Polymeric materials in manufacturing processes: a new theat of extractable impurities

1. Introduction In the last few years, elastomer, thermoplastic or thermostable plastic polymeric materials have become established as basic components in many pharmaceutical and biotechnological manufacturing processes. The range of polymeric materials available in the industry is very broad and materials have been developed with very different structural properties depending on the desired application. Some…

Residual solvents impurities ICH Q3C

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…

Organic impurities

Organic impurities: ICH Q3A AND ICH Q3B

Introduction Identification and quantification of impurities in active ingredients and drugs products is a crucial aspect in pharmaceutical development to ensure the quality and safety of the product. 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…

Elemental Impurities ICH Q3D: Data and reality

The implementation of ICH Q3D has already become in a reality, and the requirements and implementation dates represent a challenge for the pharmaceutical industry. Based on the document ‘Implementation strategy of ICH Q3D guideline’ (EMA/CHMP/QWP/115498/2017 – Committee for Medicinal Products for Human use (CHMP), there are two different approaches to risk management of elemental 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…

Toxicological assesments using (quantitative) structure-activity relationships ((Q)SAR) methodologies

When assessing pharmacological and toxicological profile of chemical structures, several approaches are possible, including comprehensive scientific literature review, data migration from analogue compounds or through preclinical and clinical studies. Nevertheless, the need to generate data by means of other methods than animal tests is widely acknowledged and has led to an overall development of computational…