ISO 10993 Biological Evaluation of Novel Hemostatic Powder – 4SEAL®

Background:Hemostasis plays a crucial role during every surgery allowing for a bloodless operating field. Fast and effective surgery leads to a reduced risk of postoperative complications. One of the latest method for achieving homeostasis is the use of natural polysaccharide-based hemostatic powders. The study aimed to evaluate the biocompatibility according to the ISO 10993 standards of 4SEAL® Hemostatic powder.Methods:Chemical characterization (Headspace GC-MS, GC-MS, and ICP-MS), cytotoxicity, genotoxicity (MLA and AMES), endotoxin contamination, sensitization potential, intracutaneous reactivity, acute and subacute systemic toxicity with implantation, and pyrogenicity were evaluated to investigate the biocompatibility of the 4SEAL® Hemostatic powder. Studies were conducted according to ISO 10993 standards.Results:The biocompatibility requirements with accordance to ISO 10993-1 for 4SEAL® Hemostatic powder were met.Conclusions:4SEAL® Hemostatic powder is a promising new hemostatic agent with a wide range of potential applications and excellent biocompatibility.

Metabolomics Reveals Heterogeneity in the Chemical Composition of Green and White Spears of Asparagus (A. officinalis)

Green and white asparagus are quite different crops but can be harvested from the same plant. They have distinct morphological differences due to their mode of cultivation and they are characterised by having contrasting appearance and flavour. Significant chemical differences are therefore expected. Spears from three varieties of both green and white forms, harvested in two consecutive seasons were analysed using headspace GC-MS and LC-MS with an untargeted metabolomic workflow. Mainly C5 and C8 alcohols and aldehydes, and phenolic compounds were more abundant in green spears, whereas benzenoids, monoterpenes, unsaturated aldehydes and steroidal saponins were more abundant in white ones. Previously reported key asparagus volatiles and non-volatiles were detected at similar or not significantly different levels in the two asparagus types. Spatial metabolomics revealed also that many volatiles with known positive aroma attributes were significantly more abundant in the upper parts of the spears and showed a decreasing trend towards the base. These findings provide valuable insights into the metabolome of raw asparagus, the contrasts between green and white spears as well as the different chemical distributions along the stem.

Method Development for the Control of Potential Genotoxic Impurities in Vigabatrin Using Gas Chromatography Techniques and Mass Spectroscopy Detector

Aim: To develop a sensitive headspace GC-MS method for the determination of potential genotoxic impurities in Vigabatrin. Place and Duration of Study: The study was performed in SIONC Pharmaceuticals, Visakhapatnam from June 2020 to March 2021. Methodology: The impurities were determined by selected ion monitoring mode using VF -WAXms (30 mts length, 0.25 mm internal diameter, 1.0 µ film thickness) column. Helium gas was used as carrier gas with a column flow of 1.0 mL/min. and injector temperature maintained at 220 0C. Oven Temperature, loop temperature and transfer line temperature were maintained in the head space at 70oC, 90oC and 100oC respectively. Results: The linearity of the method was proposed in the range of LOQ to 150 % for the genotoxic impurities by subjecting the data obtained to statistical analysis using linear regression model (r2 > 0.99). The method also gave acceptable recovery of all the four impurities at each level and was found to be accurate. The % RSD obtained in the method precision and intermediate precision were less than 11% depicting the precision of the method. The LOD and LOQ values were calculated based on the signal to noise ratio and are indicating the sensitivity of the method. The specificity of the method was checked for blank interference at the retention time of respective impurities. Conclusion: The results proved that the proposed headspace GC-MS method for the study of potential genotoxic impurities of Vigabatrin was sensitive, precise and accurate and could be routinely used in the quality control testing of the active pharmaceutical ingredient.