Our company is a company with extensive experience in API analysis method development and stability study. We are able to conduct stability studies on various types of biological and chemical APIs under various conditions. Please feel free to contact us if you have any needs.
Our Services
Stability of API refers to the ability of API to maintain its physical, chemical, biological, and microbiological properties. The purpose of stability studies is to investigate the change of the properties of API over time under the influence of temperature, humidity, light, and other conditions, so as to determine the storage and transportation conditions of the API, and determine the appropriate storage period or retest period.
At our company, our experienced team can design a series of experiments to study the stability characteristics of API, including factor testing, accelerated testing, and long-term testing. Here are the stability testing services we offer for biological and chemical APIs.
| APIs | Stability Studies | Description |
|---|
| Biological APIs | Real-time and accelerated stability testing | The results of real-time stability and accelerated stability testing can be used to estimate the shelf life. In real-time stability testing, the API is stored under recommended storage conditions and monitored until it no longer meets the product performance specifications. In accelerated stability testing, the API is stored under elevated stress conditions, such as high temperature and/or humidity. The known relationship between the acceleration factor and the degradation rate can be used to predict the degradation under recommended storage conditions. |
| Forced degradation studies | Forced degradation studies are used to improve degradation rates by subjecting substances to extreme storage conditions. However, due to the nonlinear nature of protein degradation kinetics, these studies have limited predictive value for the shelf life of biological APIs. Nevertheless, forced degradation studies provide information about API decomposition and degradation pathways, making them particularly useful in early-stage drug development. They can help improve formulations and assist in determining storage conditions to control API stability. |
| Long-term stability studies | To ensure the stability of biological APIs, we conduct long-term stability studies using the recommended storage conditions. Additionally, we perform shorter duration studies at higher temperatures to assess their stability during shipping and usage. |
| Chemical APIs | Influencing factor testing | The influence factor testing is to investigate the degradation of chemical APIs under corresponding conditions, such as high temperature, high humidity, light, acid, alkali, oxidation, etc., so as to study the sensitivity of APIs on light, humidity, heat, acid, alkali, oxidation, as well as potential degradation pathways and degradation products that may be produced. It also provides reference information for the selection of packaging materials. |
| Accelerated testing | Accelerated testing and intermediate condition testing are mainly used to evaluate the impact of short-term deviations from the storage conditions stated on the label on the quality of the API. They also provide basis and supportive information for the setting of long-term testing conditions and the design of formulation processes. |
| Long-term testing | The long-term test is to investigate the stability of the API under the proposed storage conditions, and provide data support for confirming the packaging, storage conditions and expiration date (retest period). |
Our Techniques
| 1D and 2D SDS-PAGE | Western blot |
| Isoelectric focusing | Capillary electrophoresis including cIEF ,CE-SDS and CZE |
| Reverse-phase HPLC and mass spectroscopy | NMR |
| Stability-indicating chromatography | Spectrophotometric analysis (e.g., UV-Vis, fluorescence and circular dichroism) |
| ELISA | FTIR |
| UPLC (UV, LIF, fluorescence, refractive index, light scattering, electrochemical) | GC (FID, NPD, TCD, ECD) |
| Isothermal thermogravimetric analysis | Differential scanning calorimetry |
| LC-MS, GC-MS, GC/LC-MS-MS | Others |
Delivery
| Physical properties of APIs | Chemical properties of APIs |
| Gas chromatography | Other experimental data |
Please kindly note that our services are for research use only.
