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
Net Peptide Content
HPLC vs. certified reference standard, corrected for water and counterion
Lyophilized peptide is not pure peptide by weight. It arrives as a salt: the peptide itself plus a trifluoroacetate or acetate counterion, bound water, and whatever buffer survived lyophilization. Net peptide content is typically 70–85% of gross powder mass, which means a vial holding a correct 10 mg of powder may contain closer to 8 mg of peptide. We quantify against a calibration curve built from a certified reference standard and correct for water content and counterion load, then report the net peptide mass, the gross mass, and the percent of label claim side by side. Reporting gross mass alone is the single most common way a technically accurate COA overstates what a customer received.
- Reports
- Net peptide mg/vial, gross mass, percent of label claim
- Turnaround
- 3–5 business days
- List price
- $120 / sample
Formulation
Nasal Spray Testing
RP-HPLC / UV + LC-MS, delivered-dose assay
Nasal sprays are solutions, and solutions behave differently from lyophilized powder. We report peptide concentration in mg/mL against label claim, purity by RP-HPLC with LC-MS identity confirmation, solution pH, and preservative content where one is declared. Separately, we assay the delivered dose per actuation across the bottle — first spray, mid-bottle, and last — because a formulation can be correctly concentrated and still deliver an inconsistent dose through the pump. Peptides in solution also hydrolyze over time in a way dry powder does not, so the impurity profile on a nasal spray is a statement about the material as received on that date, not a shelf-life claim.
- Reports
- Concentration, delivered dose per actuation, purity, pH
- Turnaround
- 3–5 business days
- List price
- $165 / sample
Formulation
Capsule Testing
Extraction + RP-HPLC / UV, LC-MS identity
Capsule contents are extracted from the shell and excipients, then quantified by RP-HPLC against a certified reference standard, with LC-MS confirming identity. We report measured mg per capsule against label claim and, following USP <905> principles, content uniformity across ten capsules from the same batch — the test that separates a correctly dosed batch from one where the blend was not uniform when it was filled. A single-capsule assay can look perfect while the batch varies widely, so uniformity is reported alongside the mean rather than in place of it. Excipient interference is checked with a matrix blank so filler is never counted as active.
- Reports
- mg per capsule, content uniformity, purity
- Turnaround
- 3–5 business days
- List price
- $145 / 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
PCR-based rapid sterility (compendial USP <71> on request)
Our standard sterility screen amplifies bacterial and fungal nucleic acid directly from the sample, so it detects contamination without waiting for organisms to grow. That removes the incubation step that makes conventional sterility slow, and returns a growth/no-growth result inside the same 3–5 business day window as the chemistry panels. Full compendial sterility by membrane filtration per USP <71> remains available on request: it carries a 14-day incubation that runs before prep and reporting, so it lands around three weeks, and it is the right choice when a pharmacopeial claim is specifically required. The rapid screen is a screen — it is what batch-release decisions run on, and we label it as such on the certificate rather than presenting it as compendial sterility.
- Reports
- Growth / no growth
- Turnaround
- 3–5 business days
- List price
- $165 / sample
Chemistry
Lot Conformity (Multi-Vial)
Three vials assayed independently, mean and standard deviation reported
A single-vial certificate makes a claim about a single vial. It says nothing about the vial your customer actually received, because the failure mode that matters in this market is not a bad lot — it is an inconsistent one, where fill volume drifts across a run or a blend was not homogeneous when it was dispensed. Lot conformity assays three vials drawn from the same lot as independent samples: each gets its own accession number, its own purity, net peptide content, and identity confirmation. The certificate then reports the mean and standard deviation across all three, so the spread is visible rather than averaged away. A tight standard deviation is a much stronger statement than any single purity figure, and it is the claim a vendor publishing COAs to customers actually wants to be able to make. Additional vials beyond three are quoted per vial.
- Reports
- Per-vial purity, net content and identity, plus lot mean and SD
- Turnaround
- 5 business days
- List price
- $240 / sample
Chemistry
Blend Composition
RP-HPLC / UV against per-component reference standards, LC-MS identity
Blends are now a large share of what ships in this market, and a single purity number describes them badly. A three-component blend can integrate at 99% aggregate purity — no meaningful impurities anywhere in the chromatogram — while carrying twice the intended amount of one component and half of another. Aggregate purity cannot see that; only a compositional assay can. We resolve each declared component against its own reference standard, confirm each identity by LC-MS, and report the weight-percent of every component against the declared ratio. Any component present that was not declared is reported as well. The certificate carries the full composition table alongside the aggregate purity figure, so both questions are answered on the same page.
- Reports
- Weight-percent of each declared component, per-component identity
- Turnaround
- 3–5 business days
- List price
- $195 / sample
Elemental
Heavy Metals
ICP-MS
Inductively coupled plasma mass spectrometry following ICH Q3D principles. We report the four Class 1 elemental impurities of primary toxicological concern — arsenic, cadmium, mercury, and lead — plus chromium. Chromium is not a Class 1 element, and most labs leave it off; we run it because it is the element that appears when material has been in contact with the wrong grade of stainless steel somewhere in synthesis, transfer, or filling, which makes it a useful signal about the process rather than only about the molecule. Results are reported in parts per million against stated limits, with method detection limits on the certificate and values below the limit of quantitation reported as such rather than as zero. Extended elemental panels are available by quote.
- Reports
- As, Cd, Cr, Hg, Pb 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 net peptide content comes back below label claim on material that is otherwise chromatographically clean, and it is one of the two corrections that separate net peptide mass from gross powder mass.
- Reports
- Percent water by mass
- Turnaround
- 3–5 business days
- List price
- By quote
Stability
Stability Program
Timepoint testing under controlled storage, ICH Q1A principles
A certificate describes material on the day it was tested. A stability program describes what happens to it afterwards. We retain sealed units from the lot under defined storage conditions — refrigerated, ambient, and accelerated — and re-assay purity, net peptide content, and appearance at scheduled timepoints, reporting the trend rather than a single figure. Peptides degrade by routes that a day-one certificate cannot anticipate: hydrolysis at labile bonds, oxidation of methionine and tryptophan, deamidation, aggregation in solution. Programs are built per compound and per storage condition, so pricing and timepoint schedules are quoted against the protocol. Reported stability data describes the retained units under the stated conditions and is not a shelf-life or expiry claim.
- Reports
- Purity and content trend across timepoints, degradation profile
- Turnaround
- Per protocol
- List price
- By quote