Description

(2S,3S,5S)-5-[(n-Formyl-L-Leucyl)Oxy]-2-Hexyl-3-Hydroxyhexadecanoic Acid (Orlistat Impurity) is a defined chemical impurity used as a critical reference standard in pharmaceutical development and quality control. This compound is essential for ensuring the purity, safety, and efficacy of the anti-obesity drug Orlistat by enabling accurate identification and quantification of related substances. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method validation, stability studies, and compliance testing.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the analysis of Orlistat (Xenical®/Alli®) active pharmaceutical ingredient (API) and finished dosage forms.
• Analytical Method Development & Validation: Used to develop, calibrate, and validate HPLC, UPLC, and LC-MS methods for impurity profiling.
• Quality Control & Batch Release Testing: Critical for establishing impurity limits and ensuring batch-to-batch consistency of Orlistat API in compliance with ICH Q3A/B guidelines.
• Stability Studies & Degradation Pathway Analysis: Employed to monitor the formation of this specific impurity under various stress conditions (e.g., heat, humidity, light).
• Regulatory Submissions: Provides essential data for Drug Master Files (DMFs), Investigational New Drug (IND), and New Drug Application (NDA) submissions to agencies like the FDA and EMA.
• Pharmacopoeial Testing: Supports testing procedures as per USP, EP, or other pharmacopoeial monographs for Orlistat.

Basic Information

Product Name	(2S,3S,5S)-5-[(n-Formyl-L-Leucyl)Oxy]-2-Hexyl-3-Hydroxyhexadecanoic Acid (Orlistat Impurity)
CAS No.	130676-66-3
Molecular Formula	C29H53NO6
Molecular Weight	511.74 g/mol
Synonyms	Orlistat Impurity; Orlistat Related Compound; N-Formyl-L-leucine (3S,4S,6S)-4-hexyl-3-hydroxy-6-undecyltetrahydro-2H-pyran-2-one ester; (2S,3S,5S)-5-[(N-Formyl-L-leucyl)oxy]-2-hexyl-3-hydroxyhexadecanoic acid δ-lactone; Tetrahydrolipstatin Impurity; THL Impurity
EINECS	Contact for details

Quality Control

Every batch of this high-purity reference material is manufactured and analyzed under strict quality systems. Our products undergo rigorous quality testing to ensure compliance with industry standards, including identity confirmation by spectroscopic methods (NMR, IR, MS) and purity determination by advanced chromatographic techniques (HPLC). Certificates of Analysis (COA) are provided with each shipment, detailing batch-specific results. Production can be aligned with current Good Manufacturing Practice (cGMP) principles for pharmaceutical applications upon request.

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 product is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity ≤ 0.5% Total impurities ≤ 5.0%
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines

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