Description

Isradipine Ep Impurity A is a high-purity chemical reference standard, specifically identified as a key impurity in the synthesis and quality control of the active pharmaceutical ingredient (API) Isradipine. This compound is critical for pharmaceutical manufacturers and analytical laboratories to ensure product safety, efficacy, and regulatory compliance. It is primarily used in the research, development, and quality assurance processes within the global pharmaceutical industry.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the analytical method development and validation of Isradipine API and finished dosage forms.
• Quality Control (QC) Testing: Used in routine QC laboratories for the identification and quantification of this specific impurity to ensure batch-to-batch consistency and purity.
• Regulatory Compliance & Documentation: Essential for preparing regulatory submission documents (e.g., for FDA, EMA) to demonstrate comprehensive impurity profiling and control strategies.
• Research & Development (R&D): Employed in process chemistry R&D to study degradation pathways, optimize synthesis routes, and establish impurity limits.
• Stability Studies: Acts as a marker in forced degradation and long-term stability studies of Isradipine to monitor impurity formation over time and under various conditions.
• Calibration of Analytical Instruments: Used to calibrate HPLC, UPLC, and LC-MS systems for accurate and precise impurity analysis.

Basic Information

Product Name	Isradipine Ep Impurity A
CAS No.	75695-99-7
Molecular Formula	C19H21N3O5
Molecular Weight	371.39 g/mol
Synonyms	Isradipine Impurity A; Isradipine Related Compound A; 4-(4-Benzofurazanyl)-1,4-dihydro-2,6-dimethyl-3,5-pyridinedicarboxylic acid methyl 1-methylethyl ester; Methyl isopropyl 2,6-dimethyl-4-(2,1,3-benzoxadiazol-4-yl)-1,4-dihydropyridine-3,5-dicarboxylate; 3,5-Pyridinedicarboxylic acid, 1,4-dihydro-2,6-dimethyl-4-(2,1,3-benzoxadiazol-4-yl)-, methyl 1-methylethyl ester
EINECS	Contact for details

Quality Control

Our Isradipine Ep Impurity A is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC purity assay and identity confirmation (IR, MS), 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 every shipment.

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 must be kept in a desiccated environment to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual unknown impurity ≤ 0.5%
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.