Case Study
Process Development of RSM of a Ph2 API
- Scope:
Process Development of RSM followed by 300 gm for Initial shipment.
- Complexity:
RSM of a Phase-2 API, chiral chemistry and discrepancy in Purities between the batches. The current source was not helping to solve the problem.
- Quality & Yield:
Purity inconsistency as the Sample must be stored under -200C
- Accomplishment:
It was identified that the purity was affected by process carryovers from the Chiral RSM. Our scientists quickly sourced a local vendor and conducted a few trial batches. A rapid stability test confirmed that the RSM could be stored at 2°-8° C.
Shilpa delivered 300 gm ahead of timelines and become a continuous supplier for subsequent requirements.
