Description

Orlistat Related Compound D is a high-purity chemical reference standard, essential for analytical and research purposes. This compound is critical for ensuring the quality, safety, and efficacy of pharmaceutical products by serving as a key impurity marker. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and quality control testing of Orlistat, a widely used anti-obesity medication.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference material 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 ensure specificity, accuracy, and precision.
• Quality Control & Assurance (QC/QA): Employed in routine batch release testing to monitor impurity levels and ensure compliance with pharmacopeial specifications (e.g., USP, EP).
• Stability Studies: Acts as a marker compound in forced degradation and long-term stability studies to understand the degradation pathways of Orlistat.
• Regulatory Submissions: Provides essential data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Research & Development: Utilized in metabolic and pharmacokinetic studies to investigate the behavior and fate of related substances.

Basic Information

Product Name	Orlistat Related Compound D
CAS No.	130793-27-0
Molecular Formula	C29H53NO5
Molecular Weight	495.74 g/mol
Synonyms	N-Formyl-L-leucine (1S)-1-[[(2S,3S)-3-hexyl-4-oxo-2-oxetanyl]methyl]dodecyl ester; Orlistat Impurity D; Orlistat EP Impurity D; Tetrahydrolipstatin Related Compound D; THL Related Compound D; (S)-2-Formylamino-4-methyl-pentanoic acid (1S)-1-[[(2S,3S)-3-hexyl-4-oxo-2-oxetanyl]methyl]dodecyl ester; Lipstatin Impurity
EINECS	Contact for details

Quality Control

Our Orlistat Related Compound D is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity, identity confirmation by IR and MS, and control of residual solvents and moisture. We provide a comprehensive Certificate of Analysis (COA) with each shipment, detailing all test results against stringent in-house specifications aligned with ICH guidelines. The product is suitable for use as a pharmaceutical reference standard.

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 after opening to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white powder
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 individual unspecified 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.