The Inorganic impurity for injectable WATER ,chemical DRUGS and biopharmaceuticals : Conductivity TOC and Activated charcoal -graphene testing in Quality control-Hypotesys of work (original) (raw)

2024, ISAR Journal of Multidisciplinary Research and Studies

This work is involved inorganic impurity profile in drugs and in biopharmaceuticals : according FDA and EMA for chemical Drugs are Adopted theesholds, below this value they not require identification as mandatory. In order To eliminate pirogen In the production of WIFI water (for injiectable) are used also activate carbon filter and FDA consider this product as a possible source of inorganic impurity. But for Injectable water production to test the quality is required Conductivity measure and Toc total organic carbon assay. In this way WIFI water can be considerdc safe because with this analisys it is possible to exclude both inorganic and organic impurity. In biopharmaceutical purification steps are used also composite material filter (some producer use activated charcoal) and this materials can in teory exfoliate graphite and graphene in mechanical way. (Graphene is a good conductor of elettricity and it is classify as inorganic.) In the final vials of biopharmaceuticals is not requested conductivity test. For chemical drugs there are regulatory requirement for global impurity : if the test show results below the fixed thresholds no more action is required. (no needed identification) , genotoxicity and cancergenicity evalutation are also performed. For biotech product there are not fixed limits for all inorganic molecule (only suggested), instead fixed for elemental impurities and residual solvents : regulatory rules report a responsability of the producer for actions. There are guideline ICH for preclinical study of mutagenicity and cancerogenicity. Aim of this work is to analyze the conductivity and TOC testing role for WIFI water production and its meaning in PAT and to discuss about the need to verify also below thresholds adopted or suggested for molecule like graphene for the drugs substantie produced. In this study are reported various commercial products , but it is not intent of the authors to put in relationship the profile of impurity of the final product using this with any toxicological aspects : this are only reported for a pure Material science purpose. Keywords: Inorganic Impurity, regulatory, purification, activated charcoal, graphite, graphene, cartridge, membrane, monoliths, composite materials, TOC,conductivity, WIFI water, biopharmaceuticals, biological drugs,genotoxicity,mutagenesis, RAMAN spettroscopy, PAT, brief, medium long term toxicity profile, toxicology, material science.