Description

(S)-o-Desmethyl Rabeprazole Impurity is a high-purity reference standard used for analytical and research purposes. This compound is critical for the quality control and regulatory compliance of rabeprazole sodium, a widely prescribed proton pump inhibitor. Pharmaceutical manufacturers and analytical laboratories require this impurity standard to ensure drug safety, efficacy, and to meet stringent pharmacopeial requirements for impurity profiling.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of impurities in rabeprazole sodium active pharmaceutical ingredient (API) and finished dosage forms.
• Analytical Method Development & Validation: Essential for developing, validating, and calibrating HPLC, UPLC, and LC-MS methods in quality control laboratories.
• Regulatory Compliance & Filing: Supports regulatory submissions (e.g., to FDA, EMA) by providing necessary impurity data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Stability Studies: Used to monitor the formation of this specific degradation product during forced degradation and long-term stability testing of rabeprazole formulations.
• Pharmacopeial Testing: Aids in compliance testing against monographs in the United States Pharmacopeia (USP), European Pharmacopoeia (Ph. Eur.), and other international pharmacopeias.
• Research & Development: Serves as a key intermediate or marker in synthetic chemistry research and metabolic studies related to rabeprazole.

Basic Information

Product Name	(S)-o-Desmethyl Rabeprazole Impurity
CAS No.	179952-05-7
Molecular Formula	C17H20N3O3S
Molecular Weight	346.43 g/mol
Synonyms	(S)-2-[[[4-(3-Methoxypropoxy)-3-methyl-2-pyridinyl]methyl]sulfinyl]-1H-benzimidazole; (S)-Omeprazole Sulfide Impurity; (S)-H 168/68; (S)-Desmethyl Rabeprazole; (S)-Desmethyl Rabeprazole Sulfide; (S)-o-Desmethyl Rabeprazole; Rabeprazole Impurity F (S-isomer); (S)-Form of o-Desmethyl Rabeprazole
EINECS	Contact for details

Quality Control

Every batch of (S)-o-Desmethyl Rabeprazole Impurity is manufactured and tested under strict quality management systems. Our products undergo rigorous analytical testing, including HPLC purity assay, chiral purity determination, and identity confirmation (IR, MS) to ensure compliance with industry standards. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment, supporting traceability and regulatory requirements.

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.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Chiral Purity (Chiral HPLC)	≥ 99.0% (S-isomer)
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 1.0% w/w

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