Regorafenib

Regorafenib: kinase inhibitor (multikinase, bi-aryl urea).

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

Structure

Regorafenib: 2D structure drawn from the PubChem record (CID 11167602).

Compound data

CAS number

755037-03-7

Formula

C₂₁H₁₅ClF₄N₄O₃

Molecular weight

482.82 g/mol

Type

Kinase inhibitor (multikinase, bi-aryl urea)

Structure and names

Identity: Regorafenib (anhydrous)

IUPAC name: 4-[4-[[4-chloro-3-(trifluoromethyl)phenyl]carbamoylamino]-3-fluorophenoxy]-N-methylpyridine-2-carboxamide

How Vanguard tests Regorafenib

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 and a related compound A limit by HPLC, and water content. Full testing to the USP Regorafenib 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

Regorafenib (CAS 755037-03-7; monohydrate CAS 1019206-88-2)
Tell us the salt or form the label states, so quantity is reported on the same basis.

Questions about Regorafenib 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 Regorafenib monograph is available and quoted.

Is regorafenib tested as the monohydrate?

USP regorafenib can be the monohydrate, and the monograph checks water content against the monohydrate range. The assay basis, anhydrous or as-is, is stated on the report.

Can the test tell regorafenib from sorafenib?

Yes. Regorafenib has one more fluorine atom than sorafenib, so the two differ in mass by LC-MS and separate by HPLC. The USP monograph uses sorafenib as a reference material for this reason.

Sources

https://pubchem.ncbi.nlm.nih.gov/compound/11167602

Identity facts from the USP monograph header for this compound.

Order

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