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Dr Sahu’s Laboratories

Custom Synthesis

From idea to pilot scale — we design, synthesize, and characterize APIs, intermediates, and impurities with regulatory-ready documentation.

Tailored Chemistry, Scalable Outcomes

We collaborate with discovery, process, and QA/RA teams to deliver synthesis, isolation, and characterization — with tech transfer and batch support.

Speed with science: Route scouting, DoE optimization, and impurity pathways mapped early to de-risk scale-up.
Fit for filings: Data packages aligned to CTD expectations; traceable raw data and version-controlled reports.

What We Offer

APIs & Intermediates

Development of APIs and intermediates on request, including route scouting and process optimization.

Impurity Synthesis & Elucidation

Targeted impurity synthesis with structural elucidation (NMR, MS, IR) and reference standard delivery.

Pilot-Scale & Regulatory Batches

Pilot-scale support for R&D and regulatory batches with tech transfer and documentation.

Why Choose Dr Sahu’s for Custom Synthesis

  • Experienced process chemists with strong impurity pathway understanding.
  • Stage-appropriate controls from discovery to pilot scale.
  • Analytical integration (HPLC/GC/LC-MS/MS, NMR via partners) for faster decisions.
  • Documentation aligned to CTD with clear traceability and CoAs.
  • Transparent communication, weekly updates, and IP-respecting workflows.

How It Works

Briefing — Target profile, specs, timelines, and IP/NDA setup.
Route & Risk — Route scouting, safety review, and DoE for key steps.
Make & Measure — Lab synthesis, in-process analytics, and impurity mapping.
Scale & Transfer — Pilot runs, documentation, and tech transfer support.
Deliver — Material, CoA, spectra package, and final report.

FAQs

What analytical package do you provide with impurities?

NMR (1H/13C), mass spectrum, IR, chromatographic purity, and CoA; additional tests on request.

Can you support tech transfer to our plant or CMO?

Yes, we provide batch records, critical parameters, and on-site/remote support for smooth transfer.

Do you work under NDA and respect IP?

Absolutely. We execute NDAs, use controlled access, and share only need-to-know information.

Start Your Custom Synthesis

Share your target, quantity, and timeline — we’ll respond with a route concept and estimated plan.