Purity isn’t the only factor in determining an API’s quality. The long-term stability of the pharma product’s purity is what truly matters. The stability of pharma products, such as APIs, indicates that they will not degrade during storage and transportation. That’s where API stability testing becomes essential for pharma manufacturers. We will learn about stability testing and why it is important in the production of pharmaceutical products.
What Is API Stability Testing?
API stability testing is a set of tests that assess the API’s quality over a defined period and under various conditions. The test examines how the API’s chemical, physical, and microbiological properties change as temperature, humidity, light, and oxygen levels vary.
The objective is to determine the shelf life, storage conditions, degradation rate, and expiry period of the APIs. It helps pharmaceutical firms make safe products that comply with the rules.
The pharma testing protocols for stability must include:
- General Product Information
- Specifications And Test Methodology
- Details Of The Study Plan
- Stability Data And Information
- Data Analysis
What Are The Parameters For Stability Testing?
Stability testing examines the impact of diverse environmental conditions on the quality assurance of APIs. The following are a few parameters observed in the API stability testing:
- Potency: Determine how the potency is compromised over time and in different conditions
- Degradation & impurities: Identify the change in impurity profile
- Appearance: Physical change in the colour, crystals, texture, and more
- pH profile: Changes in the pH profile over time
- Moisture content: Change in the moisture of the API
- Polymorphic Stability: Change in solid-state APIs
Types Of Stability Testing For Pharmaceutical Products
API stability testing isn’t a single process; it’s a set of tests that assess changes across different environmental conditions. The following are the three critical tests for quality assurance of APIs.
Long-Term Stability Test
Long-term stability studies focus on the API shelf life and the impact of storage conditions over extended periods. The APIs are tested in a room with real-world temperature conditions to identify any changes. The time period can range from 1 to 3 years.
The ideal temperature range used in this test is 30°C ± 2°C / 65% RH ± 5% RH. The test analyzes the API’s quality every three months for the first year, twice in the second year, and annually thereafter. This test helps you determine the shelf life and ideal storage conditions.
Accelerated Stability Test
In the Accelerated Stability Test, extreme temperatures and humidity are used to accelerate degradation. Thus, the pharma company can check the stability of the APIs in a relatively shorter time.
It is used to identify degradation trends early, reduce development and testing time, and evaluate the suitability of packing and storage solutions.
Stress Stability Test
In the Stress Stability Test, APIs are exposed to extreme conditions, such as high temperatures, humidity, oxidation, and light, to induce degradation. The goal of this test is to identify the by-products developed after degradation. That’s why it is also known as Forced Degeneration Testing.
The test results are critical for API development and regulatory compliance.
Why Is Stability Testing Important In Pharmaceutical Development?
The following are a few reasons why API stability testing matters in the pharma industry.
Quality Assurance
For APIs to be of good quality, they must pass stability tests. It helps the manufacturer maintain consistent quality, identify potential risks early, and evaluate the processes for manufacturing and packaging. Quality compliance makes it easier to obtain government approvals and reduces the risk of product recalls.
Ensure Safety And Efficacy
Stability tests help you identify potential adverse effects and toxic degradation by-products early. Thus, pharma companies can develop safe formulations that achieve long-term therapeutic effects and enhance patient safety.
API Shelf Life
Stability testing helps you identify the ideal storage option for better shelf life. By identifying the optimal shelf life and retest period, you can reduce waste, manage inventory, and deliver reliable pharmaceutical products to the market.
Better storage
By exposing the APIs to extreme environmental conditions, you can identify which storage option reduces degradation and improves shelf life. It is vital for transportation and the API’s shelf life.
Regulatory Approval
API regulatory authorities require comprehensive stability data as part of DMFs and API dossiers. Compliance with ICH stability guidelines is essential for global market approval.
Chemox Pharma is one of the most reliable API manufacturers in India, known for its strict adherence to quality standards. Our WHO-GMP approved production facility has API stability testing equipment and processes to ensure that each API is safe for further processing. Contact us for any queries.
Conclusion
In the pharma industry, API stability testing is one of the most critical processes. It helps in quality assurance of APIs across different environmental conditions. Different testing methods are used to determine shelf life, ideal storage conditions, and the by-products of degeneration. This is essential for developing a stable and safe API for medicine and drug development. Explore APIs developed in Chemox Pharma’s WHO-GMP certified facility. Contact us to know more.
FAQ
What Is Stability Testing In The Pharma Industry?
Stability testing is one of the most critical processes in the pharma industry. It helps us determine how any drugs or APIs will maintain quality, safety, and efficacy over time under defined environmental conditions. It helps us identify the shelf life, storage conditions, and by-products of pharma product degradation under different conditions. Stability testing ensures the consistent quality and safety of patients.
What Are The Factors Affecting The Stability Testing?
The results of stability tests depend on factors such as temperature and humidity, light exposure, oxygen levels, packaging conditions, and the chemical formulation of the APIs. To ensure API quality remains high throughout its shelf life, manufacturers need to know these things so they can develop the right storage and packaging solutions.
What Are The ICH Guidelines For Stability Testing?
The ICH guidelines establish the necessary testing conditions, required study durations, specific climatic conditions, and data requirements for conducting long-term and accelerated stability tests. The guidelines develop consistent standards to determine the shelf life of APIs and medicines for regulatory compliance.
Why Is Stability Testing Important For APIs?
The following are a few reasons why Stability Testing is important:
- Formulation stability for an extended period under different environments
- Determine ideal shelf life and storage solution
- Identify the by-products of degeneration during shelf life
- Get regulatory approval for the international market
