Rivaroxaban

Rivaroxaban: anticoagulant (factor Xa inhibitor).

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

Structure

2D structure of Rivaroxaban

Rivaroxaban: 2D structure drawn from the PubChem record (CID 9875401).

Compound data

CAS number

366789-02-8

Formula

C19H18ClN3O5S

Molecular weight

435.88 g/mol

Type

Anticoagulant (factor Xa inhibitor)

Structure and names

Identity: Rivaroxaban

IUPAC name: 5-chloro-N-[[(5S)-2-oxo-3-[4-(3-oxomorpholin-4-yl)phenyl]-1,3-oxazolidin-5-yl]methyl]thiophene-2-carboxamide

How Vanguard tests Rivaroxaban

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 enantiomeric purity by HPLC, residue on ignition, and water content. Full testing to the USP Rivaroxaban 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

  • Rivaroxaban (CAS 366789-02-8)
  • Tell us the salt or form the label states, so quantity is reported on the same basis.

Questions about Rivaroxaban 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 Rivaroxaban monograph is available and quoted.

Is rivaroxaban a single enantiomer?

Rivaroxaban is the S-enantiomer, and the R-enantiomer is a possible impurity. They have the same mass, so a chiral method is needed to measure it, which is quoted separately.

Why is sample prep important for rivaroxaban?

Rivaroxaban has very low water solubility, so it is dissolved in organic solvent before HPLC. Incomplete dissolution can make a sample read low.

Sources

https://pubchem.ncbi.nlm.nih.gov/compound/9875401

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.