Understanding and Predicting Pharmaceutical Product Shelf-Life

  • Kenneth C. Waterman


Pharmaceutical products are assigned a shelf-life which determines the time when a product is considered to be safe and effective under a relevant storage condition. A number of factors are used to assign that shelf-life. Among these factors are the chemical stability of the active pharmaceutical ingredient (API) in its dosage form, and specifically whether any degradation products are potentially hazardous to a patient. In addition, any factors which affect an API’s bioavailability can also limit shelf-life. These factors not only include loss of API potency due to degradation, but also loss of activity due to precipitation (for liquid dosage forms) or slowing of API release in the gastrointestinal tract. Accelerating the aging process allows the development and production of pharmaceutical products without waiting for the entire shelf-life to elapse before assigning a value. Such factors as temperature and relative humidity can be used to accelerate these processes effectively allowing for accurate and precise predictions.


Dosage Form Drug Product Active Pharmaceutical Ingredient Physical Stability Solid Dosage Form 
These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.


Unable to display preview. Download preview PDF.

Unable to display preview. Download preview PDF.


  1. 1.
    ICH Harmonised Tripartite Guideline: Stability Testing of New Drug Substances and Products,
  2. 2.
    Singhal, D.; Curatolo, W. Drug polymorphism and dosage form design: a practical perspective. Adv. Drug Delivery Rev. 56(3) (2004) 335–347.CrossRefGoogle Scholar

Additional Resources

  1. Airaksinen S, Karjalainen M, Shevchenko A, Westermarck S, Leppanen E, Rantanen J, Yliruusi J (2005) Role of water in the physical stability of solid dosage formulations. J Pharm Sci 94(10): 2147–2165.CrossRefPubMedGoogle Scholar
  2. Bauer M (2005) Stability of drug substances and drug products: considerations on the stability of drug substances and formulation in the pharmaceutical industry domain. STP Pharma Pratiques, 15(3):232–246.Google Scholar
  3. Carstensen JT (2000) Solution kinetics. Drugs Pharm Sci 107 (Drug Stability) pp. 19–55.Google Scholar
  4. Guerrieri P, Salameh AK, Taylor LS (2007) Effect of small levels of impurities on the water vapor sorption behavior of ranitidine HCl. Pharm Res 24(1):147–156.CrossRefPubMedGoogle Scholar
  5. Guillory JK, Poust RI (2002) Chemical kinetics and drug stability. Drugs Pharm Sci 121 (Modern Pharmaceutics, 4th Edition) pp. 139–166.Google Scholar
  6. Li S, Wei B, Fleres S, Comfort A, Royce A (2004) Correlation and prediction of moisture-mediated dissolution stability for benazepril hydrochloride tablets. Pharm Res 21(4):617–624.CrossRefPubMedGoogle Scholar
  7. Pogocki D, Schoneich C (2000) Chemical stability of nucleic acid-derived drugs. J Pharm Sci 89(4):443–456.CrossRefPubMedGoogle Scholar
  8. Waterman KC, Adami RC (2005) Accelerated aging: prediction of chemical stability of pharmaceuticals. Inter J Pharm 293:101–125.CrossRefGoogle Scholar
  9. Waterman KC, Adami RC, Alsante KM, Antipas AS, Arenson DR, Carrier R, Hong J, Landis MS, Lombardo F, Shah JC, Shalaev EY, Smith SW, Wang H (2002) Hydrolysis in pharmaceutical formulations. Pharm Dev Tech 7:113–146.CrossRefGoogle Scholar
  10. Waterman KC, Adami RC, Alsante KM, Hong J, Landis MS, Lombardo F, Roberts CJ (2002) Stabilization of pharmaceuticals to oxidative degradation. Pharm Dev Tech 7:1–32.CrossRefGoogle Scholar
  11. Waterman KC, Carella AJ, Gumkowski MJ, Lukulay P, MacDonald BC, Roy MC, Shamblin SL (2007) Improved protocol and data analysis for accelerated shelf-life estimation of solid dosage forms. Pharm Res 24(4):780–790.CrossRefPubMedGoogle Scholar

Copyright information

© Springer Science+Business Media, LLC 2009

Authors and Affiliations

  1. 1.Pfizer Global Research and DevelopmentGrotonUSA

Personalised recommendations