Description

Isradipine Impurity 3 (Isradipine EP Impurity C) is a high-purity reference standard critical for pharmaceutical research and development. This compound is essential for the analytical characterization and quality control of the active pharmaceutical ingredient (API) Isradipine, a calcium channel blocker. It is primarily used by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies to ensure drug purity, safety, and compliance with stringent pharmacopeial standards such as the European Pharmacopoeia (EP).

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the identification and quantification of Isradipine EP Impurity C in drug substances and products.
• Analytical Method Development & Validation: Used in HPLC, LC-MS, and other chromatographic methods to establish specificity, accuracy, and detection limits.
• Quality Control & Assurance (QC/QA): Critical for routine batch testing of Isradipine API to monitor impurity profiles and ensure compliance with ICH guidelines.
• Regulatory Submissions: Provides necessary data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDA).
• Stability Studies: Employed to track the formation of degradation products in Isradipine formulations under various stress conditions.
• Research & Development: Used in synthetic chemistry research to study the degradation pathways and metabolism of Isradipine.

Basic Information

Product Name	Isradipine Impurity 3 (Isradipine EP Impurity C)
CAS No.	75695-84-0
Molecular Formula	C19H21N3O5
Molecular Weight	371.39 g/mol
Synonyms	Isradipine Impurity C; Isradipine Related Compound C; 4-(4-Benzofurazanyl)-1,4-dihydro-2,6-dimethyl-3,5-pyridinedicarboxylic acid methyl 1-methylethyl ester; 3,5-Pyridinedicarboxylic acid, 1,4-dihydro-2,6-dimethyl-4-(2,1,3-benzoxadiazol-4-yl)-, methyl 1-methylethyl ester; Methyl isopropyl 4-(2,1,3-benzoxadiazol-4-yl)-1,4-dihydro-2,6-dimethyl-3,5-pyridinedicarboxylate
EINECS	Contact for details

Quality Control

Every batch of Isradipine Impurity 3 is manufactured and tested under strict quality management systems. Our products undergo rigorous analytical testing, including HPLC purity analysis, to ensure compliance with high-grade reference standard specifications. A comprehensive Certificate of Analysis (COA), detailing identity, purity, and chromatographic data, is provided with each shipment to support your regulatory and quality assurance requirements.

Storage

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

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)	Total impurities ≤ 2.0%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

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