Description

Ilaprazole Impurity 7 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, analytical laboratories, and regulatory bodies for method development, validation, and impurity profiling studies.

Application

• Pharmaceutical Reference Standard for the identification and quantification of impurities in Ilaprazole API and finished dosage forms.
• Analytical Method Development and validation in quality control (QC) and research & development (R&D) laboratories.
• Stability Studies to monitor impurity profiles and degradation pathways of Ilaprazole under various storage conditions.
• Regulatory Compliance and documentation, supporting submissions to agencies like the FDA, EMA, and PMDA.
• Pharmacopoeial Testing, serving as a system suitability and calibration standard for compendial methods.
• Academic and Clinical Research investigating the metabolism, pharmacokinetics, and safety profile of Ilaprazole.

Basic Information

Product Name	Ilaprazole Impurity 7
CAS No.	1360824-57-2
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Ilaprazole Related Compound 7; Ilaprazole EP Impurity 7; Ilaprazole USP Impurity 7; Ilaprazole Process Impurity; 2-[[(4-Methoxy-3-methylpyridin-2-yl)methyl]sulfinyl]-5-(difluoromethoxy)-1H-benzimidazole Impurity; 5-(Difluoromethoxy)-2-[[(4-methoxy-3-methyl-2-pyridinyl)methyl]sulfinyl]-1H-benzimidazole Impurity
EINECS	Contact for details

Quality Control

Our Ilaprazole Impurity 7 is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC, NMR, and MS, to ensure identity, purity, and traceability. Certificates of Analysis (COA) with detailed chromatographic data are provided to support your regulatory and research needs. We adhere to relevant ICH guidelines for impurity standards.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. For long-term storage, consider storing at 2-8°C. Handle the material under appropriate laboratory conditions to prevent contamination.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Retention time matches reference standard
Identification (IR)	Spectrum conforms to reference
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	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.