Description

Rabeprazole Impurity 2 CAS NO 1807988-36-8 is a high-purity chemical reference standard used for analytical and quality control purposes. This compound is critical for ensuring the safety, efficacy, and regulatory compliance of the active pharmaceutical ingredient (API) Rabeprazole sodium. It is an essential tool for pharmaceutical manufacturers, analytical laboratories, and research institutions involved in method development, validation, and impurity profiling to meet stringent pharmacopeial standards.

Application

• Pharmaceutical Impurity Profiling and Identification: Serves as a certified reference material for the identification and quantification of specific impurities in Rabeprazole sodium drug substance and finished dosage forms.
• Analytical Method Development and Validation: Used as a critical standard to develop, validate, and verify HPLC, UPLC, and other chromatographic methods for impurity analysis.
• Quality Control and Assurance (QC/QA): Employed in routine batch release testing to monitor and control impurity levels, ensuring drug product consistency and compliance with ICH guidelines.
• Regulatory Submissions and Compliance: Provides necessary data for regulatory filings (e.g., FDA, EMA) to establish impurity acceptance criteria and demonstrate control strategies.
• Stability Studies: Used as a marker to track impurity formation and degradation pathways in Rabeprazole formulations under various stress conditions.
• Research and Development: Facilitates process chemistry research, helping to understand and minimize impurity formation during API synthesis.

Basic Information

Product Name	Rabeprazole Impurity 2
CAS No.	1807988-36-8
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Rabeprazole Related Compound 2; Rabeprazole Impurity B; Rabeprazole EP Impurity B; Rabeprazole USP Impurity; 2-[[[4-(3-Methoxypropoxy)-3-methyl-2-pyridinyl]methyl]sulfinyl]-1H-benzimidazole Impurity; 1H-Benzimidazole, 2-[[[4-(3-methoxypropoxy)-3-methyl-2-pyridinyl]methyl]sulfinyl]-, impurity; Rabeprazole Sulfoxide Impurity
EINECS	Contact for details

Quality Control

Our Rabeprazole Impurity 2 is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity and identity confirmation (IR, MS), to ensure it meets the high standards required for pharmaceutical reference materials. Certificates of Analysis (COA) with detailed chromatographic data are provided, supporting compliance with ICH Q3A, Q3B, USP, and EP guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This product is hygroscopic (moisture-sensitive) and must be kept in a desiccated environment to maintain stability and purity.

Specification

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

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