Pharmaceutical Stability studies
In drug development the chemical, physical and microbiological properties of products or substances should be maintained. Decelerating factors e.g. API degradation are addressed via pharmaceutical stability testing. Pharmaceutical Stability studies are necessary at drug product Development, Reformulation of remarketed products, Modification of production methods, Manufacturing site swift and Product packaging modification.
QACS Labs provides pharmaceutical stability testing, storage stability services and custom solutions based on international standards. We test API’s, raw materials and final products in recommended environmental storage conditions such as Temperature, Humidity, Light and Duration-Long term/Accelerated.
Our GMP certified laboratory system allows for pharmaceutical stability studies for quality evaluation at specific time intervals and under controlled and monitored conditions. Pharmaceutical stability studies are supported by walk-in chambers, thermal stability chambers, humidity control climatic chambers and storage space.
- Real time
- 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