Description

Nilvadipine Impurity 1 is a designated impurity standard used in the analytical profiling and quality control of the antihypertensive drug Nilvadipine. This compound is critical for pharmaceutical manufacturers and research laboratories to ensure the purity, safety, and efficacy of the final drug product. It serves as a key reference material for method development, validation, and regulatory compliance in the pharmaceutical industry.

Application

• Pharmaceutical Reference Standard: Primary use as a certified impurity standard for the quality control of Nilvadipine Active Pharmaceutical Ingredient (API) and finished dosage forms.
• Analytical Method Development & Validation: Essential for developing and validating HPLC, UPLC, or LC-MS methods to accurately identify and quantify this specific impurity.
• Stability Studies: Used to monitor the formation and levels of this impurity during forced degradation and long-term stability testing of Nilvadipine.
• Regulatory Compliance & Documentation: Supports the preparation of regulatory submissions (e.g., for FDA, EMA) by providing definitive identification and characterization data for specified impurities.
• Pharmacological Research: Can be utilized in metabolic and pharmacokinetic studies to understand the degradation pathways of Nilvadipine.
• Calibration & System Suitability: Acts as a system suitability test component to ensure the performance and resolution of chromatographic systems.

Basic Information

Item	Details
Product Name	Nilvadipine Impurity 1
CAS No.	1452166-70-9
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Nilvadipine Related Compound 1; Nilvadipine Impurity A; Nilvadipine Specified Impurity; 3,5-Pyridinedicarboxylic acid, 1,4-dihydro-2,6-dimethyl-4-(3-nitrophenyl)-, 3-methyl 5-(1-methylethyl) ester; Isopropyl methyl 1,4-dihydro-2,6-dimethyl-4-(3-nitrophenyl)-3,5-pyridinedicarboxylate impurity
EINECS	Contact for details

Quality Control

Every batch of Nilvadipine Impurity 1 is manufactured and analyzed under strict quality management systems. The product undergoes rigorous identity confirmation, purity assessment, and impurity profiling using advanced analytical techniques such as HPLC, GC, MS, and NMR to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or Certificate of Analysis. Keep the container in a dry, cool, and well-ventilated area.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unspecified impurity ≤ 1.0% Total impurities ≤ 2.0%
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.