Fluorouracil (5-FU)

Fluorouracil: pyrimidine analog antimetabolite.

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

Structure

Fluorouracil: 2D structure drawn from the PubChem record (CID 3385).

Compound data

CAS number

51-21-8

Formula

C₄H₃FN₂O₂

Molecular weight

130.08 g/mol

Type

Pyrimidine analog antimetabolite

Structure and names

Identity: Fluorouracil

IUPAC name: 5-fluoro-1H-pyrimidine-2,4-dione

How Vanguard tests Fluorouracil

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, UV spectrum and HPLC retention time, assay by HPLC, organic impurities by HPLC, related compound F and urea limits by thin-layer chromatography, residue on ignition, and loss on drying. Full testing to the USP Fluorouracil 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

Purity and quantity

$250

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

Raw powder purity

$200

Chromatographic purity on bulk powder. 50 mg.

Add-on tests

Add-on test	Price
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

Fluorouracil (CAS 51-21-8)
Tell us the salt or form the label states, so quantity is reported on the same basis.

Questions about Fluorouracil 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 Fluorouracil monograph is available and quoted.

Can the test separate fluorouracil from uracil?

Yes. Uracil is a related compound and elutes separately from fluorouracil by HPLC, and the two differ by the mass of one fluorine atom by LC-MS.

Why is fluorouracil hard to retain by HPLC?

Fluorouracil is small and very polar, so it elutes early on standard reverse-phase columns. The method uses a highly aqueous mobile phase to keep it apart from the solvent front and from polar impurities.

Why does the monograph test for urea?

Urea is a degradation product of fluorouracil in solution. It has almost no UV absorbance, so the monograph measures it with a refractive index detector.

Sources

https://pubchem.ncbi.nlm.nih.gov/compound/3385

Identity facts from the USP monograph header for this compound.

Order

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