Tests and methods

Six questions. Six instruments. One report.

Each test answers one thing a label can't. The method and detection limit are printed on every result, so you can compare our numbers with anyone else's.

Test	What it answers	Method	Reported as
Identity	Is this molecule the peptide on the label — not a cheaper analog with a similar name?	LC-MS/MS Shimadzu triple quadrupole	observed m/z, charge state, calculated mass vs expected
Purity	How much of what's in the vial is that peptide, versus truncated chains, deletions and leftover synthesis reagents?	HPLC-UV / DAD 214 nm, gradient	main peak % area, with the chromatogram
Content	Does a "10 mg" vial contain 10 mg?	Gravimetric calibrated balance, tare and gross	mg found vs mg on label, as %
Endotoxin	Is there bacterial endotoxin — the pyrogen that causes fever and reactions — in the vial?	LAL kinetic chromogenic	not detected at 0.01 EU/mL, or the value found
Microbial screen	Is there bacterial, fungal or viral DNA/RNA in the vial?	PCR per target panel	detected / not detected, per target
Fentanyl	Is there fentanyl or a fentanyl analog present?	LC-MS/MS targeted	not detected at 0.5 ng/mL, or the value found

Identity, purity and content are included in every test. Endotoxin, the microbial screen and fentanyl are add-ons. How each test works, and why two labs can disagree.

IDIdentityIs it actually the peptide on the label?LC-MS/MS · Shimadzu triple quadrupole IDPurityHow much of the powder is the peptide — and what is the rest?HPLC-UV / DAD at 214 nm IDContentDoes a "10 mg" vial hold 10 mg?Gravimetric · calibrated analytical balance IDEndotoxinIs there bacterial endotoxin in the vial?LAL · kinetic chromogenic IDMicrobial screenIs there bacterial, fungal or viral material in the vial?PCR · bacterial, fungal, viral targets IDFentanylIs there fentanyl, or a fentanyl analog, in the vial?LC-MS/MS · targeted MRM