Description

Ilaprazole Impurity 5 (Ilaprazole Pyridine n-Oxide) 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 during the manufacture of Ilaprazole, a proton pump inhibitor. It is primarily required by analytical laboratories, quality control units, and regulatory affairs departments within the pharmaceutical and fine chemical industries to ensure drug safety, efficacy, and compliance with stringent regulatory guidelines.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material (CRM) for the calibration of analytical instruments and validation of testing methods in QC/QA laboratories.
• Method Development and Validation: Used in developing and validating High-Performance Liquid Chromatography (HPLC), Ultra-Performance Liquid Chromatography (UPLC), and mass spectrometry methods for impurity profiling.
• Regulatory Compliance and Filing: Critical for preparing regulatory submission documents (e.g., for FDA, EMA) to demonstrate comprehensive impurity control and characterization as per ICH Q3A and Q3B guidelines.
• Stability Studies: Employed in forced degradation and long-term stability studies of Ilaprazole drug substance and products to monitor impurity formation.
• Process Chemistry Research: Used by R&D scientists to study and optimize synthesis pathways, helping to minimize the formation of this specific impurity.
• Quality Control Testing: Acts as a system suitability standard in routine batch release testing of Ilaprazole Active Pharmaceutical Ingredients (APIs).

Basic Information

Product Name	Ilaprazole Impurity 5 (Ilaprazole Pyridine n-Oxide)
CAS No.	2285346-44-1
Molecular Formula	C19H18N4O3S
Molecular Weight	382.44 g/mol
Synonyms	Ilaprazole N-Oxide Impurity; Ilaprazole Pyridine N-Oxide; Ilaprazole Related Compound 5; 2-[[(4-Methoxy-3-methylpyridin-2-yl)methyl]sulfinyl]-5-(1H-pyrrol-1-yl)-1H-benzimidazole 4-Oxide; 5-(1H-Pyrrol-1-yl)-2-[[(4-methoxy-3-methyl-2-pyridinyl)methyl]sulfinyl]-1H-benzimidazole 4-Oxide; IY-81149 N-Oxide Impurity
EINECS	Contact for details

Quality Control

Every batch of Ilaprazole Impurity 5 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous quality testing to ensure compliance with industry standards. Comprehensive characterization is performed using advanced techniques including HPLC, UPLC, NMR, and MS to confirm identity and purity. Certificates of Analysis (COA) detailing batch-specific results are available upon request, supporting your regulatory and quality assurance needs.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, 15-25°C (59-77°F), in a dry environment. The product is hygroscopic (moisture-sensitive) and should be handled under anhydrous conditions to maintain stability.

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)	Individual unknown impurity: ≤ 0.5% 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.