Description

(2S,3R,5S)-5-[(n-Formyl-L-Leucyl)Oxy]-2-Hexyl-3-Hydroxyhexadecanoic Acid (Orlistat Impurity) is a high-purity chemical reference standard critical for pharmaceutical research and quality control. This compound serves as a specified impurity of Orlistat, a widely used anti-obesity medication, making it essential for ensuring drug safety and regulatory compliance. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and batch release testing.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference material (CRM) for the identification and quantification of specific impurities in Orlistat active pharmaceutical ingredient (API) and finished dosage forms.
• Analytical Method Development & Validation: Serves as a critical standard for developing and validating HPLC, UPLC, or LC-MS methods to monitor impurity levels in accordance with ICH Q3A/B guidelines.
• Quality Control & Batch Release Testing: Employed in routine QC laboratories to confirm that Orlistat batches meet stringent pharmacopeial (e.g., USP, EP) and internal purity specifications.
• Stability Studies: Used to track the formation of this specific degradant during forced degradation and long-term stability studies of Orlistat.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., ANDA, NDA) to demonstrate thorough understanding and control of the drug substance impurity profile.
• Research & Development: Utilized in pharmaceutical R&D to study the metabolism, degradation pathways, and synthesis of Orlistat and related compounds.

Basic Information

Product Name	(2S,3R,5S)-5-[(n-Formyl-L-Leucyl)Oxy]-2-Hexyl-3-Hydroxyhexadecanoic Acid (Orlistat Impurity)
CAS No.	130793-28-1
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-[(2S)-2-hydroxytridecyl]-6-oxooxan-2-yl ester; (2S,3R,5S)-5-[(N-Formyl-L-leucyl)oxy]-2-hexyl-3-hydroxyhexadecanoic acid; Tetrahydrolipstatin Impurity; THL Impurity; N-Formylleucine Orlistat Ester Degradant
EINECS	Contact for details

Quality Control

This high-purity reference standard is manufactured under controlled conditions and undergoes rigorous analytical characterization to ensure identity, purity, and suitability for its intended use. Quality is assured through multiple orthogonal techniques including HPLC, NMR, and MS. A comprehensive Certificate of Analysis (COA) is supplied with each batch, detailing the results of all specification tests. Our quality system is designed to support GMP/GLP compliance for pharmaceutical applications.

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 compound is moisture-sensitive; keep the container tightly sealed in a dry environment. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unspecified impurity ≤ 1.0% Total impurities ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 2.0%

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