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Certificates

The laboratory

The laboratory

A manufacturer of lyophilised research peptides, organised around one quality system.

Provisional

Provisional content. The laboratory's story and organisation are described in outline and will be replaced with the full account.

Why the laboratory exists

Lyotek was set up to make one thing well: lyophilised research peptides whose contents can be verified. The founders had spent long enough buying material sold as research-grade with nothing behind it, no lot record, no release test, no way to tell one vial from the next, to conclude that the only fix was to manufacture it themselves.

The laboratory was built around the release decision rather than the sales sheet. Synthesis, purification, freeze-drying and filling sit under one quality system, and a lot is released when its purity and pH are on the certificate, not before.

Lyotek manufactures seventeen compounds today, in fifteen single vials and three blends, with two sets, and supplies all of it through authorised distributors so the laboratory can stay a laboratory.

Analytical bench with a balance under its draught shield and a pH meter with the probe in its holder.
Control A / 05 sits on this bench. Both displays are blank, because a reading belongs on a certificate and not on a website.

Manufacturing process

Five controlled steps between a sequence and a sealed vial. Each has its in-process control and its record.

Five steps, one buildingOne building, four bays

How the laboratory is organised

  1. Synthesis

    Sequence assembly, coupling controls and crude purification.

  2. Analytical

    HPLC methods, pH, release testing and the certificate of analysis.

  3. Fill and finish

    Lyophilisation, filling by mass, crimp sealing and labelling.

  4. Quality

    Procedures, batch records, deviations and the release decision.

Principles

Every lot is tested. No lot is released on the strength of the one before it.
Claims stop at the certificate. We state what was measured: purity and pH, per lot. Nothing that was not.
One accent colour, one meaning. Copper is the only accent on our labels and on this site, and a copper tick beside a value means that value was checked. Nothing else is marked as verified.
Distributors sell. Lyotek publishes no prices and takes no orders. Orders are placed with an authorised distributor.

Questions

Where can I buy Lyotek products?

Not on this site. Lyotek supplies authorised distributors, which handle availability, pricing and delivery. The laboratory publishes no prices and takes no orders.

What is in the vial?

A lyophilised cake of the named compound at the net quantity printed on the label, in a 2R tubular glass vial sealed with an aluminium crimp cap.

What documentation comes with each lot?

Every lot ships with its certificate of analysis, stating HPLC purity and pH. Further lot documentation is available to distributors and research organisations on request.

How are the products tested?

Each lot is tested for purity by HPLC and for pH before release, in house and by an independent third-party laboratory. Both results are on the certificate of analysis.

How should the vials be stored?

Lyophilised vials at 2 to 8 °C, protected from light. Bacteriostatic water at 20 to 25 °C. Storage conditions are printed on every label.

Who are the products intended for?

Research organisations, laboratories and qualified professional buyers, through authorised distributors. Products are supplied for research use only and are not for human consumption.

Provisional statements

The statements below are provisional, and the identifiers they stand for are not yet confirmed. Each is settled with the laboratory before the domain goes live. Nothing on this site is invented silently.

  1. 01The five process steps, as worded on the process page.
  2. 02The five in-process control lines, as worded on the process page.
  3. 03The class of the filling environment. The slot on the process page is left empty on purpose, and no class number appears anywhere on this site.
  4. 04The equipment list read as a list of what the laboratory owns, and the retention rack with any retained-sample policy.
  5. 05The certificate of analysis field list on the quality page.
  6. 06The lot lookup resolution path and its pending state on the certificate page.
  7. 07The packing description and the tray count on the distribution page.
  8. 08The scope line under each standard on the quality page.
  9. 09Certificate numbers and auditor names. Neither is shown. There is no cGMP certificate by definition, and the three ISO certificate numbers are not yet supplied, so the slots are drawn as ruled blanks. A fictitious serial is the one thing this site will not print.
  10. 10How authorised distribution works: territories, written terms and the enquiry route.
  11. 11The contact address, until the domain mailbox exists, and any response-time commitment.
  12. 12The year the laboratory began operating. It is held in the register and printed nowhere on this site, because a date that cannot be checked is worth less than the silence it replaces.

Enquiries

Documentation and distribution enquiries reach the laboratory directly. This site publishes no prices and takes no orders.

Email the laboratory