— Solution · Small molecule →
Small molecule
Research to release for small-molecule medicine — one record from the first discovery experiment to the QC batch record and Certificate of Analysis.
- 01Discovery
- 02Process development
- 03Analytical development
- 04Clinical manufacturing
- 05QC & release
From the first reaction to the Certificate of Analysis
A medicinal-chemistry idea starts as a freeform experiment: structures registered, stoichiometry calculated in the notebook, spectra and chromatograms attached to the exact sample they came from. The same procedure, written once, becomes the process-development method — no re-keying, no export.
That recipe becomes an electronic batch record for clinical manufacturing, executed step by step with the SOP alongside and specifications checked as values are entered. Analytical release testing runs against result schemas on the same samples; an out-of-spec result opens a quality event automatically and links back to the request that produced it.
What’s connected
- Registry — compounds, salts, batches and their genealogy
- Chemistry sections — reaction scheme, stoichiometry, yield, compound enumeration
- Analytical — chromatography, NMR and spectra parsed to one model and bound to samples
- Batch records — line clearance, material dispensing, charge and react, in-process controls, e-signature
- QC — test requests, result schemas, OOS handling, change control, Certificate of Analysis
See it on the platform: Research · Lab & QC · Manufacturing.
In the product
