How each number is produced.
A certificate is only worth what the method behind it is worth. This is what runs, and on what, for every analysis we offer.
| Analysis | What it answers | Method |
|---|---|---|
| Purity | Is the percentage of material acceptable? | LC-MS/MS |
| Net Peptide Content | Does the vial contain the mass on the label? | LC-MS/MS against a certified reference standard |
| Identity | Is it the peptide the label claims? | LC-MS molecular weight confirmation |
| pH | Is the reconstituted solution within range? | Calibrated potentiometry |
| Conformity Across Samples | Is every vial in the batch the same? | Replicate purity and content across 2 to 5 specimens |
| Sterility | Is the product free of microbial contamination? | PCR screen |
| Heavy Metals | Did anything come through from synthesis? | ICP-MS |
| Endotoxins | Is the bacterial endotoxin load within limit? | LAL, USP <85> |
| Monocyte Activation Test (MAT) | Does it contain anything that would cause a fever? | Human monocyte activation assay |
| Fentanyl Presence Analysis | Is there any fentanyl in this material? | LC-MS/MS targeted screen |
| Reconstitution Integrity Assessment (RIA) | Does the powder actually go back into solution? | USP <790> |
| Redox (Oxidation-Reduction Potential) | How prone is this material to oxidative degradation? | Oxidation-reduction potential, mV |
| Karl Fischer Titration | How much water is in the vial, and does it stay that way? | USP <921> |
Reporting
Results are reported as measured. Where a compendial limit applies, the certificate states the limit alongside the result. Where it does not, the number stands on its own without a pass or fail judgment invented for the occasion.
Endotoxins are fragments of the outer wall of certain bacteria, released when they die. They survive the sterilization that kills the bacteria themselves, and even trace amounts can cause fever and inflammation. The certificate reports the level measured, in endotoxin units per milliliter.
An unfavourable result is reported the same as any other. There is no arrangement under which a certificate is withheld or amended to suit the outcome.