Description

Nilvadipine Impurity C is a designated impurity reference standard used in the analytical profiling and quality control of the antihypertensive drug Nilvadipine. This high-purity compound is critical for pharmaceutical manufacturers and analytical laboratories to ensure drug safety, efficacy, and regulatory compliance. It is primarily utilized by R&D scientists and QC professionals in the pharmaceutical industry for method development, validation, and batch release testing.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the identification and quantification of Nilvadipine Impurity C in active pharmaceutical ingredient (API) and finished drug product analysis.
• Method Development and Validation: Essential for developing and validating stability-indicating analytical methods, such as HPLC and UPLC, to monitor impurity profiles.
• Quality Control & Assurance: Used in routine batch testing to ensure Nilvadipine drug substances and products meet stringent pharmacopeial (e.g., USP, EP) and ICH Q3A/B guidelines for impurities.
• Stability Studies: Employed as a marker to track the formation of degradation products under various stress conditions (e.g., heat, light, humidity) during drug stability testing.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., FDA, EMA) to establish impurity limits and control strategies.
• Research and Development: Supports process chemistry research to understand and minimize the formation of this specific impurity during API synthesis.

Basic Information

Item	Detail
Product Name	Nilvadipine Impurity C
CAS No.	849683-74-5
Molecular Formula	C19H19N3O6
Molecular Weight	385.37 g/mol
Synonyms	5-Isopropyl 3-methyl 2-cyano-6-methyl-4-(3-nitrophenyl)-1,4-dihydropyridine-3,5-dicarboxylate; 3,5-Dimethyl 2-cyano-6-methyl-4-(3-nitrophenyl)-1,4-dihydropyridine-3,5-dicarboxylate; Nilvadipine Related Compound C; Nilvadipine Impurity 3; 1,4-Dihydro-2,6-dimethyl-4-(3-nitrophenyl)-3,5-pyridinedicarboxylic acid, 3-methyl 5-(1-methylethyl) ester, 2-cyano-; 3-Methyl 5-(1-methylethyl) 2-cyano-1,4-dihydro-6-methyl-4-(3-nitrophenyl)-3,5-pyridinedicarboxylate
EINECS	Contact for details

Quality Control

Our Nilvadipine Impurity C is manufactured under strict quality systems. Each batch undergoes rigorous analytical testing, including HPLC purity determination and spectroscopic identification (IR, NMR, MS), to ensure it meets the high standards required for use as a reference material. A comprehensive Certificate of Analysis (COA) is provided, detailing batch-specific results and confirming compliance with in-house specifications aligned with ICH guidelines.

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 (store away from light).

Specification

Item	Specification
Appearance	Yellow to light brown powder
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any single unknown impurity ≤ 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.