1 2 ethanediol diacetate

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Stability Testing of Active Pharmaceutical Ingredients


Challenges Faced by Buyers


 

An API is any substance or combination of substances used in a finished pharmaceutical product that is intended to provide pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease. APIs can be derived from natural sources or synthesized through chemical processes. The complexity of their structure can vary greatly, from simple molecules to large biological molecules such as proteins and peptides.


In the ever-evolving landscape of pharmaceuticals, the term bulk drug intermediates has gained significant prominence. These intermediates play a crucial role in the production of active pharmaceutical ingredients (APIs), which are the primary components in drug formulations. Understanding the significance, types, and production processes of bulk drug intermediates can provide valuable insights into the pharmaceutical industry’s operations.


Pyrroloquinoline quinone (PQQ) is a naturally occurring compound that has garnered attention in the fields of nutrition and health science for its potential health benefits and protective effects on cellular function. This small quinone molecule, found in various foods like fermented soybeans, green peppers, and kiwi, plays a pivotal role in cellular bioenergetics and antioxidant activity. With ongoing research revealing its multitude of properties, PQQ is being celebrated as a key player in promoting human health and cognitive function.


2. Process Development


In 2020, the growth of China’s API export was stimulated by the epidemic, which boosted the global demand for ANTI-epidemic APIS, and also affected the production of other major API producers such as India and the European Union. As a result, the transfer orders of China’s API from the international market increased.  Specifically, the export quantity of China’s API increased by 7.5% year on year, reaching 10.88 million tons.  From specific export category, anti-infection, vitamins, hormones, antipyretic analgesic, part of antibiotic resistance to disease related API category of export amount is mostly realized the different levels of growth, some specific varieties is growing rapidly, such as dexamethasone exports rose 55% year-on-year, lamivudine, vitamin C, vitamin E and other exports more than 30% year-on-year growth,  Paracetamol, annannin and other exports year-on-year growth of more than 20%.

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