Description

5-Hydroxy Lansoprazole Potassium Salt is a key pharmaceutical intermediate and impurity standard used in the development and quality control of proton pump inhibitor medications. This compound matters for its critical role in ensuring the purity, safety, and efficacy of related active pharmaceutical ingredients (APIs) during manufacturing and regulatory submission processes. It is primarily needed by pharmaceutical R&D laboratories, quality assurance/quality control (QA/QC) departments, and manufacturers of fine chemicals and reference standards.

Application

• Pharmaceutical Impurity Standard: Serves as a certified reference material (CRM) for the identification and quantification of related substances in Lansoprazole and its derivative drug products.
• Analytical Research: Used in method development and validation for HPLC, LC-MS, and other chromatographic techniques within pharmaceutical analysis.
• Process Chemistry: Acts as an intermediate or a marker in the synthesis and process optimization of advanced proton pump inhibitors.
• Metabolite Studies: Employed in pharmacokinetic and drug metabolism research to study the metabolic pathways of Lansoprazole.
• Regulatory Compliance: Essential for preparing documentation and samples for regulatory filings (e.g., FDA, EMA) to demonstrate control over potential impurities.

Basic Information

Product Name	5-Hydroxy Lansoprazole Potassium Salt
CAS No.	1329613-29-7
Molecular Formula	C16H13F3KN3O3S
Molecular Weight	423.45 g/mol
Synonyms	5-Hydroxylansoprazole Potassium Salt; Lansoprazole 5-Hydroxy Impurity Potassium Salt; Potassium 2-[[[3-methyl-4-(2,2,2-trifluoroethoxy)pyridin-2-yl]methyl]sulfinyl]-5-hydroxy-1H-benzimidazol-1-ide; 5-OH Lansoprazole K Salt; 5-Hydroxy Lansoprazole K Salt; 5-Hydroxy Lansoprazole Potassium; 5-Hydroxy Lansoprazole Related Compound Potassium Salt
EINECS	Contact for details

Quality Control

Our 5-Hydroxy Lansoprazole Potassium Salt is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing to ensure high purity and consistency, meeting the stringent requirements for pharmaceutical reference standards and intermediates. A comprehensive Certificate of Analysis (COA) detailing identity, purity, and impurity profiles by validated methods (e.g., HPLC, NMR) is provided with every shipment.

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 (moisture-sensitive) nature, the container must be kept tightly sealed in a dry environment to prevent degradation. For long-term storage, consider desiccants or inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Assay (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.