Description

5-Hydroxy Omeprazole is a key pharmaceutical intermediate and metabolite of the widely used proton pump inhibitor, Omeprazole. This compound is critical for research and development in the pharmaceutical industry, particularly for metabolic studies, impurity profiling, and the synthesis of novel therapeutic agents. It is primarily utilized by pharmaceutical manufacturers, contract research organizations (CROs), and academic institutions engaged in advanced drug development and analytical chemistry.

Application

• Pharmaceutical Intermediate: Serves as a crucial building block in the synthesis of Omeprazole and related proton pump inhibitor analogs.
• Metabolite Reference Standard: Used as an analytical standard in pharmacokinetic and bioequivalence studies to quantify the 5-hydroxy metabolite in biological matrices.
• Impurity Profiling: Essential for the identification and quantification of related substances in Omeprazole Active Pharmaceutical Ingredient (API) to ensure product purity and compliance with pharmacopeial standards (e.g., USP, EP).
• Research & Development: Employed in medicinal chemistry research for the design and development of new gastroesophageal reflux disease (GERD) treatments.
• Quality Control Laboratories: Used as a certified reference material in HPLC and LC-MS methods for the quality assurance of Omeprazole-based drug products.

Basic Information

Product Name	5-Hydroxy Omeprazole
CAS No.	92340-57-3
Molecular Formula	C17H19N3O4S
Molecular Weight	361.42 g/mol
Synonyms	5-Hydroxyomeprazole; Omeprazole 5-Hydroxy Metabolite; Omeprazole Sulfone (common misnomer, verify context); 6-Methoxy-2-[[(4-methoxy-3,5-dimethyl-2-pyridinyl)methyl]sulfinyl]-1H-benzimidazol-5-ol; H 168/68 5-OH; 5-OH Omeprazole
EINECS	Contact for details

Quality Control

Our 5-Hydroxy Omeprazole is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity, identity confirmation by IR and MS, and residual solvent analysis, to ensure it meets high-purity standards suitable for pharmaceutical research. A detailed Certificate of Analysis (COA) is provided with every shipment, confirming compliance with specified parameters.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This product is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

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