Description

(R)-o-Desmethyl Rabeprazole Impurity is a high-purity chemical reference standard critical for pharmaceutical research and development. This compound serves as a specified impurity in the analysis and quality control of Rabeprazole, a widely used proton pump inhibitor. It is essential for analytical chemists and quality assurance professionals in the pharmaceutical industry who require precise standards for method validation, stability studies, and regulatory compliance. Ensuring the integrity of your drug substance requires access to well-characterized impurities like this one.

Application

• Pharmaceutical Reference Standard: Used 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 and Validation: Critical for developing, optimizing, and validating HPLC, UPLC, or LC-MS methods to monitor impurity profiles.
• Stability Indicating Method: Employed in forced degradation studies and routine stability testing to track the formation of this specific degradation product over time.
• Quality Control & Batch Release: Essential for in-house QC laboratories to ensure Rabeprazole batches meet pharmacopeial specifications (e.g., USP, EP, ICH Q3A/B) for impurity limits.
• Regulatory Submissions: Provides necessary data for Drug Master Files (DMFs), Investigational New Drug (IND) applications, and New Drug Applications (NDAs) to satisfy regulatory requirements for impurity characterization.
• Process Chemistry Research: Used by R&D scientists to understand and mitigate the formation of this impurity during the synthesis and purification of Rabeprazole.

Basic Information

Product Name	(R)-o-Desmethyl Rabeprazole Impurity
CAS No.	179952-04-6
Molecular Formula	C17H20N3O3S
Molecular Weight	346.42 g/mol
Synonyms	(R)-Desmethyl Rabeprazole; (R)-o-Desmethyl Rabeprazole; (R)-2-[[[4-(3-Methoxypropoxy)-3-methyl-2-pyridinyl]methyl]sulfinyl]-1H-benzimidazole; Rabeprazole Impurity F (R-isomer); (R)-Rabeprazole Sulfoxide Impurity; (R)-Desmethoxy Rabeprazole; (R)-HMR-3562-00; (R)-o-Desmethyl Rabeprazole Sulfoxide
EINECS	Contact for details

Quality Control

Every batch of (R)-o-Desmethyl Rabeprazole Impurity is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced analytical techniques such as HPLC, LC-MS, NMR, and IR spectroscopy to ensure compliance with industry and pharmacopeial standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results. We support compliance with ICH Q3A, Q3B, USP, and EP guidelines for impurities in new drug substances and products.

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 compound is hygroscopic (moisture-sensitive); the container must be kept tightly sealed in a dry environment to prevent degradation. For long-term storage, consider storing under an inert atmosphere.

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)	Any individual impurity ≤ 0.5% Total impurities ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 0.5%

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