Sorafenib tosylate

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

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

Structure

Sorafenib tosylate: 2D structure drawn from the PubChem record (CID 406563).

Compound data

CAS number

475207-59-1

Formula

C₂₁H₁₆ClF₃N₄O₃ · C₇H₈O₃S

Molecular weight

637.03 g/mol

Type

Kinase inhibitor (multikinase, bi-aryl urea)

Structure and names

Identity: Sorafenib tosylate

IUPAC name: 4-[4-[[4-chloro-3-(trifluoromethyl)phenyl]carbamoylamino]phenoxy]-N-methylpyridine-2-carboxamide;4-methylbenzenesulfonic acid

How Vanguard tests Sorafenib tosylate

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, and water content. Full testing to the USP Sorafenib or Sorafenib Tosylate 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

Sorafenib (free base, CAS 284461-73-0)
Sorafenib Tosylate (CAS 475207-59-1)
Tell us the salt or form the label states, so quantity is reported on the same basis.

Questions about Sorafenib tosylate 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 Sorafenib or Sorafenib Tosylate monograph is available and quoted.

Is the result given as sorafenib or sorafenib tosylate?

Raw material is normally the tosylate salt, and the free base is about 73 percent of the salt weight. The report states whether the quantity is expressed as the salt or as sorafenib.

Can the test tell sorafenib from regorafenib?

Yes. Regorafenib carries one extra fluorine atom, so the two differ in mass by LC-MS and separate by HPLC.

Sources

https://pubchem.ncbi.nlm.nih.gov/compound/406563

Identity facts from the USP monograph header for this compound.

Order

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