Stability and Drug Release Testing
At Cubic Analytical Solution, we offer reliable Stability and Drug Release Testing services to ensure that your pharmaceutical products maintain their quality, efficacy, and safety throughout their shelf life. These critical tests are essential for meeting regulatory requirements and ensuring patient safety by evaluating how your product performs over time and under various conditions.
(All zone Stability Testing as per ICH Guidelines)
- Long term
- Intermediate
- Accelerated
- Photostability
- Determination of Shelf Life
Key Insights into Stability and Drug Release Testing
Stability Testing
Our stability testing services assess longevity and shelf-life of your products under various conditions, including temperature, humidity, and light. Following ICH guidelines, we simulate real-world storage and provide data on degradation of active ingredients, changes, and expiration, ensuring your product remains stable and effective.
Drug Release Testing
Dissolution testing is vital for evaluating the rate and extent of drug release from dosage forms like tablets, capsules, and extended-release products. Using advanced dissolution apparatus and techniques in accordance with pharmacopeial standards (USP, BP, and Ph. Eur.), we provide precise measurements of drug release profiles.
Importance of Stability and Drug Release Testing
Stability and drug release testing are essential for ensuring quality of products. Stability testing helps establish storage conditions, packaging, and shelf life, while drug release testing ensures medications perform as expected, releasing active ingredients at the right rate for outcomes.
Customizable Solutions
We offer customizable stability and drug release testing programs tailored to your needs. Whether you need routine stability testing for batch release or long-term studies for development, our services align with your regulatory and business objectives. Our experts work with various dosage forms, including tablets, injectables, and transdermal systems.
Regulatory Compliance Support
Our stability and drug release testing services adhere to ICH, FDA, EMA, and other international regulatory guidelines. We assist you in compiling the necessary documentation for regulatory submissions, ensuring that your product meets all requirements for market approval and quality control.
Expert Consultation and Support
In addition to testing, we offer consultation to help interpret results and optimize formulations. Our knowledgeable team assists in understanding how stability factors and drug release profiles affect performance. We provide training to enhance team’s understanding of critical processes.
Why Choose Us?
At Cubicana, we combine industry expertise with cutting-edge technology to deliver precise and reliable stability and drug release testing. Our commitment to quality and client satisfaction ensures that you receive comprehensive, tailored services that meet your specific needs and regulatory requirements.