Description

Orlistat Impurity 23 is a specified impurity associated with 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 development, validation, and quality control processes. It is essential for manufacturers and analytical laboratories focused on ensuring the purity, safety, and regulatory compliance of Orlistat-based drug products.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of Orlistat Impurity 23 in drug substances and products.
• Analytical Method Development: Crucial for developing and validating stability-indicating HPLC/UPLC methods for Orlistat and related compounds.
• Quality Control & Assurance: Used in routine QC testing to monitor impurity profiles and ensure batch-to-batch consistency of Orlistat API.
• Regulatory Compliance & Filing: Supports the preparation of regulatory documentation (e.g., for FDA, EMA) by providing impurity characterization data.
• Stability Studies: Employed to track the formation of this specific degradation product under various stress conditions.
• Research & Development: Used in synthetic chemistry research to study the degradation pathways and metabolism of Orlistat.

Basic Information

Product Name	Orlistat Impurity 23
CAS No.	1620409-37-1
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Orlistat Related Compound 23; Orlistat EP Impurity J; Orlistat USP Impurity; (2S)-1-[(2S,3S)-3-Hexyl-4-oxo-2-oxetanyl]methyl]dodecyl (2S)-2-formamido-4-methylpentanoate; N-Formyl-L-leucine (3S,4S)-3-hexyl-4-[(1S)-1-hydroxytridecyl]oxetan-2-one ester impurity; Tetrahydrolipstatin Impurity 23
EINECS	Contact for details

Quality Control

Our Orlistat Impurity 23 is manufactured under strict quality systems suitable for use as a reference standard. Each batch undergoes comprehensive analytical characterization using advanced techniques such as HPLC, GC, MS, and NMR to confirm identity and purity. A detailed Certificate of Analysis (COA) is provided with each shipment, containing batch-specific data on purity, impurities, and analytical results. Our quality commitment aligns with the standards required for pharmaceutical research and regulatory submissions.

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 material is hygroscopic (moisture-sensitive) and must be kept under inert conditions or in a desiccator to prevent degradation. For long-term storage, consider storing at 2-8°C.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
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 guidelines
Water Content (KF)	≤ 5.0%

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