Know the Significance of Impurity Characterization in the Bulk Drugs

Today, there are several global sourcing companies which focus upon purity needs and identification of impurities in Active Pharmaceutical Ingredients (APIs). In order to ensure good quality of drugs, impurity level must be examined carefully. The different kinds of impurities in pharmaceutical products include heavy metals, ligands, reagents, catalysts, etc. Apart from these, you can also obtain degraded end products after manufacturing bulk drugs from hydrolysis, decarboxylation, oxidative degradation and others. Various methods like gas-liquid chromatography, electrophoresis and extraction methods are used to remove impurities from pharmaceuticals.

It is really important to understand what constitutes an impurity in bulk drugs and determine their potential source. Impurities in pharmaceuticals indicate the presence of unwanted substances that develop during the formulation of APIs. Their presence, even in small amounts, degrades the quality and efficacy of the pharmaceutical products.

Selective analytical methods are used by the organizations which serve pharmaceutical, medical devices and biotech companies with APIs, chemicals and intermediates. These methods used to estimate the impurity level do not come to an end on completion of R&D phase of any new drug. Some new impurities may also be traced when changes are made in the synthesis, formulation or manufacturing processes. So, it is necessary to ensure that no new impurities are present in bulk drugs in the course of scaling up process. Therefore, every analytical step involved during the scaling up process holds an utmost importance.

No doubt, the bulk drug industry forms a base of all types of pharmaceutical industries. Over the past few years, a lot of attention has been paid towards the quality of APIs that arrive in the market. The major challenge for bulk drug and pharmaceutical industries is to manufacture and supply the highest quality products in multiple sectors. So, it becomes necessary to conduct regular quality control checks for maintaining a certain standard of quality and purity of the drug.

Purity of active pharmaceutical ingredient depends on ample factors such as raw materials, their manufacturing methods, type of crystallization and purification processes. Therefore, pharmaceutical industries should set limits for allowable impurities in bulk drugs on the basis of factors like daily dose, target population, etc. The highly advanced separation methods play a major role in scientific research. With the help of these methods, companies can separate and quantify every component, thus making the process of separation and characterization quite simpler.

Isolation of impurities is quite crucial during the synthesis of drugs as it helps in improving the efficacy, safety and quality of bulk drugs and finished products.

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