Quality and analytical control

What is analyzed

Every batch undergoes a fixed panel before release. The panel does not change by compound: the acceptance criterion changes when the nature of the material requires it. The following methods describe the panel, not a result: the numerical result exists only in the batch certificate.

• Purity by reverse-phase high-performance liquid chromatography (HPLC).
• Identity by electrospray ionization mass spectrometry (ESI-MS), compared with the theoretical mass.
• Residual moisture by Karl Fischer titration.
• Bacterial endotoxins by the Limulus amebocyte lysate (LAL) assay.
• Appearance by visual inspection of the lyophilized material and vial.

Batch traceability

Each vial has its batch identifier printed on it. The batch links to a document page showing which independent laboratory issued the certificate and on which dates. The document's determinations and signed report are accessed with the order number of the customer who purchased that batch.

Who issues the certificate

Each batch certificate is issued by an independent laboratory, not Pureza. We have requested its accrediting body, accreditation number and scope; when available, all three details will be published here. Until then, we do not claim an accreditation we cannot cite.

Laboratory supplies

Catalog consumables (bacteriostatic water, syringes and swabs) are not chemical entities under study and are not subjected to purity or identity testing. Their specification is the one declared by the manufacturer on the packaging, and this site attributes no other specification to them.

What we do not claim

A certificate describes the composition of the material, not its biological behavior. No statement on this site about mechanisms or pathways is presented without identifying the experimental model in which it was studied, and none describes use in organisms.

Handling and storage

Materials are stored at a controlled temperature and dispatched with thermal protection when the compound requires it. Warehouse temperature records are kept in the internal log and can be requested in writing at contacto@pureza.mx.