Description

Nifedipine Impurity 22 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. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and impurity profiling studies.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference material for the identification and quantification of specific impurities in Nifedipine API batches.
• Analytical Method Development: Serves as a critical standard for developing and validating HPLC, UPLC, or GC methods in quality control laboratories.
• Stability Studies: Employed to monitor the formation of degradation products in Nifedipine formulations under various stress conditions.
• Regulatory Compliance & Documentation: Essential for preparing regulatory submission documents (e.g., for FDA, EMA) that require detailed impurity characterization.
• Research & Development: Used in R&D to study the degradation pathways and metabolism of Nifedipine.
• Quality Control & Assurance: Acts as a primary standard for routine quality control testing to ensure API purity meets pharmacopeial specifications (USP, EP).

Basic Information

Product Name	Nifedipine Impurity 22
CAS No.	167710-84-1
Molecular Formula	C17H18N2O6
Molecular Weight	346.34 g/mol
Synonyms	1,4-Dihydro-2,6-dimethyl-4-(2-nitrophenyl)-3,5-pyridinedicarboxylic acid 3-(2-hydroxyethyl) 5-methyl ester; Nifedipine Hydroxyethyl Ester Impurity; Nifedipine Related Compound 22; 3-(2-Hydroxyethyl) 5-methyl 2,6-dimethyl-4-(2-nitrophenyl)-1,4-dihydropyridine-3,5-dicarboxylate; 2-Hydroxyethyl methyl 2,6-dimethyl-4-(2-nitrophenyl)-1,4-dihydropyridine-3,5-dicarboxylate; Nifedipine Impurity F (Hydroxyethyl Ester); Nifedipine Metabolite (Hydroxyethyl Derivative)
EINECS	Contact for details

Quality Control

Every batch of Nifedipine Impurity 22 is manufactured under controlled conditions and undergoes rigorous analytical testing to ensure identity, purity, and consistency. Our quality system is designed to meet the stringent requirements of pharmaceutical reference standard applications. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing results from tests such as HPLC purity, identity confirmation (IR, NMR), and residual solvent analysis.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This product is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation. For long-term storage, consider desiccated conditions.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Water Content (KF)	≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines

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