Description

3-Acetyl-Don 13C Labeled is a stable isotope-labeled derivative of the potent immunosuppressant mycophenolic acid, specifically designed for advanced analytical applications. This compound is essential for use as an internal standard in quantitative mass spectrometry, ensuring unparalleled accuracy and reliability in pharmacokinetic and metabolic studies. It is a critical reagent for pharmaceutical R&D laboratories, clinical research organizations, and analytical service providers focused on therapeutic drug monitoring and bioanalytical method development.

Application

• Quantitative Bioanalysis: Serves as a stable isotope-labeled internal standard (SIL-IS) for the precise quantification of mycophenolic acid and its metabolites in biological matrices (e.g., plasma, serum) using LC-MS/MS.
• Pharmacokinetic/Pharmacodynamic (PK/PD) Studies: Enables accurate tracking of drug absorption, distribution, metabolism, and excretion (ADME) in clinical trials for immunosuppressive therapies.
• Therapeutic Drug Monitoring (TDM): Critical for developing and validating robust assays to monitor patient drug levels, optimizing dosage regimens for transplant recipients.
• Metabolite Identification and Profiling: Aids in the structural elucidation and quantification of drug metabolites, facilitating a deeper understanding of metabolic pathways.
• Method Development and Validation: Used as a reference standard to establish selectivity, sensitivity, linearity, and reproducibility in new analytical methods.
• Quality Control in Manufacturing: Can be employed in impurity profiling and assay validation during the production of mycophenolate mofetil and related pharmaceutical ingredients.

Basic Information

Item	Detail
Product Name	3-Acetyl-Don 13C Labeled
CAS No.	1217476-81-7
Molecular Formula	C18H1913CO6 *
Molecular Weight	~ 338.35 g/mol *
Synonyms	3-Acetylmycophenolic Acid-13C; 3-Acetyl MPA-13C; 7-(4-Hydroxy-6-methoxy-7-methyl-3-oxo-1,3-dihydroisobenzofuran-5-yl)-4-methylhept-4-enoic Acid-13C (acetyl labeled); 13C-Labeled 3-Acetyl Mycophenolic Acid; 3-Acetyl Don-13C; Isotopically Labeled Mycophenolic Acid Derivative; Stable Isotope Internal Standard for MPA
EINECS	Contact for details

* Calculated for the 13C-labeled form. Contact us for exact lot-specific data.

Quality Control

Every batch of 3-Acetyl-Don 13C Labeled is manufactured and controlled under a strict quality management system. We perform comprehensive analytical testing, including isotopic purity (by MS), chemical purity (by HPLC), and identity confirmation (by NMR and IR), to ensure it meets the exacting standards required for quantitative bioanalysis. A detailed Certificate of Analysis (COA) providing lot-specific data is supplied with each shipment.

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. This material is hygroscopic (moisture-sensitive). Keep the container tightly sealed in a dry environment. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (NMR)	Conforms to structure
Purity (HPLC)	≥ 98.0%
Isotopic Purity (MS)	≥ 99 atom % 13C
Chemical Purity	≥ 95.0%
Water Content (KF)	≤ 1.0%
Residual Solvents (GC)	Complies with ICH guidelines

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