News & Updates | Tentamus

Jan 27, 2023 PFAS in juices? The possibility of PFAS entering the juice with the added water during the redilution of concentrates cannot be excluded ➤ Find out more in this blog article

Jan 26, 2023 Symbiotic Research: Determination of Nitrosamine Impurities as Chemical Contaminants in GMP Drug Product-Metformin Symbiotic Research on Utilization of Ultra Performance Liquid Chromatography-Atmospheric Pressure Chemical Ionization-High Resolution Mass Spectrometry (UPLC-

Jan 10, 2023 Reduction of limits for prohibited substances chloramphenicol and nitrofurans (additionally newly demanded: Nifursol) The “minimum performance limits” (MRPL) for the prohibited antibiotic substances chloramphenicol (MRPL = 0.3 ppb) and nitrofuran metabolites (MRPL = 1.0 ppb) in animal foods such as honey, which have been in force in the EU for many years, have been replaced by “reference points for action” (RPA) and tightened significantly. The new RPA are valid since 28.11.2022 (COMMISSION REGULATION (EU) 2019/1871 of 7 November 2019 on reference points for action for non-allowed pharmacologically active substances present in food of animal origin and repealing Decision 2005/34/EC): • New RPA Chloramphenicol = 0.15 µg/kg (ppb)• New RPA Nitrofurans and their metabolites = 0.5 µg/kg (ppb)• Newly included is the nitrofuran Nifursol and its metabolite DNSH (3,5-dinitrosalicylic acid hydrazide) Art. 5 of Regulation (EU) 2019/1871 is especially relevant for the enforcement:Food of animal origin, containing residues of a pharmacologically active substance in a concentration at or above the reference point for action, shall be considered not to comply with Union legislation and shall not enter the food chain. Food of animal origin containing residues of a pharmacologically active substance in a concentration at a level below the reference point for action shall not be prohibited from entering the food chain. QSI has expanded the nitrofuran method scope (previously SEM, AOZ, AMOZ and AHD) to include the metabolite DNSH in accordance with the new regulatory requirements.QSI already offers the analysis of chloramphenicol and the nitrofuran metabolites with sufficiently sensitive limits of quantitation (LOQ) below the new reference points for action (RPA).Choices for chloramphenicol include two LC-MS/MS confirmatory methods with 0.1 ppb LOQ and 0.05 ppb LOQ, and a screening ELISA assay with 0.1 ppb LOQ.Together with the other amphenicols thiamphenicol and florfenicol (no prohibited substances, LOQ remains at 0.3ppb), chloramphenicol is now only available with the two low LOQ´s 0.1 ppb and 0.05 ppb, respectively.Two LC-MS/MS confirmatory methods with 0.5 ppb LOQ and 0.2 ppb LOQ are available for the five nitrofuran metabolites.Additional Information (pdf-file) is automatically issued for confirmed positive LC-MS/MS results of prohibited substances from ½ LOQ, so that you as a customer are also reliably informed about results below the LOQ (optionally de-selectable).The codes with limits of quantitation (reporting limits) on the obsolete MRPL have been decommissioned, as they are no longer sufficiently sensitive for legal evaluation in the EU. Please do not hesitate to contact us with any questions or for a quote – we look forward to actively supporting your company! Email: info.qsi@tentamus.com+49 (0) 421-596607-0Contact

Jan 9, 2023 Frozen herb mixtures - flavors in the kitchen including pyrrolizidine alkaloids and germs Ökotest tested frozen herb mixtures and found pyrrolizidine alkaloids and germs in some cases ➤ Learn more here

Dec 21, 2022 Mycotoxins in wheat Mycotoxin in wheat ➤ Read more and contact our team!

Dec 21, 2022 Analyst Reports Successful GMP FDA Audit with No 483s Analyst Research Laboratories - A Tentamus Company - is a GCLP, GMP and GLP accredited, FDA-inspected contract laboratory ➤ Learn more about their recent FDA GMP Audit here

Dec 19, 2022 Environmental labeling of packaging: approaching the final deadline From 2023 new packaging produced in Italy shall be compliant with the Decree No. 116 of 3 Sep 2020 ➤Tentamus Agriparadigma can help its customers to verify the compliance of their packaging to these new requirements

Dec 9, 2022 EU Health Ministers support proposal to extend transition period for medical devices Due to the known problems with the implementation of the Medical Devices Regulation (EU) 2017/745 (in short: MDR) as well as the Medical Devices Regula

Dec 5, 2022 Update of the GMP+ certification at bilacon Update of GMP+ certification at bilacon ➤ Read more and contact our team!

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