Fenofibrate

Fenofibrate: fibrate (lipid-regulating agent).

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

Structure

Fenofibrate: 2D structure drawn from the PubChem record (CID 3339).

Compound data

CAS number

49562-28-9

Formula

C₂₀H₂₁ClO₄

Molecular weight

360.83 g/mol

Type

Fibrate (lipid-regulating agent)

Structure and names

Identity: Fenofibrate

IUPAC name: propan-2-yl 2-[4-(4-chlorobenzoyl)phenoxy]-2-methylpropanoate

How Vanguard tests Fenofibrate

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, assay by HPLC, organic impurities by HPLC, residue on ignition, chloride and sulfate, melting range, acidity by titration and loss on drying. Full testing to the USP Fenofibrate 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

Fenofibrate (CAS 49562-28-9)
Fenofibric Acid
Choline Fenofibrate
Tell us the salt or form the label states, so quantity is reported on the same basis.

Questions about Fenofibrate 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 Fenofibrate monograph is available and quoted.

What is the difference between fenofibrate, fenofibric acid and choline fenofibrate?

Fenofibrate is the isopropyl ester, fenofibric acid is the free acid, and choline fenofibrate is the choline salt of the acid. Each has a different mass, so LC-MS identity shows which one is present.

Can fenofibrate break down in the sample?

The ester can hydrolyze to fenofibric acid, which appears as a separate peak in the HPLC purity profile.

Sources

https://pubchem.ncbi.nlm.nih.gov/compound/3339

Identity facts from the USP monograph header for this compound.

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