This study evaluated the anaerobic digestion suitability of bio-waste from different sources by comparing their biochemical methane potential (BMP), biodegradability (BI), and content of contaminants (heavy metals and physical impurities) - an often-overlooked factor but one of particular concern in bio-waste. Predominant heavy metals included Cu and Zn, while recurring physical impurities comprised plastics and organic non-biodegradable matter. Food waste from food processing plants were most suitable, exhibiting low contamination and high biogas conversion (BMP>549 NmLCH4/gVS and BI>86 %). Conversely, organic fractions from mechanical biological treatment were highly contaminated, while green waste displayed low biogas conversion (BMP<368 NmLCH4/gVS and BI<72 %). Food waste from households and medium/large-sized producers also demonstrated high biogas conversion, but variable contamination levels could compromise their suitability. Assessing contaminants alongside BMP and BI provides a comprehensive approach for selecting suitable bio-waste feedstocks that can be introduced in biogas plants.

The finding of N-nitrosodiethylamine (NDEA) and N-nitrosodimethylamine (NDMA) in marketed drugs has led to implementation of risk assessment processes intended to limit exposures to the entire class of N-nitrosamines. A critical component of the risk assessment process is establishing exposure limits that are protective of human health. One approach to establishing exposure limits for novel N-nitrosamines is to conduct an in vivo transgenic rodent (TGR) mutation study. Existing regulatory guidance on N-nitrosamines provides decision making criteria based on interpreting in vivo TGR mutation studies as an overall positive or negative. However, point of departure metrics, such as benchmark dose (BMD), can be used to define potency and provide an opportunity to establish relevant exposure limits. This can be achieved through relative potency comparison of novel N-nitrosamines with model N-nitrosamines possessing robust in vivo mutagenicity and carcinogenicity data. The current work adds to the dataset of model N-nitrosamines by providing in vivo TGR mutation data for N-nitrosopiperidine (NPIP). In vivo TGR mutation data was also generated for a novel N-nitrosamine impurity identified in sitagliptin-containing products, 7-nitroso-3-(trifluoromethyl)-5,6,7,8-tetrahydro-[1,2,4]triazolo-[4,3-a]pyrazine (NTTP). Using the relative potency comparison approach, we have demonstrated the safety of NTTP exposures at or above levels of 1500 ng/day.

In this study, the impact of ethylene oxide, propylene oxide, 1,2-butene oxide, and 1,2-pentene oxide on the polymerization of propylene at an industrial level was investigated, focusing on their influence on the catalytic efficiency and the properties of polypropylene (PP) without additives. The results show that concentrations between 0 and 1.24 ppm of these epoxides negatively affect the reaction\'s productivity, the PP\'s mechanical properties, the polymer\'s fluidity index, and the PP\'s thermal properties. Fourier transform infrared spectroscopy (FTIR) revealed bands for the Ti-O bond and the Cl-Ti-O-CH2 bonds at 430 to 475 cm-1 and 957 to 1037 cm-1, respectively, indicating the interaction between the epoxides and the Ziegler-Natta catalyst. The thermal degradation of PP in the presence of these epoxides showed a similar trend, varying in magnitude depending on the concentration of the inhibitor. Sample M7, with 0.021 ppm propylene oxide, exhibited significant mass loss at both 540 °C and 600 °C, suggesting that even small concentrations of this epoxide can markedly increase the thermal degradation of PP. This pattern is repeated in samples with 1,2-butene oxide and 1,2-pentene oxide. These results highlight the need to strictly control the presence of impurities in PP production to optimize both the final product\'s quality and the polymerization process\'s efficiency.

This article is a continuation of work on the use of plastic waste (such as PP, PS, LDPE, HDPE, and their mixtures) processed in the proprietary pyrolysis process as asphalt additives. The article carried out detailed tests of the mixes of selected additives with pen-graded bitumen 50/70, taking into account, among others, the influence of impurities and the ratio of PE to PP in the additives as well as short- (RTFOT) and long-term (RTFOT + PAV) ageing. An extensive research program was carried out, including functional and rheological tests in a wide range of temperatures. First, tests of stability and adhesion to various types of aggregates were carried out, demonstrating the usefulness of the proposed additives. Then, the elastic recovery and the impact of technological ageing on penetration, Fraass breaking temperature, and plasticity range were assessed. The same binder mixes were subjected to rheological tests in a wide range of technological and operational temperatures, assessing, among others, viscosity, the norm of the complex shear modulus, elastic recovery and compliance in the MSCR test, and stiffness in the bending beam rheometer. This entire class of tests was carried out for clean samples and those containing impurities, indicating their impact on individual material parameters.

The presence of impurities in active pharmaceutical ingredients (APIs) and drug products represents a risk to patients\' health. Such substances are related to diverse side effects and may have mutagenic potential. That\'s why it is necessary to establish acceptable limits for these by-products, to minimize the risk associated with medicinal therapy. This work focused on presenting a critical review of relevant points related to the presence of impurities in pharmaceuticals. The main legislation and guidelines from the FDA, EMA, ICH, and Pharmacopeias about the subject were evaluated, and recent articles related to the topic were searched in Scopus, ScienceDirect, PubMed, and Web of Science from 2013 to 2023. Additionally, the analytical techniques used for quantifying impurities were discussed, along with relevant tests for assessing the toxicological and mutagenic risks of these by-products. Recent legislation, including ICH Q3A (R2), ICH Q3B (R2), ICH M7 (R2), ICH Q3D (R2), ICH Q3C (R9), ICH Q3E, ICH Q6A, ICH M3 (R2), as well as FDA and EMA guidelines, highlights a comprehensive and effective framework for controlling impurities in pharmaceuticals. Despite this, there remains a lack of harmonization and standardized procedures across different regions. From the review of scientific literature, we observed that advancements in analytical techniques have significantly improved the sensitivity and selectivity in detecting impurities and degradation products. This underscores the ongoing commitment of health agencies and the pharmaceutical industry to ensure the safety and efficacy of medicinal products.

In this study we analyzed drug recall data from the U.S. Food and Drug Administration (FDA) over the period 2012-2023. We identified trends in the number of recalls initiated annually and their underlying causes. On average, 330 drug recalls are initiated each year, showing an overall increasing trend. The average duration of a recall, from initiation to termination date, was 1.3 years and each recall involved on average 400 000 product units, implying considerable resource demands and consequences for all stakeholders. The most frequent cause of these recalls was found to be impurities and contaminants (37 %), followed by control (28 %) and labeling/packaging (19 %) issues. Recalls of medicines causing serious health problems or death (class I), accounted for 14 % of the recall events. Continuous evaluation of recalls is expected to reduce their number, mitigate their impact on the healthcare system and improve drug safety.

Carbide slag (CS) is a kind of solid waste generated by the hydrolysis of calcium carbide for acetylene production. Its major component is Ca(OH)2, which shows great potential in CO2 mineralization to produce CaCO3. However, the types of impurities in CS and their mechanisms for inducing the morphological evolution of CaCO3 are still unclear. In this work, the influence of impurities in CS on the morphology evolution of CaCO3 was investigated. The following impurities were identified in the CS: Al2O3, MgO, Fe2O3, SiO2 and CaCO3. Ca(OH)2 was used to study the influence of impurities (Al2O3 and Fe2O3) on the evolution of CaCO3 morphology during CS carbonation. Calcite (CaCO3) was the carbonation product produced during CS carbonation under varying conditions. The morphology of calcite was changed from cubic to rod-shaped, with increasing solid-liquid ratios. Moreover, rod-shaped calcite was converted into irregular particles with increasing CO2 flow rate and stirring speed. Rod-shaped calcite (CaCO3) was formed by CS carbonation at a solid-liquid ratio of 10:100 under a stirring speed of 600 rpm and a CO2 flow rate of 200 ml/min; and spherical calcite was generated during Ca(OH)2 carbonation under the same conditions. Al2O3 impurities had negligible effects on spherical CaCO3 during Ca(OH)2 carbonation. In contrast, rod-shaped CaCO3 was generated by adding 0.13 wt% Fe2O3 particles, similar to the content of Fe2O3 in CS. Rod-shaped calcite was converted into particulate calcite with increasing Fe2O3 content. The surface wettability and surface negative charge of Fe2O3 appeared to be responsible for the formation of rod-shaped CaCO3. This study enhances our understanding and utilization of CS and CO2 reduction and the fabrication of high-value rod-shaped CaCO3.

The development of stable and selective electrocatalysts for converting CO2 to value-added chemicals or fuels has gained much interest in terms of their potential to mitigate anthropogenic carbon emissions. Most of the electrocatalysts are tested under pure CO2; however, industrial outlet flue gas contains numerous impurities, such as NO and SO2, which poison the electrocatalysts and alter the product selectivity. Developing electrocatalysts that are resistant to such impurities is essential for commercial implementation. Herein, we prepared bilayer porous electrocatalysts, namely, Sn, Bi, and In, on porous Cu foam mesh (Sn/Cu-f, Bi/Cu-f, and In/Cu-f) by a two-step electrodeposition process and employed these electrodes for the electrochemical reduction of CO2 to formate. It was observed that the bilayer porous electrocatalysts exhibited high CO2 reduction activity compared to catalysts coated on a Cu mesh. Among bilayer porous electrocatalysts, Sn/Cu-f and Bi/Cu-f electrocatalysts showed more than 80% faradaic efficiency (FE) toward formate production, with a formate partial current density of around -16 and -10.4 mA cm-2, respectively, at -1.02 V vs RHE. In/Cu-f electrocatalyst showed nearly 40% formate FE with formate partial current density of -15 mA cm-2 at -1.22 V vs RHE. We investigated the effect of NO and SO2 impurities (500 ppm of NO, 800 ppm of SO2, and 500 ppm of NO + 800 ppm of SO2) on these electrocatalysts\' selectivity and stability toward formate. It was observed that the Bi/Cu-f electrocatalyst showed 50 h stability with 80 ± 5% formate FE, and Sn/Cu-f showed 18 h stability with above 80 ± 5% efficiency in the presence of NO and SO2 mixed with CO2. Furthermore, we studied the effect of CO2 concentration with Sn/Cu-f and Bi/Cu-f catalysts in the range of 15-100% CO2, for which formate FEs of 45-80% were observed.

Lentiviral vectors (LVVs) are used as a starting material to generate chimeric antigen receptor (CAR) T cells. Therefore, LVVs need to be carefully analyzed to ensure safety, quality, and potency of the final product. We evaluated orthogonal and complementary analytical techniques for their suitability to characterize particulate matter (impurities and LVVs) in pharmaceutical LVV materials at development stage derived from suspension and adherent manufacturing processes. Microfluidic resistive pulse sensing (MRPS) with additional manual data fitting enabled the assessment of mode diameters for particles in the expected LVV size range in material from adherent production. LVV material from a suspension process, however, contained substantial amounts of particulate impurities which blocked MRPS cartridges. Sedimentation-velocity analytical ultracentrifugation (SV-AUC) resolved the LVV peak in material from adherent production well, whereas in more polydisperse samples from suspension production, presence of particulate impurities masked a potential signal assignable to LVVs. In interferometric light microscopy (ILM) and nanoparticle tracking analysis (NTA), lower size detection limits close to ∼ 70 nm resulted in an apparent peak in particle size distributions at the expected size for LVVs emphasizing the need to interpret these data with care. Interpretation of data from dynamic light scattering (DLS) was limited by insufficient size resolution and sample polydispersity. In conclusion, the analysis of LVV products manufactured at pharmaceutical scale with current state-of-the-art physical (nano)particle characterization techniques was challenging due to the presence of particulate impurities of heterogeneous size. Among the evaluated techniques, MRPS and SV-AUC were most promising yielding acceptable results at least for material from adherent production.

Wastewater serves as a vital resource for sustainable fertilizer production, particularly in the recovery of nitrogen (N) and phosphorus (P). This comprehensive study explores the recovery chain, from technology to final product reuse. Biomass growth is the most cost-effective method, valorizing up to 95 % of nutrients, although facing safety concerns. Various techniques enable the recovery of 100 % P and up to 99 % N, but challenges arise during the final product crystallization due to the high solubility of ammonium salts. Among these techniques, chemical precipitation and ammonia stripping/ absorption have achieved full commercialization, with estimated recovery costs of 6.0-10.0 EUR kgP-1 and 4.4-4.8 £ kgN-1, respectively. Multiple technologies integrating biomass thermo-chemical processing and P and/or N have also reached technology readiness level TRL = 9. However, due to maturing regulatory of waste-derived products, not all of their products are commercially available. The non-homogenous nature of wastewater introduces impurities into nutrient recovery products. While calcium and iron impurities may impact product bioavailability, some full-scale P recovery technologies deliver products containing this admixture. Recovered mineral nutrient forms have shown up to 60 % higher yield biomass growth compared to synthetic fertilizers. Life cycle assessment studies confirm the positive environmental outcomes of nutrient recycling from wastewater to agricultural applications. Integration of novel technologies may increase wastewater treatment costs by a few percent, but this can be offset through renewable energy utilization and the sale of recovered products. Moreover, simultaneous nutrient recovery and energy production via bio-electrochemical processes contributes to carbon neutrality achieving. Interdisciplinary cooperation is essential to offset both energy and chemicals inputs, increase their cos-efficiency and optimize technologies and understand the nutrient release patterns of wastewater-derived products on various crops. Addressing non-technological factors, such as legal and financial support, infrastructure redesign, and market-readiness, is crucial for successfully implementation and securing the global food production.