Stability
Cornerstones are necessary for a successful structure: stability studies for development and essentially, approval of active pharmaceutical substances. Only so, can quality of medicinal products be assured. Based on stability studies from DISCH, you can determine the life span of your product yourself, and so guarantee the end-consumer that the active agent fulfills the specifications you defined. According to your product requirements, stability tests can be chosen from our wide range.
International stability studies according to ICH
The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) aims at harmonising judgement criteria for medicine destined for people worldwide. DISCH offers 2 types of studies, which are evaluated by ICH guidelines. For both, random tests and storage qualities must fulfill the ICH guidelines:
- long term stability studies: DISCH tests the product for at least 12 months.
- Follow-up stability studies: DISCH tests the certainty of the product; for example, the active substance is monitored during its time in storage.
Product specific stability studies
Depending on which requirements your product must fulfill, you can choose from either a stability-stress study or a tailor-made stability study.
- Stability stress study: DISCH tests storage qualities of the product and its active ingredients.
- tailor-made stability study: DISCH defines parameters to use for tests; after the study a detailed report is issued.
Your product from A to Z
We can offer you the complete service – from concept to product launch. Your product is:
- manufactured to specific standards (food or GMP)
- certified by Swissmedic
Quality assurance
Additionally we carry out quality tests, stability studies and develop testing methods to ensure quality remains constant.
What can we do for you?
Curious about stability studies at DISCH? We can gladly advise further on tel. +41 62 887 20 00 or info@disch.ch.
