What has to be true before a batch ships
Our release specification is short, public, and applied without exception. Here is every test a lot must pass.
The four gates
Purity by HPLC-UV
Reverse-phase separation with UV detection at 214 nm. Target peak area as a percentage of total integrated peak area must be at least 98.0%.
Identity by LC-MS
Measured mass must match the monoisotopic mass calculated from the sequence. A mismatch fails the lot outright, regardless of purity.
Net content, gravimetric
Fill weight is verified against label claim so you can calculate a real concentration on reconstitution.
Documentation
The certificate is keyed to the batch number and published to the COA library before the lot is cleared for sale.
We do not grade our own homework
Every assay result we publish comes from an ISO/IEC 17025 accredited laboratory with no commercial interest in the outcome. The laboratory that tested your lot is named on its certificate.
What happens to a failing batch
It is quarantined and destroyed.
That sentence is the whole policy, but it is worth stating what it rules out. We do not blend a failing lot into a passing one to bring the average up. We do not re-test a borderline result until a favourable number appears. We do not relabel out-of-specification material as a lower grade and sell it at a discount.
A specification that bends under commercial pressure is not a specification. The cost of destroying material is what makes the number on the certificate mean anything.
Testing questions
How is purity measured?
Purity is determined by reverse-phase HPLC with UV detection, typically at 214 nm where the peptide bond absorbs. The reported figure is the target peak area as a percentage of total integrated peak area. Our release specification is ≥98.0%.
How do you confirm identity?
Identity is confirmed by LC-MS. The measured mass is compared against the expected monoisotopic mass calculated from the sequence. A batch that does not match is not released, regardless of its purity number.
Who performs the testing?
Testing is performed by independent ISO/IEC 17025 accredited laboratories — we do not self-report purity. The laboratory that tested your specific batch is named on the certificate of analysis.
Can I get the COA for the exact vial I received?
Yes. The batch number is printed on your vial label. Enter it in the COA library and you will get the certificate for that specific lot, not a representative sample.
What happens if a batch fails specification?
It is not released for sale. Out-of-specification material is quarantined and destroyed. We do not blend, re-test until pass, or downgrade failing lots.
