Impurities & Reference Standards

Synthesis and characterisation of API impurities, metabolites and reference compounds.

Regulatory filings need well-characterised impurities. We synthesise the structures you specify — or the ones your analysis has found — and deliver them with structure confirmation data.

Scope

  • Process and degradation impurities
  • Isolation, synthesis and structure confirmation
  • Small packs for analytical use

Deliverables

  • Reference material with characterisation data
  • Purity assignment

How a project runs

  1. 01
    Inquiry & CDA

    Share the target and requirements under a confidentiality agreement.

  2. 02
    Route Design

    Feasibility, route options, timeline and quotation.

  3. 03
    Lab Synthesis

    Synthesis with in-process analytics and progress reports.

  4. 04
    Pilot & Scale-up

    Process optimisation, safety review and pilot batches.

  5. 05
    Delivery & Supply

    Product, COA and documents; ongoing commercial supply.

Have a molecule in mind?

Send us the structure or CAS number, the scale and the timeline. We reply within one working day, and can sign a CDA first.

Start a Project