Description

Ilaprazole Impurity 21 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of the active pharmaceutical ingredient Ilaprazole. It is primarily required by pharmaceutical manufacturers and analytical laboratories for method development, validation, and routine quality control testing of drug substances and products.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the identification and quantification of related substances in Ilaprazole API and finished dosage forms.
• Analytical Method Development: Essential for developing and validating stability-indicating HPLC, UPLC, or LC-MS methods in pharmaceutical R&D.
• Quality Control & Assurance: Serves as a system suitability and calibration standard in routine QC labs to monitor impurity profiles and ensure batch-to-batch consistency.
• Regulatory Compliance & Filing: Supports regulatory submissions (e.g., for FDA, EMA) by providing characterized impurity data required for drug master files (DMFs) and CMC sections.
• Stability Studies: Employed to track the formation and level of this specific degradation product under various stress conditions (e.g., heat, light, humidity).
• Process Chemistry Research: Used to study and optimize synthetic pathways to minimize the formation of this impurity during Ilaprazole manufacturing.

Basic Information

Product Name	Ilaprazole Impurity 21
CAS No.	2285346-38-3
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Ilaprazole Related Compound 21; Ilaprazole Impurity K; Ilaprazole EP Impurity K; Ilaprazole USP Impurity; Ilaprazole Degradation Product; 2-[[(4-Methoxy-3-methylpyridin-2-yl)methyl]sulfinyl]-6-(1H-pyrrol-1-yl)-1H-benzimidazole Impurity; Ilaprazole Specified Impurity
EINECS	Contact for details

Quality Control

Our Ilaprazole Impurity 21 is manufactured under strict quality systems. Each batch undergoes comprehensive analytical characterization using advanced techniques such as HPLC, LC-MS, NMR, and IR to confirm identity and purity. A detailed Certificate of Analysis (COA) is provided, listing batch-specific results for purity, impurities, and residual solvents, ensuring compliance with ICH Q3A, Q3B, and relevant pharmacopeial guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or COA. The product is hygroscopic (moisture-sensitive) and should be handled in a dry environment to maintain stability.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time matches reference standard
Identification (IR)	Spectrum conforms to reference spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 5.0%
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C

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