Description

Orlistat Impurity 32 is a specified impurity of the active pharmaceutical ingredient Orlistat, a lipase inhibitor used in anti-obesity medication. This compound is critical for pharmaceutical research and development, serving as a key reference standard for analytical method development, quality control, and regulatory compliance. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and contract research organizations (CROs) involved in the synthesis, purification, and quality assurance of Orlistat.

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 and validating stability-indicating HPLC, UPLC, or LC-MS methods to monitor impurity profiles.
• Quality Control & Assurance (QC/QA): Employed in routine batch testing to ensure Orlistat drug substance and products meet pharmacopeial (e.g., USP, EP) and ICH Q3A/B guidelines for impurities.
• Stability Studies: Used to track the formation and growth of this specific impurity under various stress conditions (thermal, photolytic, hydrolytic) as part of drug stability programs.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., ANDA, NDA, CMC sections) to demonstrate comprehensive impurity characterization and control.
• Process Chemistry Research: Aids in understanding and optimizing the Orlistat synthesis pathway to minimize the formation of this impurity.

Basic Information

Product Name	Orlistat Impurity 32
CAS No.	145682-69-5
Molecular Formula	C29H53NO5
Molecular Weight	495.74 g/mol
Synonyms	N-Formyl-L-leucine (3S,4S)-3-hexyl-4-[(2S)-2-hydroxytridecyl]oxetan-2-one ester; (S)-2-Formamido-4-methylpentanoic acid (3S,4S)-3-hexyl-4-[(2S)-2-hydroxytridecyl]oxetan-2-one ester; Orlistat Related Compound 32; Tetrahydrolipstatin Impurity 32; THL Impurity 32; Orlistat EP Impurity G; Orlistat USP Impurity 32
EINECS	Contact for details

Quality Control

Our Orlistat Impurity 32 is manufactured under strict quality systems and undergoes rigorous analytical testing to ensure high purity and batch-to-batch consistency suitable for use as a reference standard. Each batch is supplied with a comprehensive Certificate of Analysis (COA) detailing results for identity, purity (by HPLC), and related substances. The quality control protocols are designed to meet the stringent requirements of pharmaceutical impurity standards, aligning with ICH and relevant pharmacopeial guidelines.

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 dry conditions to prevent degradation. 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)	Total impurities ≤ 5.0% Any individual unspecified impurity ≤ 1.0%
Water Content (KF)	≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C

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