Route Selection

Generally, an API involves multiple process routes. The selection of routes will affect not only the possibility of industrial manufacturing, but also the material cost, product quality, and even the environment. We provide services that include the customization of initial API, as well as the design and determination of synthetic routes. With our research into products to be developed and information checked, we will analyze the feasibility of such routes, and the source of synthetic materials, to check if such routes are involved in intellectual property issues, if the cost is acceptable, and if such routes are in compliance with green chemistry principles. After that, we will conduct route selection, process optimization, quality research, and process verification to ensure project quality.

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Service we provide

Medicilon’s API process route selection and optimization services include:
Route design and selectionSalt form selection, research, and process development of crystal formSalt base selectionCrystal form selectionCrystal form research (lab-scale testing and kilogram-level )Parameter optimization for determined routeStatistical and experimental design, based on quality by design (QbD) principles and multivariate data analysisQuality research on API and intermediatesDevelopment and verification of analytical methodsTechnology transfer and process verification
With our evaluation of the selected route’s technological feasibility, usability of equipment, availability of raw materials and reagents, steps of reaction, patent protection, and environmental impact, we help our clients select and develop reliable, low-cost, safe, and environment-friendly mass-production API process routes for the selection of both emergency routes in the early stages of drug development and the economic routes for formal drug development.

Service Cases

Medicilon assists Palaatu to obtain clinical approval for Class 1 new drug PA9159 for rhinitis.webp