Description

n-Desformyl n-Acetyl (S,S,R,S)-Orlistat (Orlistat Impurity) is a high-purity chemical reference standard and a specified impurity of the active pharmaceutical ingredient Orlistat. This compound is critical for analytical method development, validation, and quality control processes in pharmaceutical manufacturing. It is primarily required by research institutions, analytical laboratories, and pharmaceutical companies engaged in the development and production of anti-obesity medications to ensure product safety and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material (CRM) for the identification and quantification of impurities in Orlistat drug substance and finished dosage forms.
• Analytical Method Development: Used in developing and optimizing chromatographic methods (HPLC, UPLC) for impurity profiling of Orlistat.
• Quality Control & Assurance: Essential for routine batch testing in QC laboratories to monitor impurity levels against ICH Q3A/B guidelines.
• Regulatory Compliance & Filing: Supports regulatory submissions (e.g., to FDA, EMA) by providing impurity characterization data for drug master files (DMFs).
• Stability Studies: Employed as a marker to track degradation pathways and establish shelf-life for Orlistat-based products.
• Research & Development: Utilized in synthetic chemistry research to study the metabolism and degradation pathways of Orlistat.

Basic Information

Product Name	n-Desformyl n-Acetyl (S,S,R,S)-Orlistat (Orlistat Impurity)
CAS No.	1356841-82-1
Molecular Formula	C28H51NO5
Molecular Weight	481.71 g/mol
Synonyms	(S)-1-[(2S,3S)-3-Hexyl-4-oxo-2-oxetanyl]methyl]dodecyl (2S)-2-formamido-4-methylpentanoate Impurity; Orlistat Desformyl Impurity; Orlistat Related Compound; Tetrahydrolipstatin Impurity; THL Impurity; (S,S,R,S)-Orlistat N-Desformyl N-Acetyl Derivative; 1356841-82-1
EINECS	Contact for details

Quality Control

This high-purity impurity standard is manufactured under controlled GMP-like conditions to ensure batch-to-batch consistency and traceability. Each lot undergoes comprehensive analytical characterization using techniques including HPLC, NMR, and Mass Spectrometry to confirm identity and purity. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing purity, impurity profile, and analytical results. Our quality system is designed to support regulatory filings and meet the stringent requirements of pharmacopeial standards.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or CoA. This material is light-sensitive (store away from light) and hygroscopic (moisture-sensitive). For long-term storage, consider storing under an inert atmosphere in a cool, dry place.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (MS)	Mass spectrum conforms to structure
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any individual unknown impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 2.0%

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