Solutions for elemental impurities in chemical reactions

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This post was last edited by Shaobin Fluid on 2026-4-10 at 13:22. The global landscape has undergone profound changes, and supply chain security has been significantly impacted； As the core of the pharmaceutical industry, active pharmaceutical ingredients have always received significant attention from various countries. The Q3D elemental impurity guideline addresses the impurity risks posed by manufacturing equipment, drug substances, excipients, and container closure systems in the final product. Mark Schweitzer, Global Head of Analytical Science and Technology at Novartis, said that pharmaceutical companies must generate their own data, and there is not much data available regarding elemental impurities. We have very little data, but there are huge concerns. In 2023, China’s drug regulatory authority issued the \"Guidelines for Elemental Impurities,\" which analyze the sources of impurities, identify the pathways by which they enter the product, and explore methods to reduce their presence ； Analyze the relationship between related substances and formulation processes, packaging materials, etc., particularly the quality of the active pharmaceutical ingredient, granulation processes, shaping processes, etc., while also considering the relationship between excipients and the degradation of related substances ； Analyze whether various factors such as moisture are related to drug stability and the formation of related substances. Residual elemental impurities, examined in conjunction with the production process ； Special attention is paid to the use of metal catalysts in active pharmaceutical ingredients, as well as other situations where elemental impurities can be introduced ； If other toxic impurities are detected, their toxicological effects should be further considered. Regarding the sources of elemental impurities in the active pharmaceutical ingredient, engineers evaluate each factor in the production process to identify potential sources of such impurities as well as the types of elemental impurities that may be present. The R&D team at AINSTAMTC collaborates with companies such as Bayer, BASF, and Purolite to identify the best solutions in terms of materials, costs, risks, and safety regarding technology and processes. CVI chemical vapor deposition technology for tantalum surface alloying enables improvements in material properties, and it uses the most direct technical approaches to prevent contamination by elemental impurities in the equipment used for producing active pharmaceutical ingredients. This technology addresses the issue of elements such as iron, copper, chromium, manganese, and nickel present in key components of these production systems, including reaction vessels, centrifuges, hydrolysis tanks, titanium rod filters, crushers, and connecting valves and pipes. Chemical properties of metallic tantalum: Metallic tantalum (Ta) possesses excellent chemical properties, with very high corrosion resistance. It shows no reaction to hydrochloric acid, concentrated nitric acid, and aqua regia, whether under cold or hot conditions. When tantalum is immersed in sulfuric acid at 200°C for a year, the surface layer suffers only an erosion of 0.006 millimeters. Experiments have shown that at room temperature, tantalum is inert to alkaline solutions, chlorine gas, bromine water, dilute sulfuric acid, and many other chemicals; it reacts only in the presence of hydrofluoric acid and hot concentrated sulfuric acid. Such a situation is relatively rare in metals. Applications of tantalum in acid equipment: In equipment used for producing various inorganic acids, tantalum can be used as a substitute for stainless steel, offering a service life that is dozens of times longer than that of stainless steel. Tantalum is a material chosen for manufacturing equipment used to handle hot concentrated sulfuric acid. Since tantalum is of considerable importance to the sulfuric acid industry, its corrosion rate in sulfuric acid at a concentration of 96% and a temperature of 210°C is 0.05 ram/a ； For an acceptable corrosion rate, tantalum maintains good passivation properties at 230°C. Tantalum equipment ensures the purity of media and products. Another advantage of tantalum-based equipment is that it guarantees the purity of media and products absolutely. In this regard, in certain industries, especially the pharmaceutical industry, specific manufacturing processes impose very strict requirements on equipment; any wear or leakage is absolutely not allowed, even in highly corrosive environments. To meet this requirement, the range of available devices is very limited. Among all metal materials, aside from glass, enamel, and silicon cast iron, only tantalum is the most suitable. The corrosion rate of 10% acetic acid at 450°F (230°C). The corrosion rate of 10% hydrogen chloride/10% acetic acid/15 psia hydrogen sulfide at 450°F (230°C). The corrosion rate of titanium surface alloys after a certain testing time in wet chlorine, liquid bromine, as well as hot hydrochloric acid, sulfuric acid, and acetic acid was zero, which is consistent with the expectations for titanium. This proves that the tantalum coating is dense and fully covers the underlying stainless steel substrate. Severe mechanical deformation and thermal cycling have no effect on corrosion resistance. This proves that the surface alloy formed on the substrate provides an extremely strong weld between stainless steel and tantalum. The surface alloying makes tantalum surface alloyed products extremely durable compared to other typical coatings, whose bonding is mainly mechanical. The impact resistance and strength test strips are stamped using a Rockwell C conical punch, and U-shaped bends are created with 3/8 in (10 mm) rollers. Oxford Instruments’ wavelength dispersive spectroscopy (WCS) sample type: samples with spiral sections ； Two thin-film detection devices: tungsten filament scanning electron microscope + X-Max energy dispersive spectroscopy; detection parameters: acceleration voltage of 20 kV