Quality control

Every lot is tested, then tested again

In-house release testing establishes that a lot meets specification. Independent third party analysis confirms it. Both sets of data are tied to the lot number printed on the vial.

  • Purity — RP-HPLC

    Method
    C18 reversed phase, acetonitrile/water gradient, UV 214 nm
    Reported as
    Main-peak area percentage against total integrated area
  • Identity — ESI-MS

    Method
    Electrospray ionisation, charge-state deconvolution
    Reported as
    Observed molecular mass versus theoretical mass for the sequence
  • Measured content

    Method
    Quantitative HPLC against a calibrated reference
    Reported as
    Actual peptide mass per vial, independent of nominal fill weight
  • Bacterial endotoxin

    Method
    Limulus amebocyte lysate (LAL)
    Reported as
    Endotoxin units per milligram, specification < 0.25 EU/mg
  • Residual solvent & TFA

    Method
    Headspace GC and ion chromatography
    Reported as
    Residual acetonitrile and trifluoroacetate carried from purification
  • Water content

    Method
    Karl Fischer titration
    Reported as
    Residual moisture in the lyophilized cake, specification < 5%

Two-stage release

A lot is first assayed in our own laboratory against its release specification. Nothing progresses to fill until purity, identity and content are within limits. After fill, a sample from the finished vials is submitted to an independent analytical laboratory that has no involvement in the synthesis.

Only when both sets of results agree is the lot released to inventory. Where they disagree, the lot is quarantined and investigated rather than reworked into stock.

What a purity percentage does and does not tell you

The purity figure on a certificate is a relative UV peak-area measurement. It states what share of UV-absorbing material at 214 nm is the target sequence. It does not account for water, counter-ion mass, or impurities that do not absorb at that wavelength.

This is why we report measured content alongside purity. Content answers the question that actually matters for quantitative work: how much target peptide is in this vial. Read them together, and use the content figure when calculating molar concentration.

Retained samples and re-testing

A retained sample from every lot is held under specification storage conditions after release. If a purity or identity question is raised later, we can re-assay the original material rather than infer from a different lot.

Raw chromatograms and mass spectra for any released lot are available to purchasers on request through our laboratory support team.

Out-of-specification handling

Material failing any release parameter does not enter inventory. Investigations trace back through the synthesis and purification record for that lot, and where a root cause affects other lots, those are quarantined for re-testing as well.

Certificates of analysis

Released lot reports, with measured content, purity and independent verification keys.