Balbir Singh Negi
GM Regulatory Affairs
SHAH TC Overseas Private Limited, Delhi, INDIA
22 years of industrial Exp,
M.Sc, MBA, Doctor of Science.
The usage of solvents in active pharmaceutical ingredients (API) and coating plants are very common in pharmaceutical industry. The organic solvents are mostly used in washing of product, cleaning of equipments and the reaction media for separation and purification. The cost reduction of the API products can be reduced by the distillation of mother liquor after establishing of yield in R &D, pilot plant and then in the commercial plant, the next process step is validation, done with fresh solvent of three consecutive batches and then done with three consecutive batches of recovered solvents from mother liquor. The product cost is mainly reduced by the distillation of product mother liquor or to do more research to reduce the quantity of solvent or manufacturing process without solvent.