Impurities in API Risk Assessment

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Impurity risk assessment of Active Pharmaceutical Ingredients (APIs) is the process of determining the potential impact of impurities present in a drug on patient safety and is essential for ensuring drug safety and improving drug quality. Protheragen-ING combines knowledge and skills from various fields such as chemistry, toxicology, analytics, and regulatory affairs to provide specialized impurity risk assessment services to help detect and quantify the presence and level of impurities in APIs. We use appropriate analytical methods for impurity detection, which may include High-Performance Liquid Chromatography (HPLC), Gas Chromatography (GC), Mass Spectrometry (MS), and others.

Fig.1 Impurities in API Risk Assessment.

Diversified Classification of Impurities

According to its physical and chemical properties, generally divided into organic impurities, inorganic impurities, and residual solvents.
According to the source can be divided into process impurities, degradation impurities, and impurities mixed from the reactants and reagents.
According to toxicity can be divided into general impurities and toxic impurities.

API Impurity Risk Assessment Program

Items	Introduction	Services
Genotoxic Impurity Studies	Genotoxic impurities (GTI) are substances that can cause DNA mutations, chromosome breaks, or DNA recombination, can induce gene mutations lead to chromosome breaks and rearrangements at very low concentrations, and are potentially carcinogenic.	We can provide genotoxic impurity studies under various relevant regulatory requirements, focusing on providing a series of complete solutions including assessment reports, method development, validation, and sample testing for genotoxic impurities that may be generated in the production process of APIs.
Elemental Impurities Studies	Due to the influence of the regional environment (heavy metal pollution), there has always been a high level of concern for elemental impurities in drug declarations.	Comprehensive risk assessment of elemental impurities that may be introduced into a drug according to the application of ICH Q3D.
Related Substance Studies	APIs may also have other organic impurities during the manufacturing process, from sources such as starting materials, intermediates, by-products, and degradation products, due to their potential impact on the quality, safety, and efficacy of the drug product.	Combined with the characteristics of API and production process, we analyze the impurity profiles of API, intermediates, excipients, degradation products, and various related substances generated during the production process, and research and establish reliable detection methods with detection limit, specificity, quantification limit, linearity, etc. by the standard requirements and customer requirements.
Residual Solvent Studies	The API production process uses or generates some volatile organic compounds, which are toxic or harmful to the environment and are difficult to remove completely. In addition to this, the final purification of most pharmaceutical ingredients includes a crystallization process that retains small amounts of organic solvents that can become toxic impurities or cause drug degradation.	By ICH, USP, ChP, and other relevant regulations and in combination with the API and the characteristics of the production process, we develop and validate methods for residual solvent testing, provide data from the method development process, method validation programs, and reports, and cooperate with the customer in the transfer of the method.

Fig.2 API Impurity Risk Assessment Program.

Advantages of API Impurity Analysis Service

Determination of possible impurities: According to the chemical properties of the drug and the manufacturing process, determine the types of impurities that may be present, which may be organic compounds, inorganic salts, heavy metals, microorganisms, residual solvents, etc.
Impurity limit standards: Determine the limit standards for each impurity according to the requirements of relevant regulations and national pharmacopeias.
Toxicological assessment: Toxicological assessment of known impurities to understand the potential harm to the human body, including the assessment of its carcinogenicity, teratogenicity, mutagenicity, allergenicity, neurotoxicity, and so on.
Risk control measures: According to the results of the impurity risk assessment, take necessary measures to reduce the risk of impurities.

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