Protheragen-ING Lab offers comprehensive ICH pharmaceutical stability testing services to ensure the quality, efficacy, and safety of your medicines. Our team of highly qualified scientists has extensive experience in drug stability testing across a wide range of drug formulations and therapeutic areas. We have an in-depth understanding of regulatory requirements and industry best practices to deliver accurate and reliable results.
As your experienced stability study service partner, we offer efficient study management, flexible storage conditions, and testing capabilities to meet your trial requirements for real-time stability, long-term, intermediate, and accelerated stability studies, forced degradation, photostability, and other studies.
Why pharmaceutical stability testing?
ICH (International Conference on Harmonization) Pharmaceutical stability testing is an important part of pharmaceutical development, especially in support of IND/NDA submission activities. Our pharmaceutical stability testing evaluates the stability of active pharmaceutical ingredients (APIs) and drugs under the influence of a variety of environmental factors such as temperature, humidity, light, and pH. Data from these studies can help determine identify degradation pathways, establish storage conditions, retest intervals, and shelf life.
Available ICH stability conditions
We offer a wide range of drug stability storage stability conditions [controlled temperature and relative humidity (r.h.)] according to ICH guidelines, including but not limited to the following:
- 21℃/45% r.h.
- 25℃/40% r.h.
- 25℃/60% r.h.
- 30℃/25% r.h.
- 30℃/35% r.h.
- 30℃/65% r.h.
- 30℃/75% r.h.
- 40℃/75% r.h.
- 40℃/NMT 25% r.h.
- Store at 2-8℃.
- Ultra-low temperature storage -20℃, -40℃, -80℃.
- ICH Q1B Photostability Options 1 and 2.
- More special conditions.
Find out more about each of our services
We can provide you with the following pharmaceutical stability testing programs, including but not limited to:
Real-time stability test
Evaluate the chemical, physical, and microbiological properties of test samples over a defined period.
The test simulates actual storage conditions to evaluate the stability of a drug formulation in a real environment.
Accelerated stability test
Evaluate the stability of test samples faster by subjecting the product to harsher conditions, such as elevated temperature and humidity.
The test provides valuable insight into potential degradation pathways and can reliably predict product shelf life under normal storage conditions.
Forced degradation test
Test samples are subjected to extreme conditions such as heat, light, oxidation, or pH changes.
This testing helps identify and understand degradation pathways, impurity formation, and potential interactions, providing valuable insights for formulation optimization and stability enhancement.
Light stability test
Evaluates the susceptibility of test samples to degradation due to exposure to various light sources, including natural and artificial light.
This test is particularly important for photosensitive formulations, such as photo-unstable drugs, to ensure product integrity throughout the shelf life.
Long-term stability test
The stability and degradation of test samples over an extended period are regularly evaluated.
This test provides valuable data on product shelf life, storage conditions, and recommended handling methods to ensure product quality and regulatory compliance.
Stability studies tailored to your drug products
Backed by years of expertise with comparable pharmaceutical products, Protheragen-ING Lab delivers stability studies customized to your unique API, stage of development, packaging materials, and anticipated storage conditions. We can provide a tailored stability testing solution to satisfy your unique needs, whether you're creating a novel medication formulation or need to assess the shelf life of an already marketed product.
- Therapeutic protein.
- Vaccine.
- Gene therapy products.
- Viral vector.
- Nucleic acid.
- Antibodies or related products.
- Peptide.
- Cell therapy products.
- Drug delivery system.
- Small molecule.
Contact us today to learn more about our pharmaceutical stability testing services and how we can assist you in navigating the complex landscape of drug development.