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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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Legalization of cannabis for recreational purposes

QSI is a DAkkS (German Accreditation Body)-accredited and GMP-certified laboratory that can look back on 60 years of expertise in the analysis of food, pharmaceutical products, and pharmaceutical raw materials. We specialize in honey, coffee, industrial hemp, CBD products and cannabis. QSI holds a BtM (narcotics) license and imports cannabis from all countries that currently
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European Pharmacopoeia publishes standardized monograph for cannabis flowers

The European Pharmacopoeia has recently published a uniform monograph for cannabis flowers that sets clear standards for the quality and content of active ingredients. This monograph will form the basis for the quality assurance of medicinal cannabis in Europe. The new European Pharmacopoeia guidelines define clear parameters for the production and testing of cannabis flowers.
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Cannabinoid analysis scope expansion

Analysis spectrum of cannabinoid analysis extended! As you know, we always keep you informed about news, developments and updates at QSI so you as a valued are always up to date and kept in the loop! We always work with the goal of continous optimization and therefore we are pleased to inform you today that
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The synthesis lab at aromaLAB GmbH is now DIN EN ISO 9001 accredited

  aromaLAB GmbH is proud to announce that aromaLAB’s synthesis department achieved a successful certification of DIN EN ISO 9001 for the development and production of unlabelled and isotopically labelled standards. These aroma standards are used for research and analytical purposes by well-known international food companies, breweries and universities. The ISO 9001 certification was a
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Authenticity of soluble coffee („instant coffee“)

The authenticity of food is increasingly the focus of the food industry and third-party monitoring. The proof of an authentic food product is provided by a combination of different measures such as documentation along the supply chain, audits, risk analysis, avoidance strategies, but also by actual chemical analysis of products. For soluble coffee („instant coffee“),
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Labocor Analítica expands its ENAC scope in food and feed

Labocor Analítica achieves an important extension of its ENAC scope in food and feed, as a result of its commitment to the continuous improvement of all its analytical services. Labocor Analítica has achieved the extension of its ENAC scope in the following tests: Fat by gravimetry for Feed and its raw materials, Cereals and derivatives,
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New developments in HACCP by the EC

The European Commission has issued a new communiqué which aims to lay the foundations and provide tools to instil a Food Safety Culture in the EEA, which goes beyond the simple implementation of a HACCP-based system. With the entry into force of COMMISSION REGULATION (EU) 2021/382 of 3/03/21 amending the Annexes to Regulation (EC) No
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