Bendamustine hydrochloride

Bendamustine hydrochloride: alkylating agent (nitrogen mustard).

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

Structure

2D structure of Bendamustine hydrochloride

Bendamustine hydrochloride: 2D structure drawn from the PubChem record (CID 77082).

Compound data

CAS number

3543-75-7

Formula

C16H21Cl2N3O2 · HCl

Molecular weight

394.72 g/mol

Type

Alkylating agent (nitrogen mustard)

Structure and names

Identity: Bendamustine hydrochloride

IUPAC name: 4-[5-[bis(2-chloroethyl)amino]-1-methylbenzimidazol-2-yl]butanoic acid;hydrochloride

How Vanguard tests Bendamustine hydrochloride

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, HPLC retention time and a chloride test, assay by HPLC, organic impurities by HPLC, residue on ignition, water content, bacterial endotoxins, microbial enumeration and tests for specified microorganisms. Full testing to the USP Bendamustine Hydrochloride 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

  • Bendamustine Hydrochloride (CAS 3543-75-7)
  • Tell us the salt or form the label states, so quantity is reported on the same basis.

Questions about Bendamustine hydrochloride 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 Bendamustine Hydrochloride monograph is available and quoted.

Why is bendamustine sensitive to moisture?

Its chloroethyl groups hydrolyze in water, forming monohydroxy and dihydroxy bendamustine. These breakdown products show in the purity profile, so samples should be kept dry and solutions tested promptly.

What form does bendamustine usually arrive in?

Usually a powder, a lyophilized vial or a concentrated solution. For vials, tell us the labeled amount per vial so quantity can be compared with it.

Sources

https://pubchem.ncbi.nlm.nih.gov/compound/77082

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.