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Synthesis Analytics
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Services

Chemistry, characterisation and the paperwork that makes it count.

Six services, one thread running through them: making sure the compound in the vial is genuinely the compound on the label, and that you can prove it.

Impurity Synthesis & Isolation Reference & Working Standards Custom Synthesis & CRAMS Analytical Method Development Regulatory & Documentation Support Knowledge & Training Programmes
01 / 06

Impurity Synthesis & Isolation

From a peak on your chromatogram to a characterised standard in hand.

We take unknown peaks from stability, stress and release testing, propose a structure, synthesise or isolate the compound, and deliver it with the full analytical package needed to justify it in a regulatory filing.

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What this includes

  • Unknown peak identification from your chromatographic data
  • Preparative HPLC isolation where synthesis is impractical
  • Structure elucidation by NMR, HRMS and IR
  • Genotoxic and nitrosamine impurity standards
02 / 06

Reference & Working Standards

Standards you can defend during an audit.

Every standard is released against a documented characterisation protocol with assigned potency by mass balance, so the value on the certificate is traceable to the raw data behind it.

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What this includes

  • Primary reference standards with full characterisation dossier
  • Working standards qualified against pharmacopoeial RS
  • Certificate of Analysis, MSDS and spectral data with every vial
  • Custom pack sizes from 10 mg upward
03 / 06

Custom Synthesis & CRAMS

Molecules that are not on anyone’s shelf.

Contract research and manufacturing from route selection through process optimisation, HAZOP review and technology transfer — scoped to your timeline and your regulatory pathway.

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What this includes

  • Route scouting and feasibility assessment
  • Process development, optimisation and scale-up
  • Stable isotope-labelled and deuterated analogues
  • Technology transfer packages for commercial manufacture
04 / 06

Analytical Method Development

Methods that survive validation.

Development and validation of stability-indicating methods, forced degradation studies and impurity profiling in line with ICH expectations.

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What this includes

  • Stability-indicating HPLC and UPLC methods
  • Forced degradation and photostability studies
  • ICH Q3A / Q3B impurity profiling
  • Method transfer and co-validation support
05 / 06

Regulatory & Documentation Support

The paperwork that makes the science count.

Dossier-ready documentation, impurity justification and query response support for filings across regulated and semi-regulated markets.

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What this includes

  • Impurity qualification and justification narratives
  • CMC section support and deficiency responses
  • Change control and comparability documentation
  • DMF and ANDA supporting data packages
06 / 06

Knowledge & Training Programmes

Capability, transferred.

Hands-on programmes for analytical and QC teams covering impurity profiling, method troubleshooting and pharmacopoeial interpretation.

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What this includes

  • Impurity profiling workshops
  • Chromatography troubleshooting clinics
  • Pharmacopoeial monograph interpretation
  • On-site or remote delivery

Engagement

How a project actually runs.

No black boxes. You see the route before we commit, and the data as it is generated.

  1. 01

    Enquiry & scoping

    Send the compound name, CAS number or the chromatogram you are trying to explain. We confirm availability, scale and lead time — usually within one working day.

  2. 02

    Route & feasibility

    For non-catalogue compounds our chemists propose a synthetic route, flag the risks and agree a milestone plan before work begins.

  3. 03

    Synthesis & purification

    Synthesis, work-up and purification to the agreed purity specification, with in-process checks at each stage.

  4. 04

    Characterisation

    Identity and purity established by NMR, mass spectrometry, chromatography and IR, and the analytical dossier compiled.

  5. 05

    Release & dispatch

    Batch released against the characterisation protocol, packed under inert conditions where required, and shipped with full documentation.

Start here

What we need from you.

The more of this you can send, the faster and more accurate our first answer will be — but a compound name on its own is a perfectly good place to start.

  • 1

    Structure or name

    A structure, a CAS number, a pharmacopoeial impurity designation — any one is enough to begin.

  • 2

    Analytical data

    Retention time, UV spectrum, mass and the method conditions, if you have an unknown peak.

  • 3

    Quantity and purity

    How much you need, and the purity your method requires.

  • 4

    Timeline

    When you need it in hand, and what it is blocking.

Brief our chemists

Describe the compound or the problem. We reply within one working day.

Your details are used only to answer this enquiry.

Rows of stoppered glass tubes under warm light

Next step

Can’t find the impurity you need?

Send us the compound name, the CAS number, or simply the chromatogram you are trying to explain. Our chemists will come back with availability, scale and a realistic timeline.

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