Pharmaceutical stability testing is a process that involves evaluating the chemical and physical stability of a pharmaceutical product under various environmental conditions, such as temperature, humidity, and light exposure. This testing helps pharmaceutical companies determine the appropriate storage conditions, expiration date, and packaging for their products. Additionally, it ensures that medications remain safe and effective throughout their shelf life, which is critical for patient safety and treatment outcomes, and helps pharmaceutical companies comply with regulatory requirements and guidelines set forth by organizations such as the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH). At our company, we have established a comprehensive pharmaceutical stability testing platform and offer a comprehensive range of services.
Our Pharmaceutical Stability Testing Platform
Our stability testing platform specializes in professionally ICH stability studies for a variety of dosage forms, APIs, and product types, including OINDP, biopharmaceuticals, vaccines, etc. And we can provide stability testing services in every step of the life cycle of these pharmaceutical products, from early development to late stage. The stability testing services at our platform include:
1Accelerated Stability Testing
Accelerated stability testing involves subjecting the drug product to elevated temperatures and humidity levels to simulate long-term storage conditions in a short period of time.
2Long-Term Stability Testing
Long-term stability testing involves storing the drug product under normal storage conditions for an extended period of time to monitor any changes in its physical and chemical properties.
3Intermediate Stability Testing
Intermediate stability testing refers to the testing of a product at various time points throughout its shelf life to assess its stability under different conditions. This type of testing is typically conducted after accelerated stability testing and before the final stability testing.
4Photostability Testing
Photostability testing assesses the drug product's sensitivity to light and helps determine whether it needs special packaging to protect it from light exposure.
5Forced Degradation Studies
Forced degradation studies involve subjecting the drug product to extreme conditions such as heat, light, and acidic or basic environments to accelerate degradation processes and identify potential degradation pathways.
6Real Time Stability Testing
Real time stability testing involves subjecting the product to specific conditions, such as temperature and humidity, to simulate different environmental factors that could impact its stability.
7And More
We also provide in use stability testing, follow-up stability trials, formulation stability testing, cyclic temperature stress testing, etc.
Available ICH Stability Conditions
Our pharmaceutical stability testing platform offers a professional of ICH stability storage facilities. With climatic walk-in chambers, cabinets, and refrigerated and freezer storage, we cover all ICH stability conditions. Moreover, it is equipped with fully controlled and monitored chambers, backed up for added security, and our 24-hour alarm systems and on-call teams ensure quick responses to any storage condition excursions. Here are the ICH stability conditions that we can offer:
- 21°C/ 45% RH
- 25°C / 60% RH
- 30°C / 35% RH
- 30°C / 75% RH
- 40°C / NMT 25% RH
- Storage at 2-8°C
- ICH photostability testing conditions (ICH Q1B Photostability Options 1 & 2)
- …
- 25°C / 40% RH
- 30°C / 25% RH
- 30°C / 65% RH
- 40°C / 75% RH
- Cabinets at 50 °C, 57 °C, 60 °C
- Ultra-low temperature storage at -20°C, -40°C, -80°C
- Freeze/thaw temperature cycling tests conditions
- Specialized conditions
Pharmaceutical stability testing is a critical process in the drug development and manufacturing process that helps ensure the safety and efficacy of medications. By partnering with a reputable pharmaceutical stability testing service, companies can mitigate potential risks and ensure the quality of their drug products for the benefit of patients worldwide. Contact us today to learn more about how our platform and services can benefit your projects.
Related Services
It should be noted that our service is only used for research, not for clinical use.
