Description

Ilaprazole Impurity CAS NO 1018229-53-2 is a high-purity chemical reference standard used in the analytical profiling and quality control of Ilaprazole, a proton pump inhibitor. This impurity is critical for pharmaceutical manufacturers and research laboratories to ensure drug safety, efficacy, and regulatory compliance. It is primarily required by professionals in pharmaceutical R&D, quality assurance, and analytical chemistry for method development, validation, and batch release testing.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the identification and quantification of related substances in Ilaprazole Active Pharmaceutical Ingredient (API) and finished dosage forms.
• Analytical Method Development & Validation: Used as a critical component in developing and validating stability-indicating HPLC, UPLC, or LC-MS methods for Ilaprazole.
• Quality Control & Batch Release: Essential for routine quality control testing to monitor impurity levels and ensure batches meet pharmacopeial specifications (e.g., ICH Q3A/B guidelines).
• Stability Studies: Employed in forced degradation and long-term stability studies of Ilaprazole to understand degradation pathways and establish shelf-life.
• Regulatory Submissions: Provides necessary impurity characterization data for regulatory filings with agencies like the FDA, EMA, and other global health authorities.
• Research & Development: Used in synthetic chemistry research to study the formation and fate of this impurity during the manufacturing process of Ilaprazole.

Basic Information

Product Name	Ilaprazole Impurity
CAS No.	1018229-53-2
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Ilaprazole Related Compound; Ilaprazole Impurity Standard; Ilaprazole Process Impurity; Ilaprazole Degradant; Ilaprazole Specified Impurity; 2-[[(4-Methoxy-3-methyl-2-pyridinyl)methyl]sulfinyl]-5-(1H-pyrrol-1-yl)-1H-benzimidazole (Ilaprazole N-Oxide Impurity); Ilaprazole Sulfoxide Impurity; 1018229-53-2
EINECS	Contact for details

Quality Control

Our Ilaprazole Impurity is manufactured under strict quality systems. Each batch undergoes rigorous analytical testing, including HPLC for purity confirmation and structural elucidation via spectroscopic methods (NMR, MS), to ensure it meets the high standards required for pharmaceutical reference materials. Certificates of Analysis (COA) with detailed chromatographic data are provided for traceability and compliance with ICH and cGMP guidelines.

Storage

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

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 1.0% Total impurities: ≤ 5.0%
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.