Views: 70 Author: Site Editor Publish Time: 2023-03-21 Origin: Site
The quality standards of pharmaceutical intermediates mainly include indicators such as purity, content, and impurities. Wherein, purity refers to the content of the target compound in the intermediate, and impurity refers to the content of incompletely reacted raw materials, by-products or other impurities in the intermediate. Content refers to the content of various components in the intermediate.
The production process of intermediates involves reaction conditions, reactor types, and reaction control. The characteristics and advantages and disadvantages of different production processes are as follows:
(1) Traditional chemical synthesis method: Traditional chemical synthesis method is a commonly used method in the production of intermediates at present, with mature technology and high production efficiency. However, the discharge of waste water and waste gas from traditional chemical synthesis methods has a certain impact on the environment, and there are certain safety hazards.
(2) Biological method: Biological method is a new type of intermediate production process developed in recent years, which has the advantages of mild reaction conditions and high purity of reaction products. However, the production cost of the biological method is relatively high, and the reaction process is relatively complicated.
(3) Green synthesis method: The green synthesis method is an environmentally friendly and sustainable intermediate production process, which has the advantages of mild reaction conditions, high purity of reaction products, and low impact on the environment. However, the research and development of the green synthesis method is relatively difficult, and the production efficiency is relatively low.
(1) Purity: It can be detected by analytical methods such as chromatography and mass spectrometry. Generally speaking, the purity of intermediates should reach 99%! To (MISSING) above, in order to ensure the quality and curative effect of medicines.
(2) Content: The detection method of content usually adopts methods such as high performance liquid chromatography (HPLC). The content of intermediates should be accurate to ensure that the content of the drug can be controlled during the production process of the drug.
(3) Impurities: Impurities usually include organic impurities, inorganic impurities, moisture, etc. Detection methods can be gas chromatography, solvent extraction, specific rotation and other methods. The impurities of intermediates should meet the standard to ensure the quality and curative effect of medicines.
In order to select an intermediate that meets the criteria, the following aspects need to be considered:
(1) Select a reputable and powerful intermediate manufacturer to ensure that its production process complies with relevant regulations and standards for pharmaceutical production such as GMP.
(2) Manufacturers of intermediates are required to provide complete quality assurance documents and test reports to ensure that intermediates meet relevant quality standards.
(3) Establish a stable supply chain to ensure timely supply and stable quality of intermediates.
(4) Establish a complete intermediate testing system to test each batch of intermediates to ensure that they comply with relevant regulations and standards for pharmaceutical production.
The detection methods and standards of pharmaceutical intermediates are important means to ensure the quality of pharmaceutical intermediates. Commonly used intermediate detection methods include high performance liquid chromatography, gas chromatography, infrared spectroscopy, ultraviolet spectrophotometry, mass spectrometry, etc.
The detection standards of intermediates generally include quality standards, purity standards, safety standards, etc., among which quality standards are the core of intermediate detection, including physical properties, chemical properties, heavy metal element content, etc.
In order to ensure the accuracy of intermediate test results, the following requirements need to be followed:
(1) Strictly control the testing conditions: The testing of intermediates needs to determine the appropriate testing conditions, including sample preparation, testing environment, instruments and equipment, etc. During the testing process, factors such as temperature, humidity, and pressure need to be strictly controlled to ensure the reliability and accuracy of the testing results.
(2) Select the appropriate detection method: select the appropriate detection method according to the characteristics and needs of the intermediate, and analyze and judge according to the detection results.
(3) Ensure the representativeness of the sample: the detection of intermediates needs to ensure the representativeness of the sample, that is, the sample should be fully mixed to avoid inhomogeneity in the sample. At the same time, the collection, storage and processing of samples also need to meet the corresponding specifications and requirements.
Ningbo Nuobai Pharmaceutical Co., Ltd. was formerly known as Ninhua Group Pharmaceutical Business Division (started in 1987 as a part-time Vice President unit of China Chamber of Commerce of Medicines & Health Products Importers & Exporters). In 2017, after completing the third reform, the Group established Ningbo Nuobai Pharmaceutical Co., Ltd, i.e. a subsidiary of Zhejiang Langhua Pharmaceutical Co., Ltd. specializing in the import and export of pharmaceutical products.
With more than 30 years of international operation, the Company has set up a strong and perfect supplier network and overseas sales platform. Its business covers the fields of fine chemicals, pharmaceutical intermediates, bulk drugs, western pharmaceutical preparations and medical consumables and devices, and its products are sold all over the world. Its brand SINING also enjoys high reputation in Africa, Southeast Asia, South America and other international markets.
The Company has always been market-oriented and focused on customer satisfaction. While ensuring reliable, stable supply and cost-effective products, it strives to create value for customers by providing professional compliance solutions such as supply chain management, due diligence, third-party audit, GMP and EHS training and promotion, and drug registration at home and abroad.
Due to its high-quality products and services, the Company was selected as one of “Top 100 Pharmaceutical Internationalized Enterprises - Quality Suppliers and Partners in the International Market” by China Chamber of Commerce of Medicines & Health Products Importers & Exporters in 2019.