Introduction to Quality Control and Stability Studies:
- Quality control (QC) and Stability Studies ensure that aerosol products remain safe, effective, and consistent throughout their shelf life.
- Quality Control and Stability Studie verify product identity, purity, and potency.
Quality Control Measures:
- Raw Material Testing: Verification of the identity, purity, and potency of APIs, propellants, and excipients.
- In-Process Controls: Monitoring of fill volume, weight, and pressure during manufacturing.
- Final Product Testing: Includes assays for dose uniformity, particle size, spray pattern, and valve performance.
- Microbial Testing: Ensuring that the product remains within acceptable microbiological limits.
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Stability Studies:
Objective:
- To evaluate how the product withstands various environmental conditions (temperature, humidity, light) over time.
Protocols:
- Real-Time Stability: Products are stored under recommended conditions and tested at regular intervals.
- Accelerated Stability Testing: Elevated temperatures and humidity levels are used to predict long-term stability in a shortened timeframe.
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Parameters Monitored:
- Physical Stability: Changes in the aerosol plume, phase separation in suspensions, or changes in viscosity.
- Chemical Stability: Degradation of the API or other formulation components, changes in pH, and formation of impurities.
- Propellant Stability: Ensuring that propellant pressure remains consistent and that no interactions compromise the container integrity.
Thank you for reading from Firsthope's notes, don't forget to check YouTube videos!
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