Stability Testing Customised Contract And Studies Investigations For Each Phase Of Growth
The Objective of stability testing is to discover how a pharmaceutical product or an active ingredient varies over a specified period of time under specific conditions temperature, air humidity, light. The shelf-life and the suggested storage conditions for an active ingredient or medication 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 period, you may require a coordinated array of services over a broad array of climatic conditions in addition to physical, chemical and microbiological tests.As a GMP-accredited and FDA-registered contract lab in Switzerland, we will have the ideal solution for you. Whether it is storage, detailed support beginning with the preparation of the analysis, method development and validation or continuing equilibrium studies, you can benefit from our experience from 15 years of stability studies.
Planning stability studies
Stability studies are a fundamental element in the Development and acceptance of new pharmaceutical active ingredients and medication. The Stability Testing ensure that your product or active ingredient fulfils the specifications of the specified storage requirements over the whole shelf life. The choice of the right parameters to be analysed during the study in addition to accurate and reliable project planning would be the foundation for meaningful and persuasive data. The suitable approaches and correct storage conditions appropriate to the climate of the target market both have to be set and sampling schedules have to be developed. The ICH guidelines Q1A-Q1F function here as a reference.
Stress tests with active ingredients
The first information about the stability profile of the active ingredient is obtained here. The effect of temperature, humidity, light, pH-value and oxidising agents on the active ingredient are tested here forced degradation study. The gathered findings are then summarised as an active ingredient equilibrium profile and used as the basis for galenic development and the development and validation of the analytical techniques.In this measure, the stability of Many Different pre-formulations depending on the storage requirements is tested. It is necessary to assess the influence and the stability of the excipients used and to ascertain which excipients are harmonious. The major goal here is to ascertain a definitive formula for the new medication.