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Risk evaluation of nitrosamines in pharmaceuticals

As of October 2020, EMA and the national competent authorities are asking marketing authorisation holders for metformin-containing medicines to test their medicines before releasing them onto the market. The risk evaluation for chemical medicines should be completed at the latest by 31 March 2021 and 1 July 2021 for biological medicines. If a risk is
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DSI-pharm achieved GMP compliance for 400 MHz-NMR

In October 2020, a complete device qualification of the AscendTM 400 MHz-NMR (Picture 1) used by DSI-pharm was performed to achieve GMP ready status. This was carried out by GMP trained Bruker engineers and included testing the operation of the system to determine that it meets Bruker`s factory specifications as well as testing the computer
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Analysis of cannabis extracts according to DAB monograph

Change of the analysis of cannabis extracts according to DAB monograph

On 1 June 2020, the long-awaited monograph “Cannabis exractum normatum” in the German Pharmacopoeia (DAB) came into force. This monograph provides the basis for a variety of THC and/or CBD cannabis extracts and allows the use of different carrier oils. The monograph “C-054 Adjusted, refined cannabis oil resin” in the German Drug Codex (DAC), which
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Testing the in-use stability of medicinal products

Testing the in-use stability of medicinal products

Your product is in good hands – we test for shelf-life after opening (in-use stability) The shelf life of a medicinal product is indicated by the expiry date. For tablets in blister, the shelf life corresponds to the expiry date indicated on the outer packaging. The situation is different for drugs in containers with the
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Chicken thighs: pathogens spoil the pleasure

Chicken thighs should taste moist, aromatic and tender so that the consumption is a pleasure and not a disappointment. In a recent test, 17 different products were tested and only five were able to convince.   Campylobacter, salmonella, pseudomonads and antibiotic-resistant germs were found   Various pathogens (e.g. Campylobacter) were detected, which cannot be identified
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Making of VelaLabs new Cleanroom

VelaLabs integrated the laboratory LABH in 2020. The laboratory space for microbiology and sterility was reconstructed with Cleanroom Technology Austria. With this brand new facilities and equipment VelaLabs is able to offer a wide range of microbiological services at the highest standards. Watch and see the reconstruction in our video. You want to know more
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4 Food Labelling Challenges Since Brexit

Since Brexit, the UK is now considered a third country. This means that companies exporting from UK to the European Union will have to face different compliance challenges from now on.   Here are 4 challenges to consider:   1. Address on the Label   When exporting to countries within the European Union, it is
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Vegetable baby food tested

The first complementary food is given to babies after about four to seven months, because from this point on milk is no longer sufficient for an optimal nutrition. With vegetable baby food babies get important fiber, vitamins and minerals to help them grow big and strong.   Furan is not part of a healthy diet
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New progress on the stability indexes for EVOOs

Jaén, Spain  Laboratorio Tello together with L.A.B. (both part of Tentamus Group) and the University of Granada, continue to advance in the development of stability indices on extra virgin olive oils and other vegetable oils.   Since 2018, Laboratorio Tello and L.A.B. are working on the public research project CASEITE of the call “RETOS Colaboración 2017″ next to the Analytical Chemistry Research Group FQM-232 (Analysis in Food and Environment of UGR)
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Thiamethoxam banned for use in the UK

Thiamethoxam, a neonicotinoid pesticide, was banned for use by both the UK and the EU back in 2018 due to the adverse effects on bee populations and other pollinators. In recent years it had been approved in the UK for emergency use due to the presence of yellow virus.   Growers of sugar beet in
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Potential dangers of Nitrosamines in Rifampin and Rifapentine

Rifampin and Rifapentine are antibiotics used to treat and prevent tuberculosis or meningococcal disease. The FDA became aware and subsequently released guidance on August 26, 2020, about the potential of nitrosamine impurities in certain samples of Rifampin and Rifapentine. The nitrosamines in question are 1-methyl-4-nitrosopiperazine (MNP) for Rifampin and 1-cyclopentyl-4-nitrosopiperazine (CPNP) for Rifapentine. Both MNP and
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Salmonella in herb mixtures

Recently, Salmonella was detected in several frozen herb mixtures. Salmonella are motile, gram-negative rods that can be consumed by humans through foods. The consumption of food contaminated with salmonella can lead to salmonellosis. Symptoms of salmonellosis are: Diarrhea Abdominal pain Headache Malaise Vomiting Mild fever Foods such as eggs, egg products, ice cream and raw
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Extension and conversion of accreditation

For many years, QSI GmbH holds an accreditation as a testing laboratory for the analysis of food and pharmaceutical raw materials. Regular inspections by the independent German Accreditation Body (DAkkS) provide evidence of the competence of our expert staff, the quality of our analytical results and the suitability of our laboratory equipment. In 2020, the
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