甲磺酸艾氟替尼的晶型、粒度分布在原料药的质量标准中进行控制，晶型在制剂

The crystal form and particle size distribution of efitinib mesylate are controlled in the quality standards of the drug substance, and the crystal form remains stable during formulation production and stability studies. <br>A free base by impurities not more than 0.25% of the labeled amount of <br>other individual impurity peak area peak area of control solution not greater than 0.2 times (0.2%) <br>meet the requirements of the 0941 General Pharmacopoeia 2015 Edition, uniformity of content <br>containing methanesulfonic acid Ai Flutinib is calculated according to afatinib (C28H31F3N8O2) and should be 90.0% to 110.0% of the labeled amount. <br>This research content is a summary of the development process of the production process of afatinib mesylate tablets, and the quality comes from design QbD) method shows the production process development process and the acquired product knowledge and understanding. <br>The focus of production process development is on high-risk unit operations, based on experience, models, development and risk assessment processes to determine the material properties and process parameters that affect the quality of the final product. <br>For each unit operation, multivariate DOE is used to confirm the relationship between input variables, process parameters, output product attributes and final product quality. <br>Formulate key quality attributes, production environment and control strategy of intermediate products, and convert risks to ensure the quality of final products. <br>Based on the in-depth understanding of products and production processes, determine the design space and risk assessment methods, enlarge the rules, technology transfer and real-time release methods. <br>Based on the target product profile (TPP), a target product quality profile (QTPP, as shown in Table 3.2.P.2.3-2) was developed, describing the product's dosage form and product attributes, and on this basis, further obtaining key product quality parameters. <br>Use risk assessment to identify which variables and unit operations are most likely to affect the product's key quality parameters, and pay attention to these variables and unit operations as high-risk factors in the product development process. <br>Convenience of dose adjustment in clinical research, <br>pre-clinical and clinical pharmacy, pharmacodynamics, pharmacokinetics and safety evaluation of registered application forms, and registered application forms.

The crystal level and particle size of methamphetamine efluofinib are controlled in the quality standards of api, and the crystal type remains stable in the study of preparation production and stability.<br>Impurity A must not exceed 0.25% of the marked amount by free alkali<br>Other individual impurity peak area must not be greater than 0.2 times (0.2%) of the main peak area of the control solution<br>Meet the requirements of content uniformity under the General Principles 0941 of the Pharmacopoeia 2015<br>Eflutinib with methsuldonic acid is calculated according to eflutinib (C28H31F3N8O2) and should be 90.0% to 110.0% of the marked amount<br>This study is a summary of the production process development process of the methafsultine eflutinib tablet, which shows the production process development process and the acquired knowledge and understanding of the product using the quality derivation from the design (QbD) method.<br>The focus of production process development is on high-risk unit operations, which determine the nature of materials and process parameters that affect the quality of the final product, based on experience, model, development and risk assessment processes.<br>For each unit operation, the correlation between input variables, process parameters, output product attributes and final product quality is confirmed with multiple DOEs.<br>Develop key quality attributes, production environment and control strategies for intermediates, and convert risks to ensure final product quality.<br>Based on an in-depth understanding of the product and the production process, determine the design space and risk assessment methods, zoom in on the rules, technology transfer and real-time release methods.<br>Based on the Target Product Profile (TPP), a target product quality profile (QTPP, as shown in Table 3.2.P.2.3-2) is developed, describing the dosage form and product attributes of the product, on which the key quality parameters of the product are further obtained.<br>Identify which variables and unit operations are most likely to affect the product's key quality parameters by using risk assessment methods, and pay attention to these variables and unit operations as high risk factors during the product development process.<br>The convenience of dose adjustment in clinical studies, registered application stos<br>Preclinical and clinical pharmacology, pharmacodynamics, pharmacodynamics and safety evaluation, has been registered to declare the dosage form.

The crystal form and particle size distribution of efetinib mesylate are controlled in the quality standard of API, and the crystal form is stable in the preparation production and stability research.<br>Impurity A shall not exceed 0.25% of the marked amount according to free alkali<br>The peak area of other single impurity shall not be greater than 0.2 times (0.2%) of the main peak area of the control solution<br>Meet the requirements of content uniformity under general rule 0941 of Pharmacopoeia 2015<br>The content of efetinib should be 90.0% ~ 110.0% of the labeled amount according to the calculation of efetinib (c28h31f3n8o2)<br>The content of this study is a summary of the development process of the production process of efetinib mesylate tablets. The development process of the production process and the acquired knowledge and understanding of the product are demonstrated by the method of quality from design (QBD).<br>The focus of production process development is on high-risk unit operation. Based on experience, model, development and risk assessment process, the material properties and process parameters affecting the quality of final products are determined.<br>For each unit of operation, multiple DOE is used to confirm the relationship among input variables, process parameters, output product attributes and final product quality.<br>Formulate the key quality attributes, production environment and control strategy of intermediate products, and convert the risks to ensure the quality of final products.<br>Based on the in-depth understanding of products and production processes, the methods of design space and risk assessment, amplification rules, technology transfer and real-time release are determined.<br>Based on the target product profile (TPP), the target product quality profile (qtpp, as shown in table 3.2. P.2.3-2) is developed, and the dosage form and product attributes of the product are described. On this basis, the key quality parameters of the product are further obtained.<br>The risk assessment method is used to identify which variables and unit operations are most likely to affect the key quality parameters of products, and pay attention to these variables and unit operations as high-risk factors in the process of product development.<br>Convenience of dose adjustment in clinical research, registered dosage forms<br>Pre clinical and clinical pharmacy, pharmacodynamics, pharmacokinetics and safety evaluation, registered and applied dosage forms.