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Documentation

Specification / technical data sheet

The specification is the agreed definition of the product, the target values and acceptance limits that every Certificate of Analysis is then measured against. Agreeing it up front is what makes "in spec" mean the same thing to both sides.

What a specification sheet contains

  • Product description and intended dosage form

  • Declared actives and their target amounts

  • Physical properties and appearance

  • Purity and contaminant limits, including heavy metals and residues

  • Microbiological limits

  • Packaging, storage conditions and shelf life

When you get it

We prepare and share the specification at project setup and on request, so your regulatory and procurement teams can review exactly what will be produced before a single batch runs.

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