Cladribine

Cladribine: purine nucleoside analog (antimetabolite).

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

Structure

2D structure of Cladribine

Cladribine: 2D structure drawn from the PubChem record (CID 20279).

Compound data

CAS number

4291-63-8

Formula

C10H12ClN5O3

Molecular weight

285.69 g/mol

Type

Purine nucleoside analog (antimetabolite)

Structure and names

Identity: Cladribine

IUPAC name: (2R,3S,5R)-5-(6-amino-2-chloropurin-9-yl)-2-(hydroxymethyl)oxolan-3-ol

How Vanguard tests Cladribine

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 optical rotation, water and residue on ignition. Full testing to the USP Cladribine 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

  • Cladribine (CAS 4291-63-8)
  • Tell us the salt or form the label states, so quantity is reported on the same basis.

Questions about Cladribine 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 assay, with LC-MS to confirm identity. Full testing to the USP Cladribine monograph is available and quoted.

How does cladribine degrade?

The bond between the base and the sugar is weak in acid, and cladribine breaks down to 2-chloroadenine. That product separates from cladribine in the HPLC purity profile.

Is the alpha anomer of cladribine a concern?

Synthesis can form the alpha anomer as well as the intended beta form. The anomers have the same mass, so they are told apart by HPLC retention rather than LC-MS.

What forms does cladribine arrive in?

Usually as powder or as a dilute injectable solution. Give the labeled concentration so the result can be reported against it.

Sources

https://pubchem.ncbi.nlm.nih.gov/compound/20279

Identity facts from the USP monograph header for this compound.

Order

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