Description

Megestrol Acetate-D3 is a deuterium-labeled analog of the synthetic progestin megestrol acetate, serving as a critical internal standard for precise analytical quantification. This high-purity, stable isotope-labeled compound is essential for ensuring accuracy and reliability in sensitive mass spectrometry-based assays. It is primarily utilized by pharmaceutical R&D laboratories, clinical research organizations, and analytical testing facilities engaged in pharmacokinetic studies, drug metabolism research, and bioanalytical method development.

Application

• Internal Standard for LC-MS/MS: Primary application as a quantitative reference standard in liquid chromatography-tandem mass spectrometry for bioanalysis.
• Pharmacokinetic and Metabolism Studies: Enables accurate tracking and measurement of megestrol acetate and its metabolites in biological matrices (plasma, serum, urine).
• Bioanalytical Method Development and Validation: Critical for developing, optimizing, and validating robust analytical methods in compliance with regulatory guidelines (FDA, EMA).
• Clinical Research and Therapeutic Drug Monitoring (TDM): Supports studies investigating drug efficacy, safety profiles, and dose optimization.
• Pharmaceutical Quality Control: Used in impurity profiling and stability-indicating assays for drug substance and product analysis.
• Reference Material for Certified Standards: Serves as a key component in the preparation of certified reference materials (CRMs) for calibration.

Basic Information

Product Name	Megestrol Acetate-D3
CAS No.	162462-72-8
Molecular Formula	C24H29D3O4
Molecular Weight	387.52 g/mol (approx.)
Synonyms	17α-Acetoxy-6-methylpregna-4,6-diene-3,20-dione-d3; 6-Methyl-6-dehydro-17α-acetoxyprogesterone-d3; 6-Methyl-6-dehydro-17α-hydroxyprogesterone acetate-d3; Megestrol Acetate (methyl-d3); [2H3]-Megestrol Acetate; Deuterated Megestrol Acetate; NSC-71423-d3
EINECS	Contact for details

Quality Control

Our Megestrol Acetate-D3 is manufactured under strict quality systems to ensure exceptional isotopic purity and chemical integrity, suitable for the most demanding analytical applications. Each batch is supported by a comprehensive Certificate of Analysis (COA) detailing critical parameters including isotopic enrichment (D3), chemical purity by HPLC, and confirmation of structure. We adhere to relevant industry standards for high-purity reference materials.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or COA. Keep the container in a dry, cool, and well-ventilated area. For long-term storage, consider storing under inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white crystalline powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 98.0%
Isotopic Purity (D3)	≥ 98.0 atom % D
Chemical Purity	≥ 95.0%
Water Content (KF)	≤ 0.5%
Residue on Ignition	≤ 0.1%

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