Stability Testing

Stability Testing

Customised studies and contract analyses for each phase of development

The goal of stability testing is to discover how a pharmaceutical product or an active ingredient changes over a defined period of time under certain conditions (temperature, air humidity, light). The shelf-life and the recommended storage conditions for an active ingredient or medicine among other information can be derived from the results.

Every stability study is treated as a customised order. Depending upon the product and the project phase, you will require a coordinated range of services over a wide range of climatic conditions as well as physical, chemical and microbiological tests. 

Are you looking just for storage space or for complete project implementation? As a GMP-accredited and FDA-registered contract laboratory in Switzerland, we will have the best solution for you. Whether it is storage, comprehensive support beginning with the planning of the study, method development and validation or on-going stability studies, you can take advantage of our experience from 15 years of stability studies.

 

We will be happy to advise you.

Read on here for more information or contact us.


PLANNING STABILITY STUDIES

Stability chambers with a variety of climatic conditions
Stability chambers with a variety of climatic conditions

Stability studies are a central component in the development and approval of new pharmaceutical active ingredients and drugs. The tests guarantee that your product or active ingredient fulfils the specifications of the given storage conditions over the entire shelf life. The choice of the correct parameters to be analysed during the study as well as exact and reliable project planning are the basis for meaningful and convincing data. The suitable methods and correct storage conditions appropriate to the climate of the target market both need to be determined and sampling schedules must be developed. The ICH guidelines Q1A-Q1F serve here as a reference.

Stress tests with active ingredients

The first information about the stability profile of the active ingredient is obtained here. The influence of temperature, humidity, light, pH-value and oxidising agents on the active ingredient are tested here (forced degradation study). The accumulated findings are then summarised as an active ingredient stability profile and used as the basis for galenic development and the development and validation of the analytical methods.

Stability test - pre-formulation

In this step, the stability of a variety of pre-formulations depending on the storage conditions is tested. It is important to evaluate the influence and the stability of the excipients used and to determine which excipients are compatible. The main goal here is to determine a definitive formulation for the new drug.

Stress tests with scale-up batches

This stability test on the selected formulation takes between 3 and 6 months. The goals are: A prediction of the EXP date of the final dosage form, a provisional determination of the specifications and release of the samples for phase I to III clinical trials and observation of stability during the clinical phases.

Stress and long-term test with registration batches

Secure climate chamber
Secure climate chamber

Accelerated testing and long-term testing of three representative production batches of both the active ingredient and the finished product for registration are carried out. Both the formulation and the packaging must correspond to the final commercial product.

The stability study lasts a minimum of 12 months and the sampling and storage conditions comply with the recommendations of the ICH guidelines. In this step, predictions of the re-test period for the active ingredient and the EXP date for the final product are determined.

Follow-up stability tests

Follow-up stability tests are carried out according to the ICH guidelines for three representative production batches of the active ingredient and the product. The stability test can last up to 60 months. Long-term studies are frequently continued from the previous step.

The goals are: Fixing the specifications after approval, confirmation and extension of the re-test period of the active ingredient, and fixing the EXP date of the final product.

Do you require additional information?

Please read the unabridged version in our technical article (see the right-hand column) or ask for advice from our customer services.


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Michael Trösch Graduate Chemist HTL

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