Stability tests for Phytopharmaceuticals

Do you require stability studies?

The PhytoLab Newsletter dated 25 April 2023 provided an overview of the services that we offer in the field of food supplements. Vitamins are outstandingly important value-adding ingredients in this and other product groups.

PhytoLab’s service for you

We support you with appropriate concepts throughout every phase of your project. Our experts in the fields of regulatory affairs and analysis are also at your disposal with their specialist knowledge.

Plans for testing and removal from storage are drawn up by our experienced team and tailored to your specific requirements. All arrangements agreed with you are recorded in a stability protocol.

The results of the stability tests are processed, evaluated and documented proficiently. We are also happy to make them available in module 3.2.S.7 or 3.2.P.8 (eCTD-compliant) format, enabling you to integrate the stability data into your dossiers directly. Furthermore, we can provide assistance with the conceptual design of in-use studies (stability after opening). The opening procedure agreed with you is then performed and documented reliably by the experienced members of the PhytoLab team.

Stability studies for each phase in the life cycle

PhytoLab’s climatic conditions

Our climatic chambers are subject to GMP-compliant monitoring and documentation requirements. Apart from having sufficient storage space at our disposal, we also have correspondingly large laboratory capacity in a GMP-certified and DAkkS-accredited laboratory environment for physical, chemical and microbiological tests.

Climate zone II:

25 ± 2°C/60 ± 5 % rF
30 ± 2°C/65 ± 5 % rF
(intermediate condition)
40 ± 2°C/75 ± 5 % rF
(accelerated condition)

Climate zone IVa:

30 ± 2°C/65 ± 5 % rF

Climate zone IVb:

30 ± 2°C/75 ± 5 % rF

Cold storage:

5°C ± 3°C

Freezer storage:

–20°C ± 5°C

We have more than 25 years of experience in designing and conducting stability studies on herbal medicinal products. We are also at your disposal for the performance of stability tests on herbal foodstuffs, food supplements or medical devices.

Analysis:

DR. KLAUS REIF
Phone +49 9163 88-337
klaus.reif@phytolab.de

Sales:

MARTIN MÜLLER
Phone +49 9163 88-5534
sales@phytolab.de