Stability Testing

Stability Testing

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.

Fig.1 Stability Testing Services

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.

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.

Fig.2 Vaccine Stability Testing

  • 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.