches meet specified purity limits and are free from unacceptable levels of this impurity.
• Research & Development: Supports R&D activities focused on understanding the synthesis pathways, degradation mechanisms, and metabolic pathways of Nifedipine.

Basic Information

Product Name	Nifedipine Impurity 1
CAS No.	161838-99-9
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 Impurity; Nifedipine Related Compound A; Dimethyl 1,4-dihydro-2,6-dimethyl-4-(2-nitrophenyl)pyridine-3,5-dicarboxylate Impurity; 3,5-Pyridinedicarboxylic acid, 1,4-dihydro-2,6-dimethyl-4-(2-nitrophenyl)-, dimethyl ester, impurity; Nifedipine Degradant; Nitrophenyl DHP Impurity
EINECS	Contact for details

Quality Control

Our Nifedipine Impurity 1 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 tests including Identification (IR, HPLC), Assay (by HPLC), and related substance analysis. We adhere to high standards suitable for pharmaceutical R&D and quality control applications. 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) in a dry environment. This material is light-sensitive (store away from light).

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Assay (HPLC)	≥ 98.0%
Purity (HPLC)	≥ 98.5%
Related Substances (HPLC)	Total impurities ≤ 1.5% Any individual 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.