Stability testing of narcotics

Our laboratories are equipped with experienced and professional teams and the latest analytical equipment.

We take care of the entire process of storing, performing and documenting your stability studies.

Storage of active ingredients and drug samples for ongoing stability studies as well as stress testing of BtM products according to ICH guidelines.
Cannabis stability studies
Stability is one of the most important quality characteristics of a drug product. We offer storage of test samples to monitor the quality and durability of your active ingredients, intermediates and finished products. We always follow the temperature regulations of the ICH guidelines under the conditions of the German Narcotics Act (BtMG) in the vault area.

The performance of ongoing stability studies has been mandatory since the amendment to Chapter 6 of the EU GMP Guidelines of June 01, 2006: One batch of each pharmaceutical product must be stored per year in each marketed primary packaging material under controlled conditions (ICH or CPMP/QWP/122/02) and analyzed at specified times.

Storage is carried out in modern climatic chambers in the climatic ranges 25 °C ± 2 °C / 60% ± 5% RH and/or under stress conditions at 40 °C ± 2 °C / 75% ± 5% RH.

It goes without saying that the climatic conditions are continuously documented by EDP throughout the entire storage period.

Cannabis stability studies

For medicinal cannabis flowers, we offer stability testing at 25 °C / 65% RH or 30 °C / 75% RH, among others. In addition, you can of course also produce cannabis extracts with us, fill them and integrate them into a stability program at e.g. 2 - 8 °C.

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Do you have questions or need more information? PS Pharma Service GmbH stands for personal support by our experts and the best customer service. Get in touch - we will be happy to advise you.
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Semdor Pharma Group
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