Description

Cetilistat Impurity 1 is a designated impurity standard used in the analytical profiling and quality control of the active pharmaceutical ingredient Cetilistat. This high-purity reference material is critical for ensuring the safety, efficacy, and regulatory compliance of pharmaceutical formulations. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and routine batch testing.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the identification and quantification of related substances in Cetilistat 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 & Batch Release: Used in routine QC testing to ensure Cetilistat batches meet stringent pharmacopeial (e.g., USP, EP) or internal purity specifications.
• Stability Studies: Employed to track the formation and growth of this specific impurity under various stress conditions (heat, light, humidity) to establish product shelf-life.
• Regulatory Submissions: Provides necessary data for Drug Master Files (DMFs), Investigational New Drug (IND), and New Drug Application (NDA) submissions to agencies like the FDA and EMA.
• Research & Development: Used in R&D to understand the degradation pathways and chemistry of Cetilistat, aiding in process optimization.

Basic Information

Product Name	Cetilistat Impurity 1
CAS No.	282526-87-8
Molecular Formula	C19H15NO4
Molecular Weight	321.33 g/mol
Synonyms	(S)-2-((S)-Hexadecanoyloxy)-4-methylpentanoic acid; Cetilistat Related Compound; Cetilistat Degradant; (4S)-4-[[(1S)-2-Methyl-1-[(1-oxohexadecyl)oxy]propyl]oxy]-4-oxobutanoic Acid; Cetilistat Process Impurity; Lipase Inhibitor Impurity; ATL-962 Impurity
EINECS	Contact for details

Quality Control

Our Cetilistat Impurity 1 is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical characterization using techniques such as HPLC, GC, NMR, and MS to confirm identity and purity. We provide a comprehensive Certificate of Analysis (COA) with each shipment, detailing batch-specific results. The material is suitable for use as a pharmaceutical reference standard in compliance with 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 compound is hygroscopic (moisture-sensitive); the container must be kept tightly sealed in a dry environment to prevent absorption of moisture.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms
Identification (IR)	Conforms to reference spectrum
Assay (HPLC)	≥ 98.0%
Purity (HPLC, Area %)	≥ 99.0%
Single Unknown Impurity	≤ 0.5%
Total Impurities	≤ 1.0%
Residual Solvents (GC)	Meets ICH Q3C limits
Water Content (KF)	≤ 1.0%

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