Green Strategies toward Eco-Friendly HPLC Methods in Pharma Analysis

The global need for changing the processes in order to meet the green analytical chemistry (GAC) criteria is a great challenge for the pharmaceutical industry. High-performance liquid chromatography (HPLC), as one of the most frequently used techniques in various stages in the pharmaceutical industry, generates huge amounts of organic toxic waste. Therefore, the implementation of the GAC principles in pharma analysis is highly required. Although the number of published papers concerning green chromatography approaches is constantly increasing, the use of eco-friendly HPLC methods in the pharma industry has not been widely implemented. The reasons for this mainly include the need for adaptation of the conventional HPLC instruments, lack of time, lack of experience, or uncertainty of the analysts regarding fulfillment of the method criteria. In this chapter, an overview of green strategies that can be easily applied to conventional instruments for liquid chromatography (LC) in developing eco-friendly HPLC methods in pharma analysis is given. The aim is to emphasize that the green method development in pharma analysis can be easily accomplished and to encourage the analytical community in the pharmaceutical industry not only to develop but also to transfer the already established conventional HPLC methods into green ones

I belong to a Muslim family but I´m not religious : Some young people´s changed view of their religion in Sweden

It is not surprising that the massive Syrian and Afghanistan immigration three years ago, has changed their view towards Islam rules in their new identity creating. But what has been changed? That was my first question in this essay and the answers I got was rules concerned alcohol, prayer, mosque visits and food rules. All this rules requires someone to influence them to take a stand, which lead us to the next question, about how hegemony was exhibited as a factor in how my respondents answered the first question. The theory of hegemony was the analysis instrument of this study and gave me a hypothesis that hegemony probably had something to do with the change of rules, and it had. All these things that I mentioned as changed rules in their new land demands a personal asset and to be legitimized by someone who represents the hegemony.  In order for the hegemony to continue it has to be anonymous and lead for example friends or teachers. It is visible how my respondents talked about matters that had to do with how the changes where in their common sense, where probably hegemony has the strongest attachment, but also how they thought that they made own choices, was also the choice that the hegemony had done before them. Although I took into account the need to be a part of a group, here it showed how the Muslims was included in a group that only had premises from hegemony standard points. The answers for my result was given to me by six secondary school students by semi structured interviews.

The Republic of Macedonia: An Atypical Balkan Country

Geographically and historically, the Republic of Macedonia is part of the Balkans, a region marked by conflict and tension. The centuries that it stood amidst civilizations and empires have enriched this corner of Europe with traditions and cultures. Despite their originality and creativity, however, the nations of the Balkans have never succeeded to stand on their own feet either economically or politically

Reorientation of scope of OMCL API Working Group - Change of focus of future MSS and MSSFP studies

NA</p

Den svaga länken? : Övergång från förberedelseklass till ordinarie klass för den nyanlända eleven

Studiens syfte är att närmare undersöka hur den nyanlända eleven övergår från en förberedelseklass till en ordinarie klass. Den tittar också på vad övergången kan innebära för elevens identitet och fortsatta skolgång. Vidare är syftet med studien att närmare undersöka på vilka grunder som lärarna tar besluten och hur organisationen kring övergången ser ut. Metoden som användes för att nå fram till resultatet var i form av kvalitativa intervjuer på fyra högstadielärare i Kalmar län. Resultatet visade att det inte finns någon enhetlig kartläggning- och bedömningsmaterial för lärarna att utgå ifrån, där mycket av arbetet skedde på individuella och godtyckliga grunder. Vidare har resultatet visat att organisationen på skolorna varierar och att den nyanlända eleven oftast placeras i åtskilda verksamheter på skolorna. Lärarna som arbetar i förberedelseklasserna tenderar att bedöma eleven utifrån dess individuella egenskaper, där de lyfter upp ämneskunskaper, språket och socialiseringen som viktiga segment för elevens utslussning till den ordinarie klassen. Utifrån lärarnas perspektiv framkommer det också att elevens fortsatta skolgång oftast är beroende av hur den mottas i den nya klassen av både lärare och klasskamrater.

The strategic change of the API fingerprint programme: from verification of authenticity of API sources to identifying potential quality issues

Since its creation the API-surveillance programme, performed under the hospices of the API-working group, focused a lot on the authenticity of APIs and the detection of falsified or substandard ones, due to the risks related to the quality of the finished product. With this vision the fingerprint programme was created, where next to conformity analysis to Ph. Eur. Monographs, other types of analysis were performed in order to obtain data, allowing to distinct the different API samples according to their origin or manufacturer. The idea was to obtain a “fingerprint” of the different manufacturer, allowing authenticity checks of suspicious API samples in the&nbsp;future. After feedback from the network and discussions within the API-Working group, it was decided to change the focus of the API-surveillance programme to quality surveillance and detection of potential quality issues. Therefore the future approach would combine conformity analysis to the Ph. Eur. Monographs with fingerprint studies. Though the latter would be focused on deviating samples and&nbsp; manufacturers, where an inconsistent batch reproducibility could be observed. Pattern recognition techniques would be applied first to group the different manufacturers and select those producers for which deviating samples or inconsistencies are observed. In a second step, pattern recognition techniques for only the samples of the selected manufacturers will be performed to conduct an in depth investigation. The working group identified two approaches for the future MSSFP studies: the first is the parallel approach, where conformity analysis and fingerprint study are performed in parallel and the second is the two-step approach, where the results of the conformity analysis, could trigger the launch of a fingerprint study. The parallel approach is the first choice for the members of the API-working group, due to its advantages in the sampling phase and its&nbsp;flexibility. The API-surveillance position paper PA/PH/OMCL (12) 51 was revised to reflect the new approach and strategy. The changes were presented for discussion together with some examples of results of the past MSSFP studies, supporting the new&nbsp;approach.</p

OMCL testing and the API working group: Part of the solution?

Within the OMCL network different initiatives were taken to augment the analysis and market surveillance of APIs used by different manufacturers. Despite the efforts, API testing within the network is limited, compared to the surveillance of finished products. Though it has to be said that the risk for quality deficiencies and falsification of APIs is real and was shown by several crisis. Therefore the API-WG organizes atypical market surveillance studies (MSS), where an MSS (analysis according to the Ph. Eur.) is combined with a fingerprint study (MSSFP). An MSS, according to Ph. Eur. only gives an indication of the quality of the product on some distinct parameters, often chosen based on the manufacturing process. A MSSFP study allows to obtain a global image of the sample, to compare to the batches of the (presumed) manufacturer and/or to the data of fingerpint studies performed in the past in order to detect&nbsp;falsifications. In the presentation the new concept of the combined CAP/MSS/MSSFP studies is presented as well as a summary of the first MSSFP study of this kind on sildenafil citrate (MSSFP004) and this for both the set-up of the study as the obtained results, the conclusion and the lessons&nbsp;learned. Further the ongoing MSSFP005 study on tadalafil is introduced and some future perspectives for API-fingerprint studies within the OMCL network are&nbsp;discussed.&nbsp;</p