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After synthesis, the crude API needs to be purified to eliminate impurities and obtain the desired purity level, often 98% or higher. Common purification techniques include recrystallization, distillation, chromatography, and membrane filtration. Each technique has its advantages and is selected based on the specific characteristics of the API. The purification process is critical as impurities can significantly impact the safety and efficacy of the final pharmaceutical product.
pharma api production process

The synthesis of ethylene diformate can be performed through several methods, with the most common being the direct esterification of ethylene glycol with formic acid. In this process, the reactants are typically heated in the presence of a catalyst to promote the formation of the ester bond while releasing water as a byproduct. Alternatively, transesterification reactions involving other esters and ethylene glycol can also yield ethylene diformate. These approaches can be optimized by controlling temperature, pressure, and reaction time to improve yield and purity.