Pharmaceutical Stability studies
In drug development the chemical, physical and microbiological properties of products or substances should be maintained. Decelerating factors such as API degradation are addressed via Pharmaceutical Stability Testing. Pharmaceutical Stability studies are necessary to be conducted during drug development, reformulation of remarketed products, modification of production methods, manufacturing site swift and packaging alterations.
QACS Labs provide pharmaceutical stability testing, storage stability services and custom solutions based on international testing standards. We test API’s, raw materials and final products in recommended environmental storage conditions such as Temperature, Humidity and Light. Long-term and Accelerated stability studies are also provided.
Our GMP certified laboratory system allows for quality evaluation at specific time intervals and under controlled and monitored conditions. We conduct Pharmaceutical Stability Studies by using state-of-the-art walk-in chambers, thermal stability chambers, humidity control climatic chambers and storage space.
- Accelerated under ICH or custom climatic zones
- Freeze thaw cycle studies
- Thermal stability
- Light, Photostability ICH Q1B
- Packaging Compatibility
- ICH Storage stability services
- Organoleptic properties – Appearance, color, odor, texture
- Analytical services – Viscocity, color, odor/fragrance, pH, weight, active ingredients, Traces Impurities, UV filters, Heavy metals, assay of preservatives
- Microbiological properties – Microbial count & microbial enumeration
- Functionality & Aesthetics