Everolimus

Everolimus: mTOR inhibitor (macrolide).

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

Structure

Everolimus: 2D structure drawn from the PubChem record (CID 6442177).

Compound data

CAS number

159351-69-6

Formula

C₅₃H₈₃NO₁₄

Molecular weight

958.24 g/mol

Type

mTOR inhibitor (macrolide)

Structure and names

Identity: Everolimus

IUPAC name: (1R,9S,12S,15R,16E,18R,19R,21R,23S,24E,26E,28E,30S,32S,35R)-1,18-dihydroxy-12-[(2R)-1-[(1S,3R,4R)-4-(2-hydroxyethoxy)-3-methoxycyclohexyl]propan-2-yl]-19,30-dimethoxy-15,17,21,23,29,35-hexamethyl-11,36-dioxa-4-azatricyclo[30.3.1.04,9]hexatriaconta-16,24,26,28-tetraene-2,3,10,14,20-pentone

How Vanguard tests Everolimus

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 and a sirolimus limit by HPLC, an alcohol limit, residue on ignition, water content and optical rotation. Full testing to the USP Everolimus 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

Everolimus (CAS 159351-69-6)
Tell us the salt or form the label states, so quantity is reported on the same basis.

Questions about Everolimus 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 Everolimus monograph is available and quoted.

Why does the monograph check for sirolimus?

Everolimus is made from sirolimus by adding a hydroxyethyl group. Leftover sirolimus is the main process impurity, and it has a different mass and retention time.

Everolimus may contain BHT. Does that affect the result?

The monograph allows a small amount of antioxidant such as BHT to protect against oxidation. BHT elutes separately and is not counted as an everolimus impurity.

Is everolimus sensitive to light and air?

Yes. It oxidizes in air and light, so samples should stay sealed, cool and protected from light until shipping.

Sources

https://pubchem.ncbi.nlm.nih.gov/compound/6442177

Identity facts from the USP monograph header for this compound.

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