Argatroban

Argatroban: direct thrombin inhibitor (arginine derivative).

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

Structure

Argatroban: 2D structure drawn from the PubChem record (CID 92721).

Compound data

CAS number

141396-28-3

Formula

C₂₃H₃₆N₆O₅S · H₂O

Molecular weight

526.65 g/mol

Type

Direct thrombin inhibitor (arginine derivative)

Structure and names

Identity: Argatroban monohydrate

IUPAC name: (2R,4R)-1-[(2S)-5-(diaminomethylideneamino)-2-[(3-methyl-1,2,3,4-tetrahydroquinolin-8-yl)sulfonylamino]pentanoyl]-4-methylpiperidine-2-carboxylic acid;hydrate

How Vanguard tests Argatroban

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, related compound C and stereoisomers by HPLC, and residue on ignition, water, bacterial endotoxins and microbial enumeration. Full testing to the USP Argatroban 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

Argatroban (CAS 141396-28-3)
Tell us the salt or form the label states, so quantity is reported on the same basis.

Questions about Argatroban testing

Is the $250 test the same as USP monograph testing?

No. The $250 test covers identity, purity and quantity by HPLC with UV detection for purity and assay, and LC-MS for identity. Full testing to the USP Argatroban monograph is available and quoted.

Why does argatroban show two peaks?

Argatroban is a mixture of two diastereomers that differ at one carbon in the tetrahydroquinoline ring. They separate on HPLC, and the result reports both the total and their ratio.

Does the hydrate form matter?

The USP material is the monohydrate, which is slightly heavier than the anhydrous form. Results are reported on the basis you name.

Sources

https://pubchem.ncbi.nlm.nih.gov/compound/92721

Identity facts from the USP monograph header for this compound.

Order

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