Description

Rabeprazole Impurity 8 is a designated impurity standard used in the analytical profiling and quality control of the active pharmaceutical ingredient (API) Rabeprazole Sodium. 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 for method development, validation, and batch release testing.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Rabeprazole Impurity 8 in Rabeprazole Sodium API and finished dosage forms.
• Analytical Method Development & Validation: Essential for developing and validating stability-indicating HPLC/LC-MS methods to monitor impurity profiles.
• Quality Control & Batch Release: Employed in routine QC testing to ensure API and drug product batches comply with stringent pharmacopeial (e.g., USP, EP) and ICH Q3A/B guidelines for impurities.
• Stability Studies: Acts as a critical marker in forced degradation and long-term stability studies to understand the degradation pathways of Rabeprazole.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., ANDA, NDA) to demonstrate comprehensive impurity control strategies.
• Research & Development: Used in R&D to study the synthesis, formation, and characterization of process-related impurities.

Basic Information

Product Name	Rabeprazole Impurity 8
CAS No.	1613482-73-7
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Rabeprazole Related Compound 8; Rabeprazole EP Impurity J; Rabeprazole USP Impurity; 2-[[[4-(3-Methoxypropoxy)-3-methyl-2-pyridinyl]methyl]sulfinyl]-1H-benzimidazole Impurity; Rabeprazole Sulfoxide Impurity; Desmethyl Rabeprazole Sulfoxide; Potential degradation product of Rabeprazole
EINECS	Contact for details

Quality Control

Every batch of Rabeprazole Impurity 8 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing using advanced techniques like HPLC, LC-MS, and NMR to ensure compliance with pharmacopeial standards and customer specifications. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results.

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 under inert conditions or in a desiccator to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Conforms
Identification (IR)	Conforms to reference spectrum
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual unknown 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.