Description

Rabeprazole Impurity 11 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 involved in research, development, and quality assurance of proton pump inhibitor medications.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Rabeprazole Sodium API and its formulations.
• Method Development and Validation: Essential for developing, optimizing, and validating analytical methods, particularly High-Performance Liquid Chromatography (HPLC) and related techniques.
• Quality Control (QC) Testing: Employed in routine batch release testing to monitor impurity levels and ensure compliance with pharmacopeial standards (e.g., USP, EP, ICH Q3A/B).
• Stability Studies: Used to track the formation of degradation products during forced degradation and long-term stability studies of Rabeprazole products.
• Regulatory Submissions: Supports the preparation of regulatory documentation (e.g., CMC sections for ANDA, NDA) by providing impurity characterization data.
• Research and Development: Facilitates impurity profiling during the synthesis process development and scale-up of Rabeprazole.

Basic Information

Product Name	Rabeprazole Impurity 11
CAS No.	1632219-80-7
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Rabeprazole Related Compound 11; Rabeprazole Impurity; Rabeprazole EP Impurity 11; Rabeprazole USP Impurity; 2-[[[4-(3-Methoxypropoxy)-3-methyl-2-pyridinyl]methyl]sulfinyl]-1H-benzimidazole Impurity 11; Desmethyl Rabeprazole Impurity; Rabeprazole Degradation Product
EINECS	Contact for details

Quality Control

Our Rabeprazole Impurity 11 is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing to ensure high purity and accurate identification, meeting the stringent requirements for pharmaceutical reference standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing results for identity, purity, and related substances as per relevant ICH guidelines.

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 storing under inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any individual impurity ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 5.0%

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