Description

15-Hydroxy Lubiprostone is a key pharmaceutical intermediate and metabolite of the active drug substance Lubiprostone. This compound matters for its critical role in the research, development, and quality control of gastrointestinal therapeutics. It is primarily needed by pharmaceutical manufacturers, analytical laboratories, and research institutions focused on developing and validating treatments for chronic idiopathic constipation and irritable bowel syndrome.

Application

• Primary use as a reference standard and pharmaceutical intermediate in the synthesis of Lubiprostone.
• Critical component in analytical method development and validation for drug impurity profiling.
• Essential for pharmacokinetic and metabolic studies to understand drug behavior in biological systems.
• Used in quality control (QC) and quality assurance (QA) laboratories for HPLC/LC-MS system suitability testing.
• Serves as a research chemical in academic and industrial settings studying prostone analogs and chloride channel activation.
• Utilized in the preparation of calibration standards for ensuring accurate potency and impurity assays.

Basic Information

Product Name	15-Hydroxy Lubiprostone
CAS No.	475992-30-4
Molecular Formula	C20H32F2O5
Molecular Weight	390.47 g/mol
Synonyms	15-Hydroxylubiprostone; 7-[(2R,4aR,5R,7aR)-2-(1,1-Difluoropentyl)-2-hydroxy-6-oxooctahydrocyclopenta[b]pyran-5-yl]heptanoic Acid; Lubiprostone 15-Hydroxy Metabolite; AMITIZA Metabolite; RU-0211S; SPI-0211 Metabolite; (1R,2R,4aR,5R,7aR)-1-[(1S)-1,1-Difluoropentyl]-7-[(1S)-5-hydroxy-1-oxopentyl]hexahydro-2-hydroxy-5H-cyclopenta[b]pyran-5-one
EINECS	Contact for details

Quality Control

Our 15-Hydroxy Lubiprostone is manufactured under strict quality systems suitable for pharmaceutical development. Each batch undergoes rigorous analytical testing, including HPLC for purity and identity confirmation by NMR and MS, to ensure it meets exacting standards for use as a reference material. A comprehensive Certificate of Analysis (COA) detailing purity, impurities, and analytical methods is provided with every shipment.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or under refrigeration (2-8°C) as specified. Due to its sensitivity, the product should be stored under an inert atmosphere (e.g., nitrogen or argon) to prevent oxidation. Keep the container in a dry, cool, and well-ventilated area.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Single Unknown Impurity (HPLC)	≤ 0.5%
Total Impurities (HPLC)	≤ 2.0%
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.