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 quality control testing. The precise characterization of this impurity is essential for meeting stringent pharmacopeial standards.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the identification and quantification of Ilaprazole Impurity 7 in bulk drug substances and finished dosage forms.
• Analytical Method Development & Validation: Essential for developing and validating stability-indicating HPLC, UPLC, or LC-MS methods for Ilaprazole.
• Quality Control & Assurance (QC/QA): Employed in routine batch release testing to monitor and control impurity levels, ensuring product safety and efficacy.
• Regulatory Compliance & Filings: Supports regulatory submissions (e.g., ANDA, NDA) by providing necessary impurity data to agencies like the US FDA, EMA, and others.
• Stability Studies: Used to track the formation of this specific degradation product under various stress conditions (e.g., heat, light, humidity).
• Research & Development: Facilitates research into the degradation pathways, pharmacokinetics, and metabolic profile of Ilaprazole.

Basic Information

Product Name	Ilaprazole Impurity 7
CAS No.	1360824-56-1
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Ilaprazole Related Compound 7; Ilaprazole EP Impurity 7; Ilaprazole USP Impurity 7; Ilaprazole Degradation Product 7; Ilaprazole Process Impurity 7; (S)-5-(Difluoromethoxy)-2-[[(3,4-dimethoxy-2-pyridinyl)methyl]sulfinyl]-1H-benzimidazole Impurity; 1H-Benzimidazole, 5-(difluoromethoxy)-2-[[(3,4-dimethoxy-2-pyridinyl)methyl]sulfinyl]-, (S)- (Impurity)
EINECS	Contact for details

Quality Control

Every batch of Ilaprazole Impurity 7 is manufactured and analyzed under strict quality management systems. The product undergoes rigorous testing to ensure identity, purity, and consistency, aligning with current pharmacopeial expectations (e.g., USP, EP, ICH guidelines). A comprehensive Certificate of Analysis (COA) detailing batch-specific results for purity, related substances, and identification tests is provided with each shipment.

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 kept in a desiccated environment to maintain stability and purity. Handle the container with care to prevent moisture ingress.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 1.0%

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