Development and Validation of Stability Indicating RP-HPLC Method for the Determination of Process and Degradation-Related Impurities in Sugammadex Sodium Drug Substance

The aim of this study is to develop and validate a sensitive and specific stability-indicating reversed-phase high-performance liquid chromatographic (RP-HPLC) method for the quantitative determination of Sugammadex sodium together with its process and possible degradation impurities. The pKa value is 2.82. The chromatographic conditions have been optimized by the Hypersil Gold 250 mm X 4.6 mm, 3 µ RP-18 columns with gradient elution using a mobile phase composed of 0.1% phosphoric acid, acetonitrile, and methanol. The eluents were monitored at 205 nm with a flow rate of 1.0 mL/min with an injection volume of 20 µL. The optimized method produced symmetrical and sharp peaks with good separation between the process and degradation impurities. The forced degradation study was carried out under acid, base, oxidation, and thermal conditions to demonstrate the stability-indicating capability of the method. The method was validated as per the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Q2 (R1) and showed excellent specificity, precision, linearity, accuracy, and robustness. The developed HPLC method was precise with a value of 0.25%. The relative standard deviation of accuracy represented by the recovery studies ranged between 89.5% and 104.6%. Linearity analyses indicated a correlation coefficient value of greater than 0.996 for Sugammadex and its known impurities. The LOD and LOQ values for Sugammadex ranged from 0.017% to 0.050%, and for its related impurities, they ranged from 0.015% to 0.055%. The stability of the analytical solution was evaluated and was stable for 75 h when stored at 5 °C. No chromatographic interference was observed during the degradation studies and also in the blank chromatogram.

     

Lighting the Path: Light Delivery Strategies to Activate Photoresponsive Biomaterials In Vivo

Photoresponsive biomaterials are experiencing a transition from in vitro models to in vivo demonstrations that point toward clinical translation. Dynamic hydrogels for cell encapsulation, light-responsive carriers for controlled drug delivery, and nanomaterials containing photosensitizers for photodynamic therapy are relevant examples. Nonetheless, the step to the clinic largely depends on their combination with technologies to bring light into the body. This review highlights the challenge of photoactivation in vivo, and presents strategies for light management that can be adopted for this purpose. The authors’ focus is on technologies that are materials-driven, particularly upconversion nanoparticles that assist in “direct path” light delivery through tissue, and optical waveguides that “clear the path” between external light source and in vivo target. The authors’ intention is to assist the photoresponsive biomaterials community transition toward medical technologies by presenting light delivery concepts that can be integrated with the photoresponsive targets. The authors also aim to stimulate further innovation in materials-based light delivery platforms by highlighting needs and opportunities for in vivo photoactivation of biomaterials.     

Un nouveau regard sur la société virtuelle

The importance of rigorous research into the actual impact of the new Information and Communication Technologies (icts) on society in general cannot be overemphasised. The answer to questions concerning the precise effect ofiCTs on interpersonal relations, communication, social inclusion and exclusion, trust and identity are now central to discussion in both commercial and business fora. This paper examines the concept of the “virtual society“ in the light of the findings of the ESRC (Economic and Social Research Council) Virtual Society? Programme (1997–2002). The paper describes the need to rethink the actual approaches used in researching this area of social science at the same time as performing the analyses themselves. The author also highlights the requirement for future research to examine actual on the ground experiences. How are new technologies actually used and by whom? In addition, the author utilises his overview of this large body of research to put forward a useful guide for predicting the use of ICTs in practice. These “5 rules of virtuality” serve as pointers to the experiences that may be encountered in the development and implementation of new technologies.     

WiMedia UWB 技术追踪

采用WiMedia UWB标准的越来越多 WiMedia通用无线电平台是实现传输速率高达480Mb／s（更高的传输速率正在开发中）无线个人局域网（WPAN）的基础。这个平台并不局限于某一类应用，而是允许同时存在不同的协议适配层，如图1所示。WiMedia规范既规定了一些如无线USB之间相互通信的应用，也规定其他不相互通信的接口同时存在的应用。     

Effect of the Twisting Motion on the Nonunifornities of Transmyocardial Fiber Mechanics and Energy Demand A Theoretical Study

The contraction of the left ventricle (LV) is manifested by a distribution of strains and strain rates throughout the muscle thickness. Using a nested shell spheroidal model of the LV, which accounts for a fiber angle distribution from + 60°at the endocardium to ?60° at the epicardium, and the radial electrical activation pattern from the endocardium to the epicardium, it can be shown that endocardial layers undergo higher strains than the epicardial layers throughout the cardiac cycle, and higher length changes characterize the endocardial sarcomeres relative to the epicardial sarcomeres. However, the calculated nonuniformities in the sarcomeres' shortening are significantly moderated when the physiological twisting motion of the LV around the longitudinal axis is accounted for. Thus, the twisting motion of the heart is a basic mechanism by which the sarcomere function is maintained within its physiological range.