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Drug-Device-Combinations acc. to article 117 MDR

With the entry into force of the Medical Devices Regulation (EU) 2017/745 (MDR) at the end of May 2021, there have not only been many new and mostly more complex requirements for manufacturers of medical devices. Article 117 MDR also amends Annex I of the Medicinal Products Directive 2001/83/EC on so-called drug-device combinations to the
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Old woman - brain - puzzle - alzheimer

Aducanumab – first new treatment approved for Alzheimer’s since 2003

Alzheimer disease: Alzheimer’s is responsible for 60% of the world’s estimated 50 million dementias. The heterogeneity of the disease makes Alzheimer’s diagnosis and counting the total number of affected people difficult. Every fifth patient has an atypical Alzheimer’s disease, which is often not recognized This progressive neurodegenerative disease starts with microscopic changes in the brain
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Preservation Challenge Tests Cosmetics Tentamus

Preservation Challenge Tests for Cosmetics according to ISO 11930

How can we ensure that a cosmetic product remains stable against microbiological influences?   Preservation challenge tests represent a fundamental building block for evaluating the microbiological safety of cosmetic products. The test is intended to confirm that the cosmetic product prevents germ multiplication when used as intended and is therefore microbiologically stable. The ISO 11930
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Fragrances Cosmetics Tentamus

New Regulations for Fragrances in Cosmetics

The field of analysis and declaration of allergenic fragrances in cosmetics is currently in a state of flux. In general, certain fragrances a certain amount in cosmetics have to be declared above (according to Annex III of Regulation (EC) No. 1223/2009: 10ppm for leave-on products, 100ppm for rinse-off products), the use of individual fragrances is even
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New Method: Analysis of amino acids in feed and food via LC-LRMS/MS

For a healthy diet and the functionality of biological processes, humans and animals need amino acids. Laboratories often face the problem of challenging analysis when determining the correct content of amino acids in food and feed. Amino acids (AA) are organic molecules that contain both a carboxylic -COOH and an amino -NH2 functional group. In
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Our Pet Food Passion!

Here at Tentamus, we see pets as companions, friends. Just like our human families we want to make sure our animal family is on a natural, healthy diet. Though many people may not realize it, pet food has many similar aspects to human food. Pet food should have a guaranteed analysis of protein, fiber, fat,
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Analysis of ethylene oxide in Rotterdam

The number of recalls for products in which ethylene oxide residues and 2-chloroethanol are detected is increasing every day. In 2020, residues were found in sesame and sesame products, and now ethylene oxide is being detected in locust bean gum, xanthan gum and thickeners. Ethylene oxide is a gaseous disinfectant used to kill fungi and
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Lambda Científica: New member of the Tentamus Group

Lambda Científica, a leading analytical laboratory in the pharmaceutical sector in Mexico with a history of more than 48 years in the industry, enters into a significant alliance with Tentamus Group. Lambda is an independently owned laboratory providing microbiological and chemical analyses for the pharmaceutical industry, in particular supporting their customers in drug analysis, analysis
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Investigational New Drug Approval of Potential COVID-19 Medication by FDA

Highland Park, NJ — Global Coronaviruses (Covid-19) deadly infection has urged the world’s pharmaceutical scientists and global health professionals to accelerate the Covid-19 treatment and vaccine development. EuTech Scientific Services, Inc.’s (EuTech) experienced team has worked hand-in-hand with IHP Therapeutics (IHP) to perform a complete characterization of their biological drug IHP-009 to ensure that it meets FDA regulations.
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