Application:

The International Conference on Harmonization, comprising councils representing the pharmaceutical industry, as well as scientists and authorities, defines the demands on functionality, performance and documentation for stability tests in the pharmaceutical industry in its ICH guidelines. Europe, Japan and the USA agreed to common stability tests.

The objective of these tests is to gather information in order to make recommendations regarding the stability of substances or pharmaceuticals. The ultimate goal is to verify the stability of chemical, microbiological and physical characteristics after exposure to temperature and humidity over a defined period.

 

Only tested pharmaceuticals get the required approval …

As quality criteria of the stability tests the stability of chemical, microbiological and physical characteristics of pharmaceutical substances are tested after exposure to the influence of temperature and humidity over a defined period to determine the shelf-life time. To that end, the following climate conditions were established for long-term testing, accelerated testing and testing at intermediate conditions according to the ICH* Guideline Q1A.

temperature stability test chambers

General case

Long Term 25 °C ±2 °C/60 % r.h. ±5 % r.h. or 30 °C ±2 °C/65 % r.h. ±5 % r.h.

Accelerated 40 °C ±2 °C/75 % r.h. ±5 % r.h.

Intermediate 30 °C ±2 °C/65 % r.h. ±5 % r.h.

 

Semi permeable containers

Long Term 25 °C ±2 °C/40 % r.h. ±5 % r.h. or 30 °C ±2 °C/35 % r.h. ±5 % r.h.

Accelerated 40 °C ±2 °C/ not more than 25 % r.h.

Intermediate 30 °C ±2 °C/65 % r.h. ±5 % r.h.

 

Drug substances intended for storage in a refrigerator

Long Term 5 °C ±3 °C

Accelerated 25 °C ±2 °C/60 % r.h. ±5 % r.h.

 

Drug substances intended for storage in a freezer

Long term -20 °C ±5 °C

During the entire test the deviation in temperature is stipulated at ±2 °C and the deviation in relative humidity is stipulated at ±5 % r.h.

In the ICH* Guideline Q1B the methods for performing photostability tests are established with an irradiation dose of 1.2 million lxh and an integrated UV part of 200 Wh/m².

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Climate test chambers with optimized storage areas for reliable stability testing of pharmaceuticals …

According to the ICH* Guideline Q1A stability tests have to be performed under defined climatic conditions in order to furnish evidence of the stability of active substances and pharmaceuticals. To that end, we have developed a specific range of test cabinets and test chambers together with the pharmaceutical industry. Stability tests are an important step in the course of the development of new drugs and pharmaceutical substances. They are an indispensable element of the process for granting of licenses for the product by the authorities, but they are just as important for safeguarding the quality of the product in the framework of quality assurance. Together with committees from the pharmaceutical industry experts from the authorities granting the required licenses, such as e.g. the FDA, have developed the ICH* Guidelines for the harmonisation of stability tests which define standardized storage, the evaluation of the batches as well as the time sequence of the required analytic tests. The guidelines are valid in the EU, Japan and the USA. For other regions climate zones have also been established; however, depending on the respective country, the execution of such tests may not be mandatory.