Bivalirudin

Bivalirudin: Direct thrombin inhibitor peptide.

Bivalirudin testing at Vanguard Laboratory: purity, quantity and identity from $250 per vial, with results in 3 to 5 business days; sterility 14 days.

Bivalirudin testing packages

Every package includes purity, quantity, identity and a solubility check. Raw powder purity is $200 for a 50 mg sample.

Level 1 Silver

$250

1 vial per sample

Level 2 Gold

$550

3 vials per sample

Level 3 Elite

$700

4 vials per sample

Tests for Bivalirudin

Each test can be added to a package or ordered on its own. Results arrive in 3 to 5 business days.

Purity and quantity

Included in every package

How pure the Bivalirudin is and how much is in the vial: purity in area percent, quantity in mg per vial against the label. Details

Conformity icon

Identity

Included in every package

Whether the sample contains Bivalirudin, compared with a reference standard. Reported as match or no match. Details

LC-MS identity

Quoted

Whether the molecular mass matches Bivalirudin, which helps catch look-alike products. Details

Heavy metals

$150

Lead, arsenic, cadmium, mercury and chromium. Included in Elite. Details

Counterion

$70

How much TFA, acetate or chloride the powder contains. Other salt forms are quoted. Details

Water content

Quoted

How much moisture the powder holds, used to work out the net content. Details

Fentanyl Screen

$50

Runs on the same vial. Included in Elite. Details

TFA Analysis

$50

Available at any level. Details

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Container Closure Integrity (CCI)

$50

Dye ingress, USP 1207. Available at any level. Details

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Conformity

$100 per extra vial

Vial-to-vial comparison within one lot. Details

Endotoxin

$210

Reported in EU per vial. Included in Gold and Elite. Details

Sterility or Bioburden

$150

Sterility for injectables: 1–10 unopened vials at the same sterility-test price. Bioburden for other forms. Included in Gold and Elite. Details

Residual Solvents

$150

Residual solvent panel. Details

API Purity

$200

Purity for API and raw powders. Details

$200 per vial

Purity and routine identity by retention time and UV spectrum against a reference standard, without quantity: no mg per vial, concentration or label-claim result. 1 vial; 3 to 5 business days. LC-MS is quoted separately. Details

BAC water icon

BAC Water

$200

Benzyl alcohol content and pH. Details

$360 per vial

Screen for semaglutide, tirzepatide and retatrutide without naming the expected peptide. Identity, amount and purity where reportable. Blind GLP-1 panel

Disulfide linkage

Quoted

Which cysteines are paired, by Orbitrap high-resolution mass spectrometry of the digested peptide.

IEX, HILIC and SEC purity

Quoted

Charge, polarity and size variants by ion-exchange, hydrophilic interaction and size-exclusion chromatography, alongside routine HPLC purity.

Conformity icon

Amino acid analysis

Quoted

Hydrolysis and amino acid analysis, to confirm composition and net peptide content.

Conformity icon

Chiral analysis

Quoted

D- and L-forms of the amino acids, to check for racemization.

Orders of ten or more samples are 10% off.

Compound data

Classification

Direct thrombin inhibitor peptide

Formula

C98H138N24O33

Molecular weight

2180.32 g/mol

CAS number

128270-60-0

Sequence, structure and names

Identity: Bivalirudin

How Vanguard tests Bivalirudin

Identity, purity and quantity are measured on the lab’s peptide method: reversed-phase HPLC on a C18 column with a water and acetonitrile gradient containing 0.1% TFA, UV detection at 214 to 220 nm, and LC-MS intact mass for identity, against a reference standard.

Testing to the USP Bivalirudin monograph is available and quoted for these tests: identity by HPLC retention time against a reference standard, LC-MS intact mass and amino acid analysis, purity and assay by HPLC with UV detection, and related compounds by HPLC.

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

Salts, forms and compendial references

  • Bivalirudin (CAS 128270-60-0)
  • Tell us the salt or form the label states, so quantity is reported on the same basis.

Sample amount and turnaround

Send 1 vial for Level 1 Silver, 3 vials for Level 2 Gold or 4 vials for Level 3 Elite; raw powder purity needs a 50 mg sample. Results arrive in 3 to 5 business days; sterility takes 14 days.

Questions about Bivalirudin testing

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

No. The $250 test covers identity, purity and quantity by HPLC and LC-MS against a reference standard. Testing to the USP Bivalirudin monograph covers the monograph tests listed on this page and is quoted.

What impurities are typical for bivalirudin?

Bivalirudin is a 20 amino acid synthetic peptide, and common impurities include deletion sequences, the Asp9 cleavage fragments and D-Phe1 epimers. The USP uses two HPLC procedures to separate them.

Why does bivalirudin degrade in solution?

It is prone to cleavage and deamidation once dissolved, especially at higher pH or temperature. Lyophilized powder is the most stable form to send.

Sources

https://pubchem.ncbi.nlm.nih.gov/compound/16129704

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.