2022-01-04
What issues should be paid attention to in the research on the preparation process of APIs?
RENHE ENVIRONMENTAL
01
RENHE ENVIRONMENTAL
02
RENHE ENVIRONMENTAL
3
Company Profile
A high-tech enterprise focusing on R&D, production and sales of extractant series, pharmaceutical intermediates and fine chemical products
Yichun Shanggaoyuan Dali Chemical Co., Ltd.
Yichun Shanggaoyuan Dali Chemical Co., Ltd. (formerly Jiangxi Shanggao Yongsheng Chemical Co., Ltd.) was relocated and expanded. Now, the company is located in Jindui Industrial Park, Shanggao County, Jiangxi Province. It is an enterprise focusing on the research, development, production and sales of extractants, pharmaceutical intermediates and fine chemical products.
The company and its production base cover a total area of 24,000 square meters and a construction area of 8,000 square meters. The company's main products are: Diisooctyl phosphate (P-204), 2-thiophenecarboxaldehyde, 1-acyl-2-sulfosodium indium indoles.
Company Profile
Certification
Certificate
Culture
Why choose us
The company has complete safety, environmental protection, fire protection facilities and public works. It has facilities such as R&D room, analysis room, production workshop and warehouse
Technical strength
Professional equipment
and technical personnel
Product strength
Focus on the research and
development of extractant series,
R & D strength
It has facilities such as
R&D room, analysis room,
production workshop
Service Guarantee
Always regard quality as life
and reputation as the purpose
PRODUCTS
The company's main products are: diisooctyl phosphate (P-204), 2-thiophenecarboxaldehyde, 1-acyl-2-sulfosodium indole
NEWS
With professionalism and open cooperation, realize the integration and optimization of resources, and pursue win-win results with all walks of life
-
The preparation of APIs is the initial stage of drug research and development, and is the basis of drug research and development. It mainly provides detailed information for quality research, provides preparation processes in line with industrial production, and provides pharmacology and toxicology research, preparation research, and clinical research in the process of drug research and development. Provide qualified APIs. Next, let's take a look at what issues should be paid attention to in the research on the preparation process of raw materials? 1. The selection and design of the synthetic circuit must be based on. In the application registration materials, it is required to explain in detail the background of the research, the basis for the preparation process and route. In the case of a drug with a new chemical structure, the basis and principle of the creation should be explained. If it is a generic drug, several different literature routes should be provided for analysis and comparison, detailing the reasons for the route adopted, and explaining how it was improved. and basis for improvement. The evaluation of the synthesis route is aimed at ensuring stable product quality, with particular emphasis on the feasibility of the selection and design of the process route (for example, whether the raw materials are readily available, the length of the synthesis steps, the level of yield, and whether the reaction conditions can be industrialized), Controllability (whether the reaction conditions are mild and easy to control), stability (whether the quality of the intermediates is controllable, and whether the quality and yield of the final product are stable), advanced (advantage of the adopted route compared with the literature route), and rationality (Cost and price and toxicity of raw materials, reagents, solvents, etc.). 2. The starting materials, reagents and organic solvents should be standardized. In the newly issued "Technical Guidelines for Chemical Drug Research", it is also pointed out that raw materials include the starting materials, solvents, catalysts, etc. of the reaction. It also emphasized that the legal source certificate and related process routes and quality standards should be provided for special special intermediates, and the raw materials used in drug production should be purchased from units that meet the regulations. In the process of API preparation, the quality of starting materials, reagents and solvents is directly related to the quality of the final product and the stability of the process route. Different specifications of starting materials, reagents, and solvents will directly affect the process, and different quality of starting materials, reagents, and solvents will introduce different impurities. Therefore, the general principles for the selection of starting materials should be: (1) The quality is stable and controllable, and there should be sources, standards and inspection reports from suppliers. If necessary, internal control standards should be established according to the requirements of the synthesis process. (2) For special special intermediates, it is even more important to provide relevant process routes and internal control quality standards. (3) There should be a certain understanding of the impurities that may be introduced in the preparation process of the starting materials, especially the impurities and isomers introduced by the starting materials, relevant research should be carried out and quality control methods should be provided; For the central starting material, limits for enantiomers or diastereomers should be established as impurities. Selection of solvents and reagents: Generally speaking, reagents with lower toxicity should be selected; the selection of organic solvents should generally avoid the use of first-class solvents and control the use of second-class solvents. At the same time, the toxicity of the reagents and solvents used should be explained so as to be controlled in the production process. For the detailed requirements of organic solvent selection, please refer to the technical guidelines for the study of organic solvent residues in chemical drugs. see more +
-
2022-02-15Zhenhai Refinery's Polybutene-1 Industrial Demonstration Plant Produces Qualified Products
On February 8, Sinopec's "Ten-train" research project, the thousand-ton high-grade polybutene-1 industrial demonstration plant, produced qualified products and achieved stable operation, marking that Zhenhai Refinery has made great achievements in the field of high-end synthetic new materials. progress. see more + -
2022-02-15Crude oil to ethylene: just like "wheat" directly making "bread"
In 2021, Sinopec's "Ten-Train" key research project "Technology Development and Industrial Application of Light Crude Oil Cracking to Ethylene" successfully completed the industrialization test in Tianjin Petrochemical, achieving a breakthrough in the domestic industrial application of crude oil steam cracking technology. see more + -
2022-02-15How can fine chemicals take the road of independent research and development?
According to the "2018 China Petroleum and Chemical Industry Economic Operation Report" issued by the China Petroleum and Chemical Industry Federation, there were 1,494 fewer enterprises above designated size in the industry last year, with a total profit of 839.38 billion yuan, an increase of 32% over the previous year. Is the result happy or sad? see more +
Yichun Shanggaoyuan Dali Chemical Co., Ltd.
Service Hotline:
company address:
Jindui Industrial Park, Shanggao County, Jiangxi Province
Copyright: Yichun Shanggaoyuan Dali Chemical Co., Ltd. 赣ICP备2021011172号-1 SEO
