Stability testing of pharmaceutical products involves intricate procedures requiring significant time, cost, and expertise to ensure quality, efficacy, and safety in drug formulations. This process, also known as GMP stability testing, is essential at every stage of drug development to establish shelf life and storage conditions in compliance with regulatory standards.
Stability testing plays a crucial role in drug development, ensuring the identity, potency, and purity of both Active Pharmaceutical Ingredients (API) and formulated products. By evaluating these products under varying environmental conditions—such as light, temperature, and humidity—scientists gain real-time insights into their stability and performance under different storage factors.
Our stability testing processes play a vital role in product and drug development by identifying critical stability factors essential for product validation. This includes assessing degradation factors and the time required for degradation, along with routine evaluations of parameters such as temperature, moisture content, residues, and microbial presence.
Throughout the stability testing period, we conduct periodic analyses of identity, physical appearance, disintegration, dissolution, loss on drying, related substances, assay, residual solvents, and microbial content to ensure accurate stability assessments. Backed by a skilled team and advanced infrastructure, we deliver reliable stability studies under real-time conditions throughout the product lifecycle.
Forced degradation studies during stability testing include the following parameters:
ShreeHari Testing Lab is equipped with advanced stability walk-in chambers, capable of maintaining various temperature and humidity settings with validated monitoring systems. Additionally, we offer photo stability testing using our state-of-the-art photostability chamber.
Our cutting-edge stability testing facilities, combined with a team of skilled analysts and scientists, provide GMP-compliant stability testing services for pharmaceutical companies.
| Temperature | Humidity |
|---|---|
| 30°C ± 2°C | 65% ± 5% |
| 30°C ± 2°C | 75% ± 5% |
| 40°C ± 2°C | 75% ± 5% |
| 25°C ± 2°C | 60% ± 5% |
| 2°C - 8°C | No Humidity |
The features offered by our stability testing labs include:
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