Description

Ilaprazole Impurity 22 is a designated impurity standard used in the analytical profiling and quality control of the active pharmaceutical ingredient (API) Ilaprazole. This compound is critical for ensuring the purity, safety, and efficacy of pharmaceutical formulations by serving as a reference marker in chromatographic analysis. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and batch release testing.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Ilaprazole API and finished dosage forms.
• Analytical Method Development: Essential for developing and validating stability-indicating HPLC or UPLC methods in compliance with ICH guidelines.
• Quality Control & Batch Release: A critical component in the quality control workflow to confirm that Ilaprazole batches meet stringent pharmacopeial specifications for impurity limits.
• Stability Studies: Employed to monitor the formation of degradation products under various stress conditions (e.g., heat, light, humidity) during drug product shelf-life studies.
• Regulatory Submissions: Provides necessary impurity characterization data for regulatory filings with agencies like the FDA, EMA, and PMDA.
• Research & Development: Supports synthetic route optimization and impurity fate and tolerance studies during the API development process.

Basic Information

Product Name	Ilaprazole Impurity 22
CAS No.	2285346-39-4
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Ilaprazole Related Compound 22; Ilaprazole Impurity K; Ilaprazole EP Impurity K; Ilaprazole USP Impurity; Ilaprazole Process Impurity; 2-[[(4-Methoxy-3-methyl-2-pyridinyl)methyl]sulfinyl]-5-(1H-pyrrol-1-yl)-1H-benzimidazole (Ilaprazole core structure derivative); Ilaprazole Specified Impurity
EINECS	Contact for details

Quality Control

Every batch of Ilaprazole Impurity 22 is manufactured and analyzed under strict quality management systems. The material undergoes comprehensive characterization and purity verification using advanced analytical techniques including HPLC, LC-MS, and NMR to ensure it meets the high standards required for use as a reference standard. A detailed Certificate of Analysis (COA) is provided with each lot, confirming identity, purity, and chromatographic profile. Our quality commitment aligns with cGMP principles for pharmaceutical impurities.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and must be handled in a dry environment to prevent degradation. For long-term storage, consider desiccated conditions.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (MS)	Mass spectrum conforms to structure
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any single unknown impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 5.0% w/w

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