Description

Ilaprazole Impurity 23 is a designated impurity standard used in the analytical profiling and quality control of the active pharmaceutical ingredient Ilaprazole. This compound is critical for ensuring the purity, safety, and efficacy of the final drug product by serving as a reference marker in chromatographic analysis. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in the development and quality assurance of proton pump inhibitor medications.

Application

• Primary use as a certified reference standard (CRS) for the identification and quantification of impurities in Ilaprazole API.
• Critical component in analytical method development and validation (HPLC, UPLC, LC-MS) for pharmaceutical quality control.
• Essential for stability studies and degradation pathway elucidation of Ilaprazole formulations.
• Used in regulatory compliance and submission dossiers to meet ICH Q3A(R2) and Q3B(R2) guidelines.
• Serves as a key material for pharmacopoeial testing to ensure compliance with USP, EP, or other pharmacopoeia standards.
• Supports research and development activities in process chemistry and impurity synthesis.

Basic Information

Product Name	Ilaprazole Impurity 23
CAS No.	2285346-40-7
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Ilaprazole Related Compound 23; Ilaprazole Impurity K; Ilaprazole EP Impurity K; Ilaprazole USP Impurity; 2-[[(4-Methoxy-3-methyl-2-pyridinyl)methyl]sulfinyl]-5-(1H-pyrrol-1-yl)-1H-benzimidazole Impurity; Ilaprazole Degradation Product; Ilaprazole Process Impurity
EINECS	Contact for details

Quality Control

Every batch of Ilaprazole Impurity 23 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous quality testing, including advanced chromatographic techniques, to ensure identity, purity, and compliance with industry standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results. We support compliance with ICH, USP, and EP guidelines for pharmaceutical impurities.

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. Keep the container in a dry, cool, and well-ventilated place. Handle and store in accordance with good laboratory practices.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single impurity ≤ 1.0% Total impurities ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 5.0%

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