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.
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
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.
