Fexofenadine hydrochloride

Fexofenadine hydrochloride: piperidine antihistamine (second generation).

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

Structure

2D structure of Fexofenadine hydrochloride

Fexofenadine hydrochloride: 2D structure drawn from the PubChem record (CID 63002).

Compound data

CAS number

153439-40-8

Formula

C32H39NO4 · HCl

Molecular weight

538.12 g/mol

Type

Piperidine antihistamine (second generation)

Structure and names

Identity: Fexofenadine hydrochloride

IUPAC name: 2-[4-[1-hydroxy-4-[4-[hydroxy(diphenyl)methyl]piperidin-1-yl]butyl]phenyl]-2-methylpropanoic acid;hydrochloride

How Vanguard tests Fexofenadine 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, a named related compound and other organic impurities by HPLC, plus residue on ignition and water content. Full testing to the USP Fexofenadine 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

  • Fexofenadine Hydrochloride (CAS 153439-40-8)
  • Tell us the salt or form the label states, so quantity is reported on the same basis.

Questions about Fexofenadine hydrochloride 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 and LC-MS for identity. Full testing to the USP Fexofenadine Hydrochloride monograph is available and quoted.

Does fexofenadine hydrochloride contain water?

It can. USP allows anhydrous material and hydrate forms, so the monograph includes a water test and the assay is calculated on the anhydrous basis.

Can the test tell fexofenadine from terfenadine?

Yes. Fexofenadine is the carboxylic acid form of terfenadine, so the two differ in mass by LC-MS and elute at different HPLC retention times.

Sources

https://pubchem.ncbi.nlm.nih.gov/compound/63002

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.