Description

Isradipine Impurity 2 (Isradipine EP Impurity B) is a high-purity reference standard critical for pharmaceutical research and development. This compound is essential for the accurate identification, quantification, and control of process-related impurities in Isradipine active pharmaceutical ingredient (API) and finished drug products. It is primarily used by analytical laboratories, quality control units, and regulatory affairs departments within the global pharmaceutical and contract research organization (CRO) sectors to ensure product safety, efficacy, and compliance with stringent pharmacopoeial standards.

Application

• Pharmaceutical Impurity Profiling and Characterization: Serves as a certified reference material for method development and validation in HPLC, UPLC, and LC-MS analyses.
• Quality Control and Assurance (QC/QA): Used as a system suitability standard and for routine batch testing of Isradipine API to monitor impurity levels against ICH Q3A/B guidelines.
• Regulatory Submission and Compliance: Provides essential data for Drug Master Files (DMFs), Common Technical Documents (CTD), and submissions to agencies like the FDA and EMA.
• Stability Studies: Employed to track the formation and growth of this specific impurity under various stress conditions (forced degradation studies).
• Pharmaceutical R&D: Aids in process chemistry optimization to understand and minimize the formation of this impurity during API synthesis.
• Calibration Standard: Used to prepare calibration curves for the precise quantification of Isradipine Impurity 2 in test samples.

Basic Information

Product Name	Isradipine Impurity 2 (Isradipine EP Impurity B)
CAS No.	1352916-15-4
Molecular Formula	C19H21N3O5
Molecular Weight	371.39 g/mol
Synonyms	Isradipine Related Compound B; Isradipine Impurity B; 4-(4-Benzofurazanyl)-1,4-dihydro-2,6-dimethyl-3,5-pyridinedicarboxylic acid methyl 1-methylethyl ester; Methyl isopropyl 4-(2,1,3-benzoxadiazol-4-yl)-2,6-dimethyl-1,4-dihydropyridine-3,5-dicarboxylate; Isradipine Process Impurity; Isradipine EP Impurity B
EINECS	Contact for details

Quality Control

Every batch of Isradipine Impurity 2 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced chromatographic and spectroscopic techniques (HPLC, GC, NMR, MS) to ensure compliance with pharmacopoeial standards. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment to support your regulatory and quality requirements.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. The product is light-sensitive and should be handled under appropriate conditions to maintain stability.

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)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual unknown impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 0.5% w/w

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