Description

Orlistat Impurity 31 is a specified impurity of the active pharmaceutical ingredient Orlistat, a lipase inhibitor used in weight management. This compound is critical for pharmaceutical research and development, serving as a key reference standard for analytical method validation and quality control processes. It is primarily utilized by analytical chemists, quality assurance professionals, and researchers in the pharmaceutical industry to ensure the purity, safety, and efficacy of Orlistat-based drug products.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Orlistat API and finished dosage forms.
• Analytical Method Development & Validation: Essential for developing, optimizing, and validating chromatographic methods (e.g., HPLC, UPLC) to monitor impurity profiles.
• Quality Control & Assurance (QC/QA): Employed in routine batch testing to ensure Orlistat drug substances and products meet stringent pharmacopeial (e.g., USP, EP) and ICH regulatory specifications for impurities.
• Stability Studies: Used to track the formation and levels of this specific degradation product under various stress conditions (e.g., heat, humidity, light) as per ICH guidelines.
• Regulatory Submissions: Provides critical data for regulatory filings (e.g., ANDA, NDA) to demonstrate comprehensive impurity characterization and control strategies.
• Research on Degradation Pathways: Aids in studying the chemical stability and degradation mechanisms of Orlistat, informing better formulation strategies.

Basic Information

Product Name	Orlistat Impurity 31
CAS No.	130793-26-9
Molecular Formula	C29H53NO5
Molecular Weight	495.74 g/mol
Synonyms	N-Formyl-L-leucine (1S)-1-[[(2S,3S)-3-hexyl-4-oxo-2-oxetanyl]methyl]dodecyl ester; Orlistat Related Compound; Orlistat Impurity F; Tetrahydrolipstatin Impurity; (S)-2-Formylamino-4-methyl-pentanoic acid (S)-1-[[(2S,3S)-3-hexyl-4-oxo-2-oxetanyl]methyl]dodecyl ester; Lipase inhibitor impurity.
EINECS	Contact for details

Quality Control

Our Orlistat Impurity 31 is manufactured under strict quality systems and undergoes rigorous analytical testing to ensure identity, purity, and consistency. Each batch is supplied with a comprehensive Certificate of Analysis (COA) detailing results from tests including identification (IR, HPLC), assay (by HPLC), and related substance analysis. The quality standards are aligned with current guidelines from the International Council for Harmonisation (ICH) for impurities in new drug substances.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This compound is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation. For long-term storage, consider storing under inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Assay (HPLC)	≥ 95.0%
Purity (HPLC)	≥ 98.0%
Single Unknown Impurity	≤ 1.0%
Total Impurities	≤ 2.0%
Water Content (KF)	≤ 1.0%

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