Toxicity, also known as biological harmfulness, generally refers to the relative ability of exogenous chemicals to cause direct or indirect damage when they contact or enter the living organism. Toxicity is closely related to the physical and chemical properties of the substance itself, as well as the dose, the way of contact and the time of contact. When assessing the risk of specific compounds in microspectrum medicine, the toxicity data of target compounds, such as NOEL, LOEL, LD50, etc., are determined by searching Toxline of the National Library of Medicine of the United States or SIDS of OECD of the European Union. For compounds without toxicity data, appropriate toxicity tests can be selected, NOEL and PDE can be calculated according to toxicity test results, and the limit can be calculated according to the maximum daily dosage of corresponding preparations. In summary, we combine the requirements of ICH, 1) to predict genotoxicity by software that conforms to the guidelines of ICHM7; 2) to retrieve existing databases of genotoxicity impurities; 3) to set reasonable limits based on relevant data.

Impurity profile analysis refers to the types and contents of impurities in medicines. According to the physiological activity of each impurity in medicines, it is the key to ensure the safety of medicines and the core issue of drug impurity profile control. The basic strategy of implementing impurity profile control proposed in 2010 summarizes the key technical issues related to impurity profile control are  three aspects as follows: sample classification of complex systems separation analysis, structural analysis of trace components and toxicity evaluation of trace components. WEIPU YIYAO has rich experience in synthesis and analysis. Impurity control strategies are formulated based on impurity mass spectrometry research and process routes. Impurities that may exist in practice are studied by various analytical means, and impurities that may exist are scientifically inferred from synthetic process routes.

The study of impurities is a very important part in the study of drug quality. When studying the structure of unknown organic impurities, it is often necessary to gather and analyze the impurities by HPLC.
WEIPU YIYAO experienced lots of impurity research, professional separation and purification personnel and project leaders, strong project management team, to ensure that we provide professional service for customers.

The synthesis and characterization of impurity structures are very important steps in the research of impurities. WEIPU YIYAO can provide a series of services, such as separation and purification, impurity analysis, impurity synthesis, confirmation of impurity structures and standardization of impurities.

ICH has reached a consensus on the validation of analytical methods, which are used to determine whether a particular analytical method can meet the needs of detection purposes. The evaluation of the analysis ability of the method can provide a basis for the application of the new method. According to the requirements of ICHQ2, WEIPU YIYAO systematically developed and analysis methods through the concept of QbD. This is a team with rich experience in the development, validation and testing of genotoxic impurities, elemental impurities, general impurities and residual solvents in raw materials and preparations, providing customers with a variety of services.

According to the requirements of ICH regulation, analytical method after verification can be used for release test. According to the purpose of detection, pharmaceutical analysis methods can be divided into three categories: identification, impurity analysis and content determination. In pharmaceutical analysis, the drug molecule is proved to be contained in the sample by the inherent properties of the drug through direct comparison between the sample and the standard substance. There are a laboratories which is GMP-like in WEIPU YIYAO. Once the method has been verified or confirmed in the microspectral laboratory, it can be used for release test.