Description

Orlistat Dimer Impurity is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and efficacy of the active pharmaceutical ingredient (API) Orlistat, a widely used anti-obesity medication. Pharmaceutical manufacturers and analytical laboratories require this impurity standard for method development, validation, and routine quality control testing to comply with stringent regulatory guidelines from agencies like the FDA and EMA.

Application

• Pharmaceutical Impurity Profiling and Characterization: Used as a certified reference material to identify and quantify the dimer impurity in Orlistat API and finished drug products.
• Analytical Method Development and Validation: Essential for developing, optimizing, and validating chromatographic methods (e.g., HPLC, UPLC) to separate and analyze process-related impurities.
• Stability Studies and Forced Degradation Testing: Employed to monitor the formation of degradation products under various stress conditions to establish product shelf-life.
• Quality Control and Batch Release Testing: Serves as a system suitability standard and for setting specification limits in the quality control of Orlistat manufacturing.
• Regulatory Compliance and Documentation: Supports regulatory filings (e.g., DMF, CMC sections) by providing data on impurity identification and control strategies.
• Research and Development: Used in R&D laboratories to study the chemical behavior, formation pathways, and mitigation strategies for this specific dimer impurity.

Basic Information

Product Name	Orlistat Dimer Impurity
CAS No.	881900-54-5
Molecular Formula	C66H100N2O5
Molecular Weight	1001.5 g/mol
Synonyms	Orlistat Dimer; Orlistat Related Compound D; Tetrahydrolipstatin Dimer; (2S)-1-[(2S,3S)-3-Hexyl-4-oxo-2-oxetanyl]methyl-2-decyl-3-heptyl-4-[[(2S,3S)-3-hexyl-4-oxo-2-oxetanyl]methyl]-1H-pyrrole-2,5-dione; N-Formyl-L-leucine (1S,2S,5S,7S,10S,11S,14S,15S)-5-Benzyl-14-(1-hydroxy-1-methylethyl)-2,8,8,11,15-pentamethyl-4,7,10,14-tetraoxo-3,17-dioxabicyclo[13.3.1]nonadec-13-yl Ester Impurity; Lipase Inhibitor Dimer Impurity
EINECS	Contact for details

Quality Control

Every batch of Orlistat Dimer Impurity CAS NO 881900-54-5 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced analytical techniques such as HPLC, GC, NMR, and MS to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment, supporting your regulatory and quality assurance requirements.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, ideally between 15-25°C (59-77°F), in a dry environment. For long-term storage, consider storing desiccated at 2-8°C. Handle the material under an inert atmosphere if necessary to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unspecified impurity ≤ 1.0% Total impurities ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 1.0% w/w

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