Leflunomide

Leflunomide: immunomodulator (isoxazole DHODH inhibitor prodrug).

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

Structure

2D structure of Leflunomide

Leflunomide: 2D structure drawn from the PubChem record (CID 3899).

Compound data

CAS number

75706-12-6

Formula

C12H9F3N2O2

Molecular weight

270.21 g/mol

Type

Immunomodulator (isoxazole DHODH inhibitor prodrug)

Structure and names

Identity: Leflunomide

IUPAC name: 5-methyl-N-[4-(trifluoromethyl)phenyl]-1,2-oxazole-4-carboxamide

How Vanguard tests Leflunomide

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 monograph covers identity by infrared spectroscopy and HPLC retention time, assay by HPLC, organic impurities by HPLC, residue on ignition, melting range, and loss on drying. Full testing to the USP Leflunomide 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

  • Leflunomide (CAS 75706-12-6)
  • Tell us the salt or form the label states, so quantity is reported on the same basis.

Questions about Leflunomide 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 Leflunomide monograph is available and quoted.

Does leflunomide convert to teriflunomide?

Yes. The isoxazole ring opens to teriflunomide, which has the same molecular formula. The two are told apart by HPLC retention time rather than by mass, so a sample labelled as one can be checked for the other.

What is 4-trifluoromethylaniline in leflunomide?

It is a starting material and breakdown product that is controlled as a related compound. It separates from leflunomide in the HPLC purity profile.

Sources

https://pubchem.ncbi.nlm.nih.gov/compound/3899

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.