Ensuring Product Stability with Precision
Comprehensive Stability Studies and Analysis
Our stability studies are designed to evaluate the quality and durability of pharmaceutical products under various environmental conditions. We provide both GMP and non-GMP services to ensure your products remain effective and safe throughout their shelf life.
Stability Studies: GMP and non-GMP
Stability Studies: GMP and non-GMP
Our stability studies encompass both Good Manufacturing Practice (GMP)-compliant and non-GMP options, ensuring flexibility depending on the stage of product development. GMP stability studies are critical for regulatory submissions, while non-GMP studies can support early-phase development or exploratory work.Stability Chambers Set to ICH Conditions
Utilizing advanced stability chambers, we conduct studies under International Council for Harmonisation (ICH) conditions. These chambers maintain controlled environments with precise temperature and humidity settings, simulating real-world storage scenarios. Typical conditions include:- Long-term stability: 25°C/60% RH for 12 months or longer
- Accelerated stability: 40°C/75% RH for shorter timeframes (typically 6 months)
- Intermediate conditions: 30°C/65% RH as necessary
Color-Coding for Accuracy
To enhance accuracy and organization, we employ a systematic color-coding system throughout the stability study process. This method aids in the clear identification of study phases, product samples, and storage conditions, minimizing the risk of errors and improving data integrity.ICH Guideline Test Intervals
Our stability studies adhere to the recommended testing intervals outlined by ICH guidelines. Testing is typically conducted at specified time points (0, 3, 6, 9, 12, and 24 months), allowing us to monitor and evaluate product performance and quality over time.
Stability Study Quality Attributes
We rigorously assess critical quality attributes (CQAs) to determine the stability of your product. This includes:
- Potency: Measuring the active ingredient concentration to ensure it remains within specified limits.
- Purity: Analyzing impurities and degradation products that could affect product safety and efficacy.
- Dissolution: Evaluating the rate and extent of drug release from its formulation.
- Appearance: Monitoring physical characteristics such as color, clarity, and any phase separation.
- pH and other physicochemical parameters: Ensuring consistency in formulation characteristics that may impact stability.
Stability Study Analysis & Reporting
After completing the stability studies, our expert team conducts in-depth analyses of the collected data. We provide comprehensive reports detailing:- Stability profiles: Trends observed over time regarding potency, purity, and other attributes.
- Recommendations: Insights on formulation adjustments, packaging modifications, or shelf-life extensions.
- Regulatory compliance: Documentation that meets the requirements for regulatory submissions and quality assurance protocols.
