Mycophenolate (mycophenolate mofetil, mycophenolic acid)

Mycophenolate: immunosuppressant (IMPDH inhibitor).

Mycophenolate testing at Vanguard Laboratory: identity, purity and quantity $250 per sample, with results in 3 to 5 business days.

Structure

2D structure of Mycophenolate

Mycophenolate: 2D structure drawn from the PubChem record (CID 446541).

Compound data

CAS number

24280-93-1

Formula

C17H20O6

Molecular weight

320.34 g/mol

Type

Immunosuppressant (IMPDH inhibitor)

Structure and names

Identity: Mycophenolic acid

IUPAC name: (E)-6-(4-hydroxy-6-methoxy-7-methyl-3-oxo-1H-2-benzofuran-5-yl)-4-methylhex-4-enoic acid

How Vanguard tests Mycophenolate

Method for the $250 identity, purity and quantity test: HPLC-UV purity and assay, LC-MS identity, against a reference standard, with results in 3 to 5 business days.

The USP monographs cover identity by infrared spectroscopy, UV spectrum and HPLC retention time, assay by HPLC, and related compounds by HPLC. Full testing to the USP Mycophenolate Mofetil, Mycophenolate Sodium or Mycophenolic Acid monograph is available and quoted.

What's reported

  • Purity, as percent of total peak area
  • Quantity, against the label claim
  • Identity, reported as match or no match against the reference standard
  • With monograph testing (quoted): the monograph’s tests against its limits

Tests and prices

$250

Chromatographic purity and mg per unit by the method matched to the compound, identity against a reference standard. 1 unit.

$200

Chromatographic purity on bulk powder. 50 mg.

Add-on tests

Add-on testPrice
Identity and impurities
FTIR identity$90
CHNS elemental analysis (carbon, hydrogen, nitrogen, sulfur)$125
Chiral purity (where a chiral method exists; new methods quoted)$250
Water, solvents and salt form
Water content by Karl Fischer$60
Residual solvents$150
Counterions: chloride, acetate and TFA$70
Assay
Assay, % w/w (with raw powder purity; $250 together)+$50
Metals and conformity
Heavy metals: arsenic, cadmium, chromium, mercury and lead$150
Conformity: purity and quantity on more units from the same lot$100 per extra unit
Microbiology (injectables)
Endotoxin$210
Sterility or bioburden$150
Container closure integrity (CCI)$50
Screening
Fentanyl screen$50

10% off for 10 or more samples.

Need something else? Other tests are available on request.

Sample amount and turnaround

Purity and quantity is $250 per sample (1 unit) and raw powder purity is $200 for 50 mg, with results in 3 to 5 business days. Send the material sealed and labeled, with the label claim and the form it contains.

Salts, forms and compendial references

  • Mycophenolate Mofetil (CAS 128794-94-5)
  • Mycophenolate Sodium (CAS 37415-62-6)
  • Mycophenolic Acid (CAS 24280-93-1)
  • Tell us the salt or form the label states, so quantity is reported on the same basis.

Questions about Mycophenolate testing

Is the $250 test the same as USP monograph testing?

No. The $250 test covers identity, purity and quantity by HPLC-UV for purity and quantity and LC-MS for identity. Full testing to the USP Mycophenolate Mofetil, Mycophenolate Sodium or Mycophenolic Acid monograph is available and quoted.

Can the test tell mycophenolate mofetil from mycophenolic acid?

Yes. Mycophenolate mofetil is the morpholinoethyl ester of mycophenolic acid, so the two differ in HPLC retention time and mass by LC-MS. Free mycophenolic acid in mofetil material shows up as a related compound.

Which form should a sample be tested as?

The sample is tested and reported as the form named on the label, mofetil, sodium salt or acid. Converting between them changes the number, so the basis is stated on the report.

Does mycophenolate mofetil hydrolyze?

Yes. The ester hydrolyzes to mycophenolic acid in solution, faster at basic pH, so samples are prepared just before analysis.

Sources

https://pubchem.ncbi.nlm.nih.gov/compound/446541

Identity facts from the USP monograph header for this compound.

Order

Start an order online, or send the compound name and the tests you need for a quote.