ISO/IEC 17025:2017 accredited labUSFDA-registered facility40+ years in analytical testing

Custom Synthesis

Custom Synthesis Services for Impurities, NDSRIs & Natural Products

Auriga Research designs and synthesises pharmaceutical impurities, nitrosamine drug substance-related impurities (NDSRIs), metabolites and natural products to order. Each compound is characterised in our own ISO/IEC 17025:2017 accredited lab and shipped with a CoA, and we can then develop and validate the analytical method and run your routine testing.

We are the only Indian reference-standard supplier that is also your testing lab. For nitrosamines that means one team from risk assessment to the NDSRI standard, the LC-MS/MS method and routine testing of your batches.

Discuss your molecule WhatsApp +91-7428116100

What we synthesise

Custom synthesis is for the compounds you cannot buy: a degradant seen only in your stability samples, the nitrosated form of your API, or a natural product compound you need as a reference. We design the route, synthesise the compound and characterise it.

  • Nitrosamine and NDSRI synthesis Nitrosated analogues of your API, synthesised to order when no catalogue standard exists.
  • Impurity synthesis Process impurities and degradants synthesised by a designed route, then characterised.
  • Impurity isolation and purification Isolating an unknown peak from your batch or a stressed sample.
  • Structure elucidation Identifying an unknown impurity from spectroscopic data.
  • Natural products Natural product compounds and their related impurities, synthesised to order.
  • Characterisation and CoA The data package that comes with every compound we synthesise.

How a project runs

  1. Enquiry and NDA

    Send the structure or name and your requirements. We sign a confidentiality agreement before you share anything sensitive.

  2. Feasibility and route review

    Our scientists review the literature and propose a route, flagging risks such as unstable intermediates.

  3. Quote with timeline

    You get the scope, price and expected timeline in writing before work starts.

  4. Synthesis with progress updates

    We synthesise the compound and update you at agreed points along the way.

  5. Purification and full characterisation

    The compound is purified to the agreed target and characterised in our analytical lab.

  6. Delivery with CoA and data package

    You receive the compound with its CoA and the supporting spectra and chromatograms.

Optional add-on

Method development, validation and routine testing

Our lab can use the same compound to develop and validate your analytical method, then test your batches.

Why Auriga: synthesis and testing under one roof

The only Indian reference-standard supplier that is also your testing lab. That changes what a synthesis project can deliver:

  • Synthesis and testing together The compound we synthesise can go straight to our analysts for method work and routine testing.
  • Nitrosamines end to end Risk assessment, NDSRI standard, LC-MS/MS method and routine testing from one supplier.
  • Confidential by default A confidentiality agreement before you share structures, and project details kept to the team working on them.
  • One technical contact One scientist follows your project from enquiry to delivery, so you never have to repeat yourself.
  • Regulatory-ready data Characterisation data organised so it can go into your regulatory submissions.

For nitrosamines the chain looks like this:

  1. Risk assessment

    Find where a nitrosamine could form in your API, excipients or process.

    Nitrosamine testing

  2. NDSRI standard

    We supply the nitrosamine standard or synthesise it to order, with a CoA.

    Catalogue standards

  3. LC-MS/MS method

    Our analytical team develops and validates a method using that standard.

    Method validation

  4. Routine testing

    Your batches are tested against the validated method in the same lab.

    Nitrosamine testing
  • Capabilities and facility Our synthesis and analytical set-up in one place.

What to send us for a fast quote

The more of this you include in your first message, the fewer questions we need to ask before quoting.

  • Compound name, or the structure as a drawing or SMILES
  • CAS number, if there is one
  • Parent API
  • Quantity and unit (mg, g or kg)
  • Purity you need
  • Intended use, for example method validation or toxicology studies
  • Your deadline

Send what you have. If something is missing, we will ask.

Frequently asked questions

Is my project confidential, and who owns the compound and the route?
We sign a confidentiality agreement before you share structures or project details, and your project is not disclosed to anyone else. Ownership of the compound, the route and the data is agreed in the quote and contract, so raise any IP requirements when you first contact us.
What happens if the synthesis does not work?
Some routes fail or give a lower yield than planned. We review feasibility before quoting so the main risks are known at the start, and we tell you as soon as a route runs into trouble. How the cost of an unsuccessful attempt is handled is set out in your quote before work starts.
How long does a custom synthesis project take?
It depends on the molecule. A known impurity with a published route is usually quicker than a new NDSRI or a complex natural product. You get an expected timeline with the quote, and progress updates while the synthesis runs.
What characterisation is included?
Every compound is characterised in our own lab and supplied with a CoA and a data package that covers identity, purity and content. The techniques used depend on the compound and are agreed in the quote.
What are the minimum and maximum quantities?
Quantities depend on the compound and the route. Tell us the amount and unit (mg, g or kg) you need, and the quote will confirm what we can supply.
Can you also validate the method and test our samples?
Yes. Synthesis and testing sit in the same organisation, so the compound we synthesise can go straight to our analytical lab, which can develop and validate the method and then run your routine batch testing. See method development and validation.

Discuss your molecule

Send the structure or name, the quantity and your deadline. Everything you share is treated as confidential.

Chat on WhatsApp +91-7428116100 Or call +91-7428116100
Call Now Get a Quote

Type to search services, tests, and locations…