Description
Mycophenolate Mofetil – Certified Primary Standard (CAS 128794-94-5)
Mycophenolate Mofetil (MMF, CAS 128794-94-5) is the prodrug of Mycophenolic Acid (MPA), a selective IMPDH inhibitor used in transplant immunosuppression. ReChem Labs supplies MMF as a certified primary standard at 99.7 ± 0.3% purity by qNMR, with NIST/BIPM-traceable metrological documentation and full measurement uncertainty analysis.
The qNMR method provides absolute purity without dependence on secondary reference materials — making this primary standard ideal for calibrator preparation, internal standard validation, and primary calibration in TDM programs. Each lot is characterized by ¹H-qNMR with an appropriate internal standard, reverse-phase HPLC, residual solvent analysis (GC-HS), water content (KF), and LC-MS identity confirmation.
Applications include: HPLC and LC-MS/MS method validation for MPA/MMF TDM in transplant patients, calibration and QC material preparation for MPA monitoring panels, pharmacokinetics and bioavailability studies, and stability and method transfer studies in pharmaceutical R&D.
Product Specifications
| CAS Number | 128794-94-5 |
| Molecular Formula | C₁₇H₂₀O₆ |
| Purity | 99.7 ± 0.3% (qNMR) |
| Standard Type | Certified Primary Standard — NIST/BIPM-Traceable |
| Storage | 2–8°C, protect from moisture |
| Pack Sizes | 25 mg | 50 mg | 100 mg |
| Documentation | qNMR Report, COA with Uncertainty, SDS, NIST-Traceable Certificate |
Key Features
- Purity 99.7 ± 0.3% by qNMR — absolute primary determination, NIST/BIPM-traceable
- Full measurement uncertainty analysis per GUM (Guide to the Expression of Uncertainty)
- ¹H-qNMR spectrum, HPLC profile, GC-HS residual solvents, and KF moisture in COA
- Identity confirmed by LC-MS and IR spectroscopy
- Suitable for LC-MS/MS TDM calibration, method validation, and pharmacokinetics
- Same-day dispatch from Houston, TX (orders placed before 2 PM CST)
