Stability testing on a drug or active ingredient (API) in a laboratory
Your needs: carry out a stability study of your medicine or active ingredient (API) as part of an R&D project or quality control
Why carry out a stability test on a medicine or API?
The stability study of a medicine or active ingredient (API) is a crucial step during its development or approval.
The performance of a medicine or active ingredient (API) depends on many parameters that can change over time. This is why the aim of a stability study is to understand how the product or the active ingredient (API) will evolve under previously established conditions over a determined period of time, and to study its evolution (performance, chemical composition, etc.). ) as well as its compatibility under its conditions of use.
The support of an external laboratory like FILAB will allow you to ensure the conformity and stability of your medicine or active ingredients (API)
What is a stability test?
When a product is subjected to a laboratory stability test, its performance is analyzed, thus bringing together several properties:
The function in order to ensure its effectiveness over time,
The texture and appearance to guarantee consistent quality,
Adhesion, particularly for products covering surfaces.
Our solutions: support you in carrying out a stability study as part of an R&D project or for a quality control test
Why call FILAB for a stability study of a medicine or API?
The FILAB laboratory offers you stability study services on your medicine or active ingredients (API). Thanks to our analytical park of 2,100m², significant storage space and a highly qualified team made up of doctors and engineers, FILAB provides the following services in particular:
Stability study according to the ICH Q1A standard
Development and validation of method to study the stability of a product
Forced degradation study of active ingredient according to ICH Q1A
Analysis of the final chemical composition of the product according to environmental conditions (temperature, humidity level, exposure to light, etc.) by GC-MS, HPLC or IRTF
Study of container-content interactions
Analysis and identification of impurities (molecular characterizations, etc.)
Analysis of active ingredients
Analysis and dosage of degradation product
To support you in the best conditions, the FILAB laboratory is approved for Research Tax Credit (CIR).
Why perform stability tests?
Over time, these characteristics may change, resulting in alteration/degradation of the product. These modifications can result from formulation instability, which can be anticipated with the appropriate tools and expertise.
Stability tests and the support of an external laboratory will allow you to ensure the conformity and stability of your products before they are placed on the market, thanks to carrying out a stability study.
The alteration or degradation of a sample is a frequent phenomenon in chemistry and pharmaceuticals. It can be caused by different factors such as humidity, temperature, light or interactions with other substances.
When a product is altered or degraded, its physical and chemical properties are changed, which may change its effectiveness or appearance. It is therefore essential to determine the optimal storage, manufacturing and use conditions.
What is chemical alteration or degradation?
The alteration or degradation of a sample is a frequent phenomenon in chemistry and pharmaceuticals. It can be caused by different factors such as humidity, temperature, light or interactions with other substances.
When a product is altered or degraded, its physical and chemical properties are changed, which may change its effectiveness or appearance. It is therefore essential to determine the optimal storage, manufacturing and use conditions.
Our solutions: carry out stability tests to study the evolution and compatibility of your products in their conditions of use.
The stability study: a FILAB expertise
For chemical formulations, formulation stability is important. Stability testing is performed to determine the useful life of a formulation, as well as to understand the effects of various factors. By understanding the stability of a formulation, industries can maximize the quality and durability of their products, which can also lead to cost savings. Extensive studies are necessary to ensure the reliability of results and ensure that formulations comply with regulatory and safety standards.
The ICH standard for stability studies in the pharmaceutical industry
A stability study according to the ICH standard, or International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use, is essential to guarantee the quality and effectiveness of pharmaceutical products. This standard establishes strict rules for determining the shelf life of a medicine by taking into account storage and transport conditions, as well as possible environmental variations.
The results of these stability studies on medicines or active ingredients are used for the labeling and prescription of medicines and may be required by regulatory authorities for each production batch. Pharmaceutical companies therefore attach great importance to stability study according to ICH standard to meet regulatory requirements and provide safe and effective medicine to patients.
Q&A
To ensure the stability of a medicine, it is important to take into account several factors during production to storage:
- drug design
- choice of ingredients to ensure their compatibility and uniformity.
- store the medicine at specific temperatures and humidity conditions,
Stability tests must be carried out throughout the production process, from product development to distribution. This ensures that the medicine maintains its physical and chemical properties in accordance with regulations.
When it comes to testing the quality of a product, there are two commonly used types of tests: stability testing and degradation testing.
A stability test evaluates the stability of a product under normal conditions of storage and use to verify its long-term stability.
A degradation test measures a product's response to extreme environmental conditions such as heat, light and humidity (environmental stresses). This test can help simulate and predict how a product will behave under defined conditions.
