Potential mutagenic impurities in Active Pharmaceutical Ingredient, Meropenem Trihydrate were assessed and a novel analytical method for their quantification was developed and validated. This Liquid Chromatographic me...Potential mutagenic impurities in Active Pharmaceutical Ingredient, Meropenem Trihydrate were assessed and a novel analytical method for their quantification was developed and validated. This Liquid Chromatographic method using High Resolution Mass Spectrometer (LC-HRMS) technique is proved to be suitable for simultaneous quantification of all ten identified impurities with required specificity, sensitivity, resolution, precision, accuracy, and other method characteristics as per ICH Guidelines. The acceptable limit of less than 2.9 μg/g was considered for evaluations, based on drug substance dosage and duration of treatment. The method stands most sensitive with a Limit of Detection of 0.35 μg/g, considering the challenge full acceptance criteria as per current regulatory standards.展开更多
This study aims to contribute to development of SHRM field.Because personnel management and human resource management are in practice by firms,however,firms do not apply strategic HRM yet.There are four definitions of...This study aims to contribute to development of SHRM field.Because personnel management and human resource management are in practice by firms,however,firms do not apply strategic HRM yet.There are four definitions of SHRM so far.This study presents a new approach for the development of the field.It is HRM involvement.HRM involvement is related to appointment of managers and board of directors.Because board of directors appoints managers in firms,HR must be member of board of directors.Because managers achieve firm performance(market share and profit),and Board of Directors appoints managers.Therefore,HRM manager must be involved with board of directors to affect appointments.This study uses semantic content analysis and systematic review methods as a research methodology.To conclude,organizations may apply strategic HRM through strategic HR Directors at top level,appointment of C-level Executives and HRM involvement.展开更多
文摘Potential mutagenic impurities in Active Pharmaceutical Ingredient, Meropenem Trihydrate were assessed and a novel analytical method for their quantification was developed and validated. This Liquid Chromatographic method using High Resolution Mass Spectrometer (LC-HRMS) technique is proved to be suitable for simultaneous quantification of all ten identified impurities with required specificity, sensitivity, resolution, precision, accuracy, and other method characteristics as per ICH Guidelines. The acceptable limit of less than 2.9 μg/g was considered for evaluations, based on drug substance dosage and duration of treatment. The method stands most sensitive with a Limit of Detection of 0.35 μg/g, considering the challenge full acceptance criteria as per current regulatory standards.
文摘This study aims to contribute to development of SHRM field.Because personnel management and human resource management are in practice by firms,however,firms do not apply strategic HRM yet.There are four definitions of SHRM so far.This study presents a new approach for the development of the field.It is HRM involvement.HRM involvement is related to appointment of managers and board of directors.Because board of directors appoints managers in firms,HR must be member of board of directors.Because managers achieve firm performance(market share and profit),and Board of Directors appoints managers.Therefore,HRM manager must be involved with board of directors to affect appointments.This study uses semantic content analysis and systematic review methods as a research methodology.To conclude,organizations may apply strategic HRM through strategic HR Directors at top level,appointment of C-level Executives and HRM involvement.
