Mycophenolate Mofetil CRM

Price range: $580 through $1,880

Mycophenolate Mofetil certified primary standard for TDM validation, pharmacokinetics, and HPLC calibration. qNMR-certified at 99.7 ± 0.3% purity. NIST/BIPM-traceable with full measurement uncertainty analysis included.

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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)
Quantity

20 mg, 50 mg, 100mg

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