Lubiprostone Related Compounds & Impurities

Lubiprostone is a ClC-2 chloride channel activator that enhances intestinal fluid secretion, used for chronic idiopathic constipation and IBS-C.

Simson Pharma Limited along with its subsidiary offices Simson Pharma Global Ltd. (UK) and Simson Pharma Global LLC (USA) is a trusted manufacturer and supplier of high-quality pharmaceutical reference standards, offering a comprehensive portfolio of Lubiprostone reference standards, pharmacopeial and non-pharmacopeial Lubiprostone impurities, related compounds, related substances, metabolites, stable isotope-labelled compounds, deuterium labelled compounds and nitrosamine (N-NO) reference standards.

These materials support pharmaceutical research and development, product development, ANDA and DMF submissions, quality control (QC), analytical method development and validation, stability studies, impurity identification, and genotoxic impurity assessment.

Our Lubiprostone-related reference standards are thoroughly characterized using advanced analytical techniques and are supplied with comprehensive Certificates of Analysis (COA) and supporting analytical data from our USFDA certified, ISO 17025 and ISO 17034 accredited Lab, to meet global regulatory expectations. EP and USP traceable reference standards can also be provided upon request, subject to availability. Simson is also a provider of EP and USP traceable standards. To ensure consistent quality and reliability, our reference standards are periodically re-tested according to established quality management procedures.

Pharmaceutical Reference Standards / Impurity Standards

Lubiprostone
Lubiprostone Related Compound 7
Lubiprostone impurity 1
7-((1R,2R)-2-(4,4-Difluoro-3-oxooctyl)-5-oxocyclopentyl)heptanoic Acid
7-((1R,2R,3R)-2-(4,4-difluoro-3-oxo-1- octyl)-3-(phenylmethoxy)-5-oxo- cyclopentyl)heptanoic Acid
7-((1R,2S)-2-(4,4-difluoro-3-oxo-1-octyl)-5-oxo-3-cyclopentenyl)heptanoic Acid
6-(6-Carboxyhexyl)-2-(1,1-difluoropentyl)2,8-dihydroxybicyclo[3.2.1]octan-7-one
1-(6-Carboxyhexyl)-8-(1,1-difluoropentyl)-8-hydroxybicyclo[3.3.0]oct-3-en-2-one
3aR,4R,5R,6aS)-2-oxo-5-((tetrahydro-2H-pyran-2-yl)oxy)hexahydro-2H-cyclopenta[b]furan-4-carbaldehyde
(3aR,4S,5R,6aS)-4-(hydroxymethyl)-5-((tetrahydro-2H-pyran-2-yl)oxy)hexahydro-2H-cyclopenta[b]furan-2-one
((+/-)-Corey Lactone Diol
Lubiprostone Impurity 1
Lubiprostone Impurity ll
Lubiprostone Hemiketal
5-Amino Lenalidomide
7-((1R,2R,3R)-2-(4,4-difluoro-3-oxooctyl)-5-oxo-3-((tetrahydro-2H-pyran-2-yl)oxy)cyclopentyl)heptanoic acid
cyclohexylmethyl 7-((2R,4aR,5R,7aR)-2-(1,1-difluoropentyl)-2-hydroxy-6-oxooctahydrocyclopenta[b]pyran-5-yl)heptanoate
(Z)-benzyl 7-((2R,4aR,5R,7aR)-2-(1,1-difluoropentyl)-2-hydroxy-6-oxooctahydrocyclopenta[b]pyran-5-yl)hept-5-enoate
7-(2-(4,4-difluoro-3-oxooctyl)-5-oxocyclopent-3-en-1-yl)heptanamide (RS)
Lubiprostone Impurity 6

Metabolites

15-Hydroxy Lubiprostone

Isotope Labelled Compounds

Lubiprostone D7
15-Hydroxy Lubiprostone-d4
15-Hydroxy Lubiprostone-D7