Quality Control and Stability Studies

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.

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.

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.

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