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Top 10 Global CDMO Enterprises| The Meaning of IND, NDA and ANDA| Top 10 Global Clinical Research Organizations in 2021
Oct 13,2021
Key Material Attributes of API Particle Size in Formulation Development
The particle size of the API, as a key material attribute in the development of formulations, not only affects the powder properties of the API (such as fluidity), the uniformity of the formulation content, the chemical stability of the API and the formulation, but also affects the dissolution of the formulation, which in turn affectsRead more
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Oct 13,2021
What are APIs, Original Research Drugs and Generic Drugs?
The bulk drug is a kind of compound, because it is impossible for the compound to have perfect physical and chemical parameters to achieve the greatest effect in the complex environment of the human body, so the regular original research drug needs to use various excipients and dosage forms to achieve the curative effect. ChemicalRead more
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What are APIs, Original Research Drugs and Generic Drugs?
Oct 13,2021
Analysis of the Difference Between Intermediates and APIs
Intermediates refer to intermediate products in the process of compound synthesis. Pharmaceutical intermediates are some chemical APIs or chemical products used in the synthesis process of APIs. They do not require a production license for APIs and can be produced in ordinary chemical plants. , As long as it reaches a certain level, it canRead more
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Analysis of the Difference Between Intermediates and APIs
Oct 13,2021
Four Processes for the Production of API
APIs are the prerequisite for the production of pharmaceutical preparations. In all links of the pharmaceutical industry chain, they play the role of processing and manufacturing basic pharmaceutical industry APIs, and most of them are outsourced production. API drug outsourcing process services refer to pharmaceutical companies entrusting other pharmaceutical R&D institutions to conduct API outsourcingRead more
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Oct 12,2021
Types and Analysis of Residual Solvents in the R&D and Production of APIs
Residual solvents in drugs are defined in Q3C as organic volatile compounds produced or used in the production of bulk drugs or excipients, and during the preparation of the formulations, and they cannot be completely eliminated in the process. In the process of drug substance impurity analysis, the study of residual solvents has attracted muchRead more
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Oct 12,2021
The Selection and Quality Control of the Starting Materials of API
Pharmaceutical preparations are composed of three major elements: qualified raw materials, appropriate amounts of excipients, and scientific production technology. Among them, the quality of raw materials is the first element that affects pharmaceutical preparations. Pharmaceutical outsourcing process institutions can provide outsourcing process R&D and production of intermediates, bulk drugs, preparations, etc. Starting materials are anRead more
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The Selection and Quality Control of the Starting Materials of API
Oct 12,2021
Major Characteristics of the API Production Process
Compared with the production of pharmaceutical preparations, the production process of API drugs has its own characteristics. Because the production process of APIs often includes complex chemical and biological changes, and has a relatively complex intermediate control process, by-products are often produced during the production process, which usually requires a purification process. At present, manyRead more
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Oct 12,2021
Understand Whether the Structure of the Synthetic API is Correct
The preparation and research of APIs is at a critical position in the chemical drug R&D process, and the structure of the prepared compounds is consistent to ensure that subsequent quality control studies, pharmacology and toxicology studies, and clinical studies are meaningful. Through the structure of the synthesized APIs Confirmation can characterize whether the structureRead more
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Understand Whether the Structure of the Synthetic API is Correct
Oct 12,2021
Caco-2 Cell Model of ADME Model in Vitro
The new drug development stage includes 4 important stages: target determination, model establishment, lead compound discovery, and lead compound optimization. After the target is determined, a biological model such as an in vitro ADME model of a drug should be established, which is mainly used to study drug absorption, distribution, metabolism and drug toxicity,
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Caco-2 Cell Model of ADME Model in Vitro
Oct 11,2021
Nine Development Trends of Chemical Synthetic Drugs
As an important part of drug research and development, chemically synthesized drugs are still the subject of new drug research and development for major pharmaceutical companies in the world today. The production of chemical drugs is inseparable from three stages: raw material pretreatment, chemical reaction and product refinement. Chemical drugs can be inorganic minerals orRead more
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Nine Development Trends of Chemical Synthetic Drugs