AZ Biopharm becomes FDA-inspected laboratory
The Analytische Zentrum Biopharm Berlin is pleased to announce that we passed the FDA inspection in September this year without any findings. This success reflects our unwavering commitment to the highest quality standards and our continuous work to ensure the integrity of your products and our services. We thank our customers for their continued trust and endeavour to further strengthen our partnerships. For detailed information about the audit, please do not hesitate to contact us.
AZ Biopharm will attend Bionnale 2023 conference
AZ Biopharm will attend Bionnale 2023 conference – a networking event for start-ups, pharma companies, entrepreneurs and CROs.
Renewed GLP certification
We are pleased to announce that AZB has successfully renewed its GLP certification. This achievement confirms our commitment to high quality and safety in conducting analyses in this field, and provides our customers with the assurance that they are working with a trustworthy and reliable partner.
AZ Biopharm has expanded its analytical toolbox by a recent acquired GC-MSMS from Shimadzu type TQ8060 NX.
With this we can now conduct much more sensitive and selective trace analysis of drug products, APIs, raw materials and phyto-pharmaceuticals. In particular, for the analysis of contaminants as pesticides in cannabis, CBD and dronabinol, GC-MSMS provides the needed sensitivity and selectivity to fulfil the requirements according PhEur.
AZ Biopharm published a guest article in the FAZ on the future of the cannabis business in Germany after the release by the German government
“The coalition agreement of the SPD, Green party and FDP provides for the controlled supply of cannabis to adults for recreational purposes and a permit for cultivation for commercial purposes. With this newly created availability comes the need to systematically analyze and regulate cannabis products to protect consumers from pesticides, biological contaminants and heavy metals. As a certified laboratory, the Berlin-based testing laboratory AZ Biopharm will play a central role in the testing of large batches of cannabis in the future. In this article, the managing directors Dr. Martin Reinsch and Dr. Berthold Lausecker give an overview of the current situation of legalization, the need for exact analysis and possibilities for testing cannabis products.”
Ultra-sensitive Nitroglycerin LC-MSMS assay established for support of BE studies
Nitroglycerin, a vasodilator, is used to treat people who have coronary artery disease. It works by relaxing the blood vessels by releasing nitric oxide so the heart does not need to work as hard and therefore does not need as much oxygen. Nitroglycerin is metabolized to 1,2- and 1,3- dinitro-glycerin, which have still pharmacologic activity. The metabolites have the same mass and the same fragment, and so must be chromatographically separated.
Our contribution to fight Covid-19
As we all learned from the daily communication in the TV and newsletters “boostern” is the best way to prevent infection with SARS-Cov-2.
AZ-Biopharm is present at the International Cannabis Business Conference (ICBC) B2B.
This conference will take place on August 26-27, 2021 at the Vienna House Andel’s Berlin,
Landsberger Allee 106, 10369 Berlin (https://internationalcbc.com/berlin/).
Nitroso-amine screening method established at AZ-Biopharm for 12 N-nitrosamines.
At AZ-Biopharm we established, after the development and validation of a GC-MS and an even more sensitive UHPLC-MSMS method for the determination of N-nitroso-dimethylamine (NDMA) in drugs and in APIs, a screening method for 12 nitrosamines.
AZ Biopharm has started vaccination of personnel against Covid-19
AZ-Biopharm has early on implemented measures to protect our personnel from Covid-19 infections.
