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Certificates and documentation: what to request and when

A Certificate of Analysis is the starting point, not the whole file. This note sets out the documents worth requesting and the point at which to request them.

Section 01

What a Certificate of Analysis should contain

At minimum: product name, catalogue reference, lot or batch number, appearance description, identity result with method, purity result with method, specification limits, release date and the name of the releasing analyst. If any of these fields is missing, the certificate cannot support a goods-in release on its own.

  • Product name and catalogue reference — ties the document to the order line
  • Lot or batch number — ties the document to the physical unit received
  • Identity result and method — usually mass spectrometry, observed against theoretical
  • Purity result and method — usually reverse-phase HPLC, reported as area percentage
  • Specification limits — the value the batch was released against
  • Release date and releasing analyst — establishes accountability and timing
Section 02

Records worth requesting alongside the certificate

The certificate states results; the underlying records show how those results were produced. Buyers assessing a new supplier usually want both.

  • HPLC chromatogram with column, gradient, flow rate and detector wavelength
  • Mass spectrum with ionisation mode and observed versus theoretical molecular weight
  • Batch traceability record covering synthesis, purification and filling dates
  • Retained sample confirmation, where long-term comparability matters
  • Method reference number, if the supplier operates a documented method library
Section 03

When to request each document

Requesting documents at the right stage avoids the common situation where a delivery arrives with a certificate that does not match the internal review template.

Section 04

Specifying a document format

Institutional buyers frequently require a particular certificate layout or a minimum field list. Providing the template or field list at quotation stage allows the documentation to be prepared to match, rather than being reformatted after delivery.

Format adaptation is normally free of charge when agreed before order confirmation, and can be impractical afterwards if the lot has already been documented and released.
This page provides general information for laboratory and procurement professionals. It is not medical, clinical or regulatory advice, and it describes no procedure for administration to a human or animal.
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Other working notes

Request a specification and quotation

Send the catalogue reference or target sequence, required purity, quantity and destination. The procurement desk returns a formal quotation with the documentation package and lead time.

Request quote Procurement guides