Description

Orlistat Dihydropyranone Impurity is a key process-related impurity and degradation product associated with the anti-obesity drug Orlistat. This compound is of critical importance for pharmaceutical research and development, serving as a certified reference standard for analytical method development and validation. It is essential for quality control laboratories, analytical chemists, and regulatory affairs professionals in the pharmaceutical industry who require high-purity materials to ensure drug safety, efficacy, and compliance with stringent regulatory guidelines.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of impurities in Orlistat Active Pharmaceutical Ingredient (API) and finished dosage forms.
• Analytical Method Development: Crucial for developing, optimizing, and validating stability-indicating HPLC/UPLC methods in accordance with ICH Q2(R1) guidelines.
• Quality Control & Assurance: Used in routine batch release testing to monitor impurity profiles and ensure product consistency meets pharmacopeial specifications (e.g., USP, EP).
• Stability Studies: Employed to track the formation of degradation products under various stress conditions (heat, light, humidity) as part of forced degradation and long-term stability programs.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., ANDA, NDA) to demonstrate understanding and control of the impurity profile as per ICH Q3A/B.
• Research & Development: Supports process chemistry research to understand and minimize the formation of this impurity during the synthesis and purification of Orlistat.

Basic Information

Product Name	Orlistat Dihydropyranone Impurity
CAS No.	130676-64-1
Molecular Formula	C29H53NO5
Molecular Weight	495.74 g/mol
Synonyms	(2S)-1-[(2S,3S)-3-Hexyl-4-oxo-2-oxetanyl]methyl]-2-formamido-4-methylpentyl (2S)-2-formamido-4-methylpentanoate; Orlistat Impurity D; Orlistat Dihydropyranone; Tetrahydrolipstatin Impurity; N-Formyl-L-leucine (3S,4S)-3-hexyl-4-[(2S)-2-[[(2S)-1-[[(2S)-2-formamido-4-methylpentanoyl]oxy]-4-methylpentan-2-yl]formamido]pentyl]oxetan-2-one; Lipase Inhibitor Impurity; RO 18-0647 Impurity
EINECS	Contact for details

Quality Control

Our Orlistat Dihydropyranone Impurity is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC purity assay, identification by IR and MS, and control of related substances and residual solvents, to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is supplied with each shipment, detailing the results against predefined specifications. Our quality commitment aligns with cGMP principles and supports compliance with global pharmacopeial and ICH 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 product is hygroscopic (moisture-sensitive) and must be kept under anhydrous conditions. For long-term storage, consider storing under an inert atmosphere such as argon or nitrogen.

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)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5%
Water Content (KF)	≤ 1.0% w/w
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.