Impurity reference substances can be said to be the driving force of scientific researchers and pharmaceutical companies to monitor drug quality and drug innovation and development, and can steadily promote the active development of drug quality. Therefore, it is of great concern when choosing, what should be paid attention to when choosing impurity reference materials, and where can I find quality suppliers? Let's take a look.

　　Before talking about the impurity reference substance, let me explain two concepts, the reference substance and the impurity reference substance. Reference substance refers to the standard substance used for identification, inspection and content determination, including impurity reference substance. There are two main sources of drug impurities. One is the impurities introduced during the production process, and the impurities generated during the synthesis process. Because the raw materials are impure or the reaction is not complete, the impurities that cannot be completely removed during refining, including the initial Materials, intermediates, isomers, metal impurities, etc.; the second is impurities generated during storage. After drugs are exposed to temperature, humidity, light and air, hydrolysis, oxidation, decomposition, isomerization, polymerization, etc. may occur. Deliquescence, mildew, etc.

　　The important by-product impurities produced in the conventional production process of the impurity reference substance can generally be obtained from USP, EP, LGC, etc., but most of the other impurities need to be synthesized or extracted by themselves. Such impurities are not readily available In the case of standard or reference substances, such impurities should require the establishment of analytical methods, method verification, and calibration according to the registration management regulations, before the content of impurities in the bulk drug can be more accurately quantified.

　　When choosing an impurity reference substance, you need to pay attention to the purity, shelf life, map COA, and supplier qualifications. Purity is the core factor that determines the quality of the control. The long shelf life indicates that its quality is stable. The complete COA of the map and the qualification of the CNAS laboratory are an important indicator for considering the supply unit.

　　Where can I find a good supplier of impurity reference substances?

　　First of all, I suggest that friends choose high-quality impurity brands to obtain satisfactory impurity reference substances. TOSUN PHARM is outstanding in the impurity reference substance industry and has a unique development and analysis method for impurity research. It is the pioneer of impurity reference substances in China and has many years of richness. experience.

　　In addition, TOSUN PHARM has a high-tech R&D team that optimizes the design of drug synthesis and simplifies the synthesis steps while ensuring the quality of impurities; plus internationally qualified CNAS laboratories and complete testing equipment to accelerate the synthesis of impurities .

　　Today, TOSUN PHARM can provide one-stop services such as impurity reference substance, reference preparation import, imported API registration, consistency evaluation and pharmaceutical research services, which fully assists the research and development of pharmaceutical companies and scientific research.