Description

Orlistat-D3 is a deuterium-labeled analog of the active pharmaceutical ingredient Orlistat, a potent and specific inhibitor of gastrointestinal lipases. This stable isotope-labeled compound is an essential reference standard and internal standard for quantitative analysis in pharmaceutical research and development. It is primarily utilized by analytical chemists and researchers in pharmaceutical companies, contract research organizations (CROs), and academic institutions for applications requiring high specificity and accuracy, such as pharmacokinetic studies and bioanalytical method validation.

Application

• Bioanalytical Method Development and Validation: Serves as a critical internal standard in Liquid Chromatography-Mass Spectrometry (LC-MS/MS) for the accurate quantification of Orlistat in biological matrices like plasma and serum.
• Pharmacokinetic and Metabolism Studies: Used as a tracer to study the absorption, distribution, metabolism, and excretion (ADME) profile of Orlistat in preclinical and clinical research.
• Drug Impurity Profiling and Stability Testing: Acts as a reference standard to identify and quantify potential deuterated impurities or degradation products in drug substance and product analysis.
• Isotope Dilution Mass Spectrometry (IDMS): Employed in high-precision quantitative assays to improve accuracy and correct for analyte loss during sample preparation.
• Clinical Research Support: Essential for ensuring data integrity and regulatory compliance in bioequivalence studies and other clinical trials involving Orlistat.

Basic Information

Product Name	Orlistat-D3
CAS No.	2738374-25-7
Molecular Formula	C29H50D3NO5
Molecular Weight	~ 500.7 g/mol
Synonyms	Orlistat-d3; Tetrahydro-2(S)-[(2S,3S)-3-hexyl-4-oxo-2-oxetanyl]methyl]-d3-1H-3-isoindolecarboxylic acid 1,3-dihexyl ester; (S)-1-[(2S,3S)-3-Hexyl-4-oxo-2-oxetanyl]methyl-d3-dodecyl 2-formamido-4-methyl-pentanoate; Deuterated Orlistat; Orlistat Internal Standard; Lipase Inhibitor-d3.
EINECS	Contact for details

Quality Control

Every batch of Orlistat-D3 is manufactured and analyzed under strict quality management systems. The product undergoes rigorous testing, including advanced spectroscopic and chromatographic methods, to ensure high chemical purity, isotopic enrichment, and structural identity. A comprehensive Certificate of Analysis (COA) detailing batch-specific results for assay, isotopic purity, and related substances is provided with each shipment to support your regulatory and research requirements.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C (59-77°F). The product is hygroscopic (moisture-sensitive) and should be kept in a dry environment. For long-term storage, consider storing under inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (MS)	Conforms to structure
Purity (HPLC)	≥ 98.0%
Isotopic Purity (MS)	≥ 98.0 atom % D
Chemical Purity (NMR)	Conforms
Water Content (KF)	≤ 0.5%
Residual Solvents (GC)	Complies with ICH guidelines

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