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SUMMITBIOANALYTICS

Testing services

Every test we run, and exactly what it tells you

Order tests individually or bundled into a panel. Each result is reported against a stated specification, with the underlying data attached — never a bare number.

Chemistry

HPLC Purity

RP-HPLC / UV

Samples are reconstituted, filtered, and separated on a C18 column with a water/acetonitrile gradient containing 0.1% TFA. Peaks are integrated across the full run and purity is reported as area-percent of total integrated peak area at the monitoring wavelength. The certificate includes the labeled chromatogram, retention times, and every impurity peak above the reporting threshold — not just a headline number.

Reports
Area-percent purity, impurity profile, chromatogram
Turnaround
3–5 business days
List price
$85 / sample
Chemistry

LC-MS Identity

LC-MS (ESI)

Liquid chromatography coupled to electrospray ionization mass spectrometry. We report the observed monoisotopic or average mass against the theoretical mass for the declared sequence, along with the observed charge-state envelope. Identity confirmation answers a question purity cannot: purity tells you how much of one thing is in the vial; identity tells you whether that thing is what the label claims.

Reports
Observed vs. theoretical mass, charge states
Turnaround
3–5 business days
List price
$95 / sample
Chemistry

Quantitation (mg/vial)

HPLC vs. reference standard

Quantitation is run against a calibration curve built from a certified reference standard. The result is reported as measured mg per vial and as percent of label claim. This is the test that catches underfilled vials — a sample can be 99% pure and still contain 30% less peptide than the label states.

Reports
Measured mass per vial vs. label claim
Turnaround
3–5 business days
List price
$120 / sample
Chemistry

Fentanyl Screen

LC-MS/MS

Targeted liquid chromatography tandem mass spectrometry screening for fentanyl and a panel of common analogs, including acetylfentanyl and carfentanil. Results are reported as detected or not detected against a stated limit of detection — never as a bare 'clean' claim. Adulteration is not something a purity number can catch: a sample can integrate at 99% area-percent and still carry a trace contaminant far below the level HPLC/UV would resolve, which is precisely the level that matters here. Screening is run on the material as received; a not-detected result describes that sample only and is not a statement about any other unit or lot.

Reports
Detected / not detected, with detection limit
Turnaround
3–5 business days
List price
$95 / sample
Microbiology

Bacterial Endotoxin

Kinetic chromogenic LAL, USP <85>

Bacterial endotoxin testing by kinetic chromogenic LAL following USP <85>. Results are reported in endotoxin units per milligram (or per vial, on request) with positive product controls to demonstrate the absence of assay interference from the sample matrix.

Reports
EU/mg or EU/vial
Turnaround
3–5 business days
List price
$110 / sample
Microbiology

Sterility Screen

Membrane filtration / rapid screen

Sterility screening for lyophilized powder and reconstituted solution. Standard compendial sterility requires a 14-day incubation; our rapid screen returns a growth/no-growth result in about ten business days for release decisions, with full compendial sterility — a longer turnaround, since the 14-day incubation runs before prep and reporting — available on request.

Reports
Growth / no growth
Turnaround
10 business days
List price
$150 / sample
Elemental

Heavy Metals

ICP-MS

Inductively coupled plasma mass spectrometry for the four elemental impurities of primary toxicological concern, following ICH Q3D principles. Results are reported in parts per million with method detection limits stated on the certificate. Extended elemental panels are available by quote.

Reports
Pb, As, Cd, Hg in ppm
Turnaround
7–10 business days
List price
$175 / sample
ChemistryComing soon

Residual Solvents

Headspace GC-MS

Headspace gas chromatography mass spectrometry for solvents retained from synthesis and lyophilization. Useful when purity looks clean but the material carries a strong odor or fails to reconstitute as expected.

Reports
Residual solvent profile, ppm
Turnaround
7–10 business days
List price
By quote
ChemistryComing soon

Water Content

Karl Fischer titration

Karl Fischer titration measures residual moisture in lyophilized material. Water content is frequently the explanation when quantitation comes back below label claim on material that is otherwise chromatographically clean.

Reports
Percent water by mass
Turnaround
3–5 business days
List price
By quote

Not sure which tests you need?

Tell us what the material is and what decision you are making with the result. We will tell you the shortest path to a defensible answer — including when a test is not worth running.