Description

Lubiprostone CAS NO 333963-40-9 is a selective chloride channel activator used as a potent pro-secretory agent. This compound is critical for its role in treating chronic idiopathic constipation and irritable bowel syndrome with constipation (IBS-C) by increasing intestinal fluid secretion. It is an essential active pharmaceutical ingredient (API) for pharmaceutical manufacturers developing targeted gastrointestinal therapeutics. The product is supplied with a focus on high purity and reliable supply chain integrity for global pharmaceutical development and production.

Application

• Primary Active Pharmaceutical Ingredient (API) in prescription medications for chronic idiopathic constipation.
• Key component in formulated drugs for the treatment of irritable bowel syndrome with constipation (IBS-C).
• Used in clinical research and development of novel gastrointestinal therapies.
• Reference standard in analytical laboratories for quality control and method validation.
• Intermediate in the synthesis of more complex pharmaceutical compounds targeting chloride channels.
• Raw material for preclinical and pharmacological studies investigating intestinal secretion mechanisms.

Basic Information

Product Name	Lubiprostone
CAS No.	333963-40-9
Molecular Formula	C20H32F2O5
Molecular Weight	390.47 g/mol
Synonyms	RU-0211; SPI-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
EINECS	Contact for details

Quality Control

Our Lubiprostone is manufactured under strict quality management systems. Each batch is subjected to comprehensive analytical testing including HPLC for purity and assay, identification by spectroscopic methods (IR, NMR), and stringent control of related substances and residual solvents. We provide full traceability and Certificates of Analysis (COA) are available for every shipment, ensuring compliance with cGMP and ICH guidelines for pharmaceutical ingredients.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). The product is light-sensitive and should be handled under appropriate conditions to maintain stability.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference standard
Identification (HPLC)	Retention time matches reference
Assay (HPLC)	98.0% - 102.0%
Related Substances (HPLC)	Total impurities ≤ 2.0%
Any single unknown impurity	≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C
Heavy Metals	≤ 20 ppm
Loss on Drying	≤ 1.0%

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