Description

Rabeprazole Impurity 2 is a specified impurity associated with the active pharmaceutical ingredient (API) Rabeprazole Sodium. This compound is critical for analytical reference and quality control processes in pharmaceutical development and manufacturing. It is primarily utilized by research scientists and quality assurance professionals in the pharmaceutical industry to ensure product purity, safety, and regulatory compliance.

Application

• As a certified reference standard for the identification and quantification of impurities in Rabeprazole Sodium API and finished dosage forms.
• For method development and validation of analytical procedures, including HPLC and LC-MS, in quality control laboratories.
• In stability studies to monitor the degradation profile of Rabeprazole-based pharmaceutical products.
• As a critical component in regulatory submissions (e.g., for FDA, EMA) to establish impurity thresholds and control strategies.
• For research and development of new synthetic pathways or purification processes for Rabeprazole.
• Used in pharmacopoeial testing to comply with monograph specifications from USP, EP, or other international standards.

Basic Information

Product Name	Rabeprazole Impurity 2
CAS No.	1163685-31-1
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Rabeprazole Related Compound 2; Rabeprazole Impurity B; 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 systems to ensure high purity and batch-to-batch consistency, suitable for use as a reference standard. Each batch is accompanied by a comprehensive Certificate of Analysis (COA) detailing identity, purity, and impurity profiles as determined by advanced chromatographic and spectroscopic methods. We support compliance with ICH Q3A/B guidelines and pharmacopoeial standards (USP, EP).

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 should be handled in a dry environment to prevent degradation. For long-term storage, consider desiccant use.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual impurity: ≤ 1.0% 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.