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Certificate of Analysis (CoA)

A Certificate of Analysis is the batch-specific record that shows how a produced lot actually tested against its agreed specification. It is the single document a quality team relies on to release, or reject, an incoming shipment, and the reason "trust us" is never enough on its own.

What a Certificate of Analysis contains

  • The product name and the batch or lot number it applies to

  • Manufacturing date and, where relevant, an expiry or retest date

  • Each specification parameter, its acceptance limit and the actual measured result

  • The test method used for each result

  • Release status and the authorised signatory

What a batch is typically tested for

Identity

Confirmation that the material is what it claims to be, by the appropriate identification method.

Assay / content

The measured level of the declared active(s), usually by HPLC or an equivalent validated method.

Physical attributes

Appearance, plus format-specific checks such as weight, disintegration or fill.

Heavy metals

Lead, arsenic, cadmium and mercury against defined limits, typically by ICP-MS.

Microbiology

Total counts plus specified organisms (for example E. coli, Salmonella) within microbial limits.

Moisture / loss on drying

Where moisture is relevant to the specification or to stability.

When you get it

A Certificate of Analysis is issued for every batch we release and travels with the shipment, so each lot can be checked, line by line, against the specification your team agreed.

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