Description

Omeprazole Impurity 25 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of the active pharmaceutical ingredient (API) Omeprazole. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and impurity profiling. The precise characterization of this impurity is essential for meeting stringent pharmacopeial standards in drug development and quality control.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Omeprazole API and finished dosage forms.
• Analytical Method Development: Essential for developing and validating HPLC, UPLC, or LC-MS methods for impurity detection and separation.
• Quality Control & Assurance (QC/QA): Serves as a system suitability standard and for routine batch testing in pharmaceutical QC laboratories to ensure product purity.
• Regulatory Compliance & Filings: Supports the preparation of regulatory documentation (e.g., for FDA, EMA) by providing characterized impurity data for drug master files (DMFs) and investigational new drug (IND) applications.
• Stability Studies: Employed to monitor the formation of degradation products in Omeprazole under various stress conditions (e.g., heat, light, humidity).
• Research & Development: Used in academic and industrial R&D to study the degradation pathways, metabolism, and synthesis of Omeprazole and related compounds.

Basic Information

Product Name	Omeprazole Impurity 25
CAS No.	2101206-66-8
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Omeprazole Related Compound 25; Omeprazole EP Impurity I; Omeprazole USP Impurity; 5-Methoxy-2-[[(4-methoxy-3,5-dimethyl-2-pyridinyl)methyl]sulfinyl]-1H-benzimidazole Impurity; Omeprazole Degradant; Omeprazole Process Impurity; 1H-Benzimidazole, 5-methoxy-2-[[(4-methoxy-3,5-dimethyl-2-pyridinyl)methyl]sulfinyl]-, impurity
EINECS	Contact for details

Quality Control

Every batch of Omeprazole Impurity 25 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing using advanced analytical techniques such as HPLC, LC-MS, NMR, and IR spectroscopy to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results. We support compliance with ICH Q3A/B guidelines and can supply materials suitable for use under cGMP conditions.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). Due to its hygroscopic nature, the container must be kept tightly sealed in a dry environment to prevent moisture absorption. 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)	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.