Why We Start with 100g of KSM in Process Development

In pharmaceutical Research and Development (R&D), synthesizing a new drug molecule is a multi-step journey, starting from Stage-1 to the final API.

The Challenge: Yield Loss and Impurity Formation: As we move from one stage to the next, two major challenges occur:

1. Cumulative Yield Drop: Isolation and handling losses add up at every single stage, so starting with a very small quantity leaves us with almost nothing by the final stage.
2. Impurity Formation: During the reaction process, impurities and unwanted by-products are naturally formed alongside our desired product. If we don’t control them early, they carry forward to the final stage, affecting the purity of the drug.

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Our Solution: Starting with 100g of KSM: To overcome these challenges, we intentionally start our lab-scale process with a robust 100-gram quantity of the KSM (Key Starting Material).

• Precise Calculations: We carefully calculate the reagent mole equivalents so that the reaction proceeds cleanly without leaving excess unreacted materials that form impurities.
• Optimization & Profiling: By running a 100g batch, we get enough material to study impurity profiling, monitor reaction temperatures, and optimize the yield at each individual step.

Starting with a 100-gram batch of KSM gives us a safe cushion against yield losses and provides enough sample to detect and control impurities. This practical step-by-step optimization ensures a pure, high-yielding, and successful scale-up from the lab to the industrial plant.