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Certificates

Four standards, no certificate numbers

Quality system

Four standards govern how we manufacture, test and fill. Here is what each one covers and what we can send you.

Release testing

Release testing is not a sample of production. Every lot is tested for HPLC purity and pH before it is cleared for supply, and both results are recorded on its certificate of analysis.

Third-party testing

Alongside in-house release testing, an independent laboratory tests purity and pH. The certificate of analysis carries both results and names the laboratory; this site does not.

The part of a lot a buyer can check is paper.

01Certificate per lot

A lot is not released until it is tested

Release is a decision against a written specification, taken once per lot.

The lot is tested for purity by HPLC and for pH.
Results are compared against the specification, not against the previous lot.
A lot that does not meet the specification is not released.

The purity specification is 99% or greater. A specification is not a batch result.

Purity is confirmed by an independent third-party laboratory alongside our own release testing.

LotHPLC puritypHSpecificationReleasedHeldWith certificateNot suppliedLotHPLC puritypHSpecificationReleasedWith certificateHeldNot supplied

Both tests meet the specification. The lot is released with its certificate.

The held branch is drawn at the same weight as the released branch. A gate that only ever opens is decoration.

  • 02Release tests
  • 01Specification
  • 02Outcomes

A certificate of analysis with every lot

Every lot ships with its certificate. The fields listed here are the fields it carries.

Further lot documentation is available to distributors and research organisations on request.

Specimen. No lot values are shown, and no certificate number is claimed.

Provisional

The certificate field list, until the certificate template is confirmed

Certificate of analysis

Specimen, values not shown

Product
Lot number
Presentation
Net quantity
Appearance
HPLC purity
pH
Storage condition
Date of release
Retest date

No certificate number is shown, and none is claimed

What cGMP-aligned means here

Current Good Manufacturing Practice is a set of principles for controlling how a product is made: written procedures, trained operators, controlled environments, a record for every batch, and testing before release.

Lyotek manufactures to those principles. Procedures are documented, each lot carries a batch record, and nothing is released without testing. We describe this as cGMP-aligned rather than certified, because that is precisely what it is.

Four standards, described by what they cover

Each card names the standard and the scope it governs. The certificate slot is drawn and left blank.

  1. cGMP

    Good Manufacturing Practice

    Scope: synthesis, lyophilisation, filling and release. Manufacturing controls are based on the principles of current Good Manufacturing Practice.

    CertificateAligned practice, no certificate

  2. ISO 90012015

    Quality management system

    Scope: quality management of manufacturing and supply.

    Certificate

  3. ISO 170252017

    Laboratory competence

    Scope: purity, pH and release testing.

    Certificate

  4. ISO 14644-12015

    Cleanroom classification

    Scope: the controlled filling and sealing environment.

    Certificate

No certificate number is shown, and none is claimed. No certifying body and no auditor is named. Both sit in the register below, and neither is invented here.

Provisional

The scope line under each standard

  • 04Standards
  • 00Certificate numbers shown
  • 00Regulators named

Enquiries

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

Email the laboratory