Description

Mycophenolic Acid- 13 C 17 is a stable isotope-labeled analog of the potent immunosuppressive agent Mycophenolic Acid. This compound is specifically designed for use as an internal standard in quantitative bioanalytical methods, ensuring the highest accuracy and reliability in pharmacokinetic and metabolic studies. It is an essential tool for pharmaceutical R&D, clinical laboratories, and contract research organizations (CROs) engaged in the development and monitoring of immunosuppressive therapies.

Application

• Quantitative Bioanalysis: Serves as a critical internal standard in Liquid Chromatography-Mass Spectrometry (LC-MS/MS) for the precise quantification of Mycophenolic Acid in biological matrices like plasma, serum, and urine.
• Pharmacokinetic/Pharmacodynamic (PK/PD) Studies: Enables accurate tracking of drug concentration over time to establish dosing regimens and efficacy profiles.
• Drug Metabolism and Disposition Research: Used in studies investigating the metabolic pathways, bioavailability, and clearance of Mycophenolic Acid and its prodrug, Mycophenolate Mofetil.
• Therapeutic Drug Monitoring (TDM): Facilitates the development and validation of robust clinical assays to monitor patient drug levels, optimizing therapy and minimizing toxicity.
• Method Development and Validation: A key component in establishing FDA/EMA-compliant analytical methods for new drug applications (NDAs) and generic drug submissions.
• Quality Control in Manufacturing: Can be utilized in impurity profiling and assay validation of Mycophenolic Acid active pharmaceutical ingredient (API) and finished dosage forms.

Basic Information

Product Name	Mycophenolic Acid- 13 C 17
CAS No.	1202866-92-9
Molecular Formula	C1713C17H20O6
Molecular Weight	~338.3 g/mol (exact mass varies with 13C enrichment)
Synonyms	6-(4-Hydroxy-6-methoxy-7-methyl-3-oxo-1,3-dihydro-2-benzofuran-5-yl)-4-methyl-4-hexenoic acid-13C17; MPA-13C17; Mycophenolate-13C17; Isotopically Labeled Mycophenolic Acid; [13C17]-Mycophenolic Acid; Stable Isotope Internal Standard for MPA; (E)-6-(1,3-Dihydro-4-hydroxy-6-methoxy-7-methyl-3-oxo-5-isobenzofuranyl)-4-methyl-4-hexenoic acid-13C17
EINECS	Contact for details

Quality Control

Every batch of Mycophenolic Acid- 13 C 17 is manufactured and analyzed under strict quality systems. We guarantee high chemical and isotopic purity, with comprehensive characterization by NMR, HPLC, and MS to confirm structure and isotopic enrichment. Certificates of Analysis (COA) detailing batch-specific results for assay, purity, and isotopic abundance are provided. Our production adheres to cGMP principles suitable for use in regulated bioanalytical laboratories.

Storage

Preserve in a tightly closed container, protected from light. Store at -20°C or below for long-term stability. Allow the vial to equilibrate to room temperature in a desiccator before opening to prevent condensation. The product is hygroscopic (moisture-sensitive).

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Conforms to reference standard
Identification (MS)	Conforms to expected mass spectrum
Purity (HPLC)	≥ 98.0%
Isotopic Enrichment	≥ 99 atom % 13C
Chemical Purity	≥ 95.0% (by 1H NMR)
Water Content (KF)	≤ 1.0%
Residual Solvents (GC)	Meets ICH guidelines

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