Description

Lubiprostone CAS NO 136790-76-6 is a selective chloride channel activator used as a potent gastrointestinal agent. This compound is critical for the development and manufacturing of prescription pharmaceuticals targeting chronic idiopathic constipation and irritable bowel syndrome with constipation (IBS-C). It is primarily required by pharmaceutical manufacturers, advanced research institutions, and contract development and manufacturing organizations (CDMOs) engaged in the production of gastrointestinal therapeutics.

Application

• Active Pharmaceutical Ingredient (API) in prescription medications for chronic idiopathic constipation.
• Key component in the formulation of drugs for irritable bowel syndrome with constipation (IBS-C).
• Reference standard for analytical method development and quality control in pharmaceutical laboratories.
• Intermediate in advanced research on chloride channel function and gastrointestinal pharmacology.
• Starting material for the synthesis of novel prostone analogs in drug discovery programs.
• Raw material for clinical trial material (CTM) and commercial drug product manufacturing.

Basic Information

Product Name	Lubiprostone
CAS No.	136790-76-6
Molecular Formula	C20H32F2O5
Molecular Weight	390.47 g/mol
Synonyms	SPI-0211; RU-0211; Amitiza (brand name); (-)-7-[(2R,4aR,5R,7aR)-2-(1,1-Difluoropentyl)-2-hydroxy-6-oxooctahydrocyclopenta[b]pyran-5-yl]heptanoic Acid; 7-[(2R,4aR,5R,7aR)-2-(1,1-Difluoropentyl)-2-hydroxy-6-oxooctahydro-1H-cyclopenta[b]pyran-5-yl]heptanoic Acid; Prostone analog; Chloride channel activator 1
EINECS	Contact for details

Quality Control

Our Lubiprostone is manufactured under strict quality management systems to ensure it meets the stringent requirements for pharmaceutical actives. Each batch is tested against comprehensive specifications, including identity, purity, and impurity profiles, utilizing advanced analytical techniques like HPLC and GC. A detailed Certificate of Analysis (COA) is provided with every shipment to guarantee traceability, consistency, and compliance with cGMP guidelines and relevant pharmacopeial standards.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C) or as specified on the label. This material is hygroscopic (moisture-sensitive) and must be kept under dry conditions to maintain stability and potency.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	98.0% - 102.0%
Related Substances (HPLC)	Individual impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
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.