Drug Stability

• Stability - the ability of a particular formulation in a specific container or closure system to remain with in its physical, chemical, microbiological, therapeutic and toxicological specifications
• Shelf Life - period when the formulation is expected to remain “fit for use” under ordinary conditions of handling and storage in the environment such as warehouse, home, hospital and pharmacy shelf
• Expiration Date - the direct application and interpretation of knowledge gained from stability testing
• Chemical Stability - causes chemical deterioration incompatibilities
• Short Term or Accelerated Stability Studies - involves the use of Exaggerated conditions of temperature, light, moisture, pH and humidity to test the stability of drug formulations
• Long Term or Real Time Stability Studies - under the usual/normal conditions of the environment, transport and storage expected during product distribution
• Stress Tests - involves the use of elevated temperatures in 10 degrees increments higher than those in ASS; performed until the total physical and chemical degradation of the product is reached; duration of 6-12 months
• Storage Temperatures

  A) Cold

  B) Refrigerator

  C) Freezer

  D) Cool

  E) Room

  F) Controlled

  G) Warm

  H) Excessive Heat

  
• Overage - “the voluntary introduction of a specific excess during the manufacture of pharmaceutical forms of medicaments that are unstable by nature and difficult to stabilize, in order to maintain during their period of use an active content within the limits compatible with therapeutic requirement”
• Manufacturing Overage - overage added to a preparation to compensate loss during manufacturing of the preparation; decrease stability profile during manufacturing process
• Stability Overage - is the excess added to a preparation to extend its shelf life
• Allowable Overage

  A) 15

  B) 15

  C) 20

  D) 25

  
• Graphical Method - is also the Free Hand Method
• Least Square Method - is based on Arrhenius Equation