RESIDUAL SOLVENTS IMPURITIES. ICH Q3C

Introduction Solvents used in pharmaceutical industry are generally volatile organic compounds that are involved in many processes of both synthesis and purification of APIs, excipients and medicines. Their use is essential given that, in many cases, they allow to improve yields and selectivities of the processes, facilitate purification stages and even they lead to some…

Extractable and Leachable Impurities

What is an extractable impurity? Depending on their chemical nature and migratory properties from the container to the medium, these types of organic or inorganic impurities originating from the packaging materials may be classified as extractables or leachables. Therefore, extractables impurities can be defined as compounds released by the material in extreme temperature conditions, exposure…

How to Identify extractables and leachables Impurities

The packaging materials for pharmaceutical products are designed to protect them from environmental contamination. However, the presence of extractables and leachables originating from these packing materials in the pharmaceutical product can lead to a change in its composition that can in turn modify its therapeutic action, its organoleptic properties or its stability. Furthermore, the extractables…

Identification and quantification of impurities: a crucial aspect in pharmaceutical development

Introduction Any component present in an active ingredient or in a finished product which is neither the active ingredient nor an excipient is considered an impurity. The presence of impurities, even in small amounts, may influence the efficacy and / or safety of the drug, hence the importance of their toxicological assessment and control. Impurities…

Mutagenic impurities assessment following ICH M7 guideline

Mutagenic impurities assessment following ICH M7 guideline comprises impurities identification and classification, followed by a control strategy when DNA reactivity is confirmed for the impurity. According to this guideline, the first step in impurities assessment consist on the identification of both actual and potential impurities which could arise in the drug substance or product synthesis…