Skip to main content
SpringerLink
Log in

Guidelines for Drug Stability and Stability Testing

  • Chapter
  • First Online:
Drug Stability and Chemical Kinetics

  • 1073 Accesses

Abstract

Stability studies are pivotal necessities for ensuring safety, potency, and quality of drug products throughout their shelf-life. These guarantee that pharmaceutical products will remain stable and effective under the recommended storage conditions and are considered as prerequisite for approval of any pharmaceutical product. Stability tests are routine procedures that are conducted under different conditions for investigating the effect of variation in temperature, humidity, light intensity, and time on pharmaceutical products. Hence, these studies should be conducted and evaluated according to guidelines issued by ICH (International Conference on Harmonization) or WHO. In this chapter, we have discussed the types and methods of stability tests, storage conditions, as well as ICH and WHO guidelines.

This is a preview of subscription content, log in via an institution to check access.

Access this chapter

Log in via an institution
Chapter
USD 29.95
Price excludes VAT (USA)
  • Available as PDF
  • Read on any device
  • Instant download
  • Own it forever
eBook
USD 84.99
Price excludes VAT (USA)
  • Available as EPUB and PDF
  • Read on any device
  • Instant download
  • Own it forever
Softcover Book
USD 109.99
Price excludes VAT (USA)
  • Compact, lightweight edition
  • Dispatched in 3 to 5 business days
  • Free shipping worldwide - see info
Hardcover Book
USD 109.99
Price excludes VAT (USA)
  • Durable hardcover edition
  • Dispatched in 3 to 5 business days
  • Free shipping worldwide - see info

Tax calculation will be finalised at checkout

Purchases are for personal use only

Institutional subscriptions

References

  1. Preparations WECoSfP (2018) Stability testing of active pharmaceutical ingredients and finished pharmaceutical products. WHO Technical Report Series (1010)

    Google Scholar 

  2. Bajaj S, Singla D, Sakhuja N (2012) Stability testing of pharmaceutical products. J App Pharm Sci 2(3):129–138

    Google Scholar 

  3. Aashigari S, Goud R, Sneha S, Vykuntam U, Potnuri NR (2018) Stability studies of pharmaceutical products. World J Pharm Res 8:479–492

    Google Scholar 

  4. Siddiqui FA, Sher N, Shafi N, Wafa Sial A, Ahmad M, Naseem H (2014) Development of new method for simultaneous analysis of piracetam and levetiracetam in pharmaceuticals and biological fluids: application in stability studies. Biomed Res Int 2014

    Google Scholar 

  5. Jamrógiewicz M (2016) Consequences of new approach to chemical stability tests to active pharmaceutical ingredients. Front Pharmacol 7:17

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  6. World Health Organization, Meeting WECoSfPP (2015) WHO expert committee on specifications for pharmaceutical preparations: forty-ninth report. World Health Organization, Geneva

    Google Scholar 

  7. World Health Organization, Preparations WECoSfP (2017) Fifty-first report of the WHO Expert Committee on specifications for pharmaceutical preparations. World Health Organization, Geneva

    Google Scholar 

  8. World Health Organization (2011) Guidelines on submission of documentation for a multisource (generic) finished product: general format: preparation of product dossiers in common technical document format. WHO expert committee on specifications for pharmaceutical preparations Annex;5

    Google Scholar 

  9. Meeting WECoSfPP, World Health Organization (2016) WHO expert committee on specifications for pharmaceutical preparations: fiftieth report. World Health Organization, Geneva

    Google Scholar 

  10. Zilker M, Sörgel F, Holzgrabe U (2019) A systematic review of the stability of finished pharmaceutical products and drug substances beyond their labeled expiry dates. J Pharm Biomed Anal 166:222–235

    Article  CAS  PubMed  Google Scholar 

  11. Yasmeen A, Sofi G (2019) A review of regulatory guidelines on stability studies. J Phytopharmacol 8(3):147–151

    Article  Google Scholar 

  12. Rao G, Goyal A (2016) Development of stability indicating studies for pharmaceutical products: an innovative step. Int Jr Pharm Chem Anal 3(3):110–116

    Article  Google Scholar 

  13. Sautou V, Brossard D, Chedru-Legros V, Crauste-Manciet S, Lagarce F, Odou P (2013) Methodological guidelines for stability studies of hospital pharmaceutical preparations. SFPC GERPAC 75

    Google Scholar 

  14. Panda A, Kulkarni S, Tiwari R (2013) Stability studies: an integral part of drug development process. Int J Pharma Res Bio Sci 2(6):69–80

    Google Scholar 

  15. Narayan S, Choudhary M (2017) A review on stability studies of pharmaceutical products. Int J of Appl Pharm Bio Res 2(3):67–75

    CAS  Google Scholar 

  16. Singh DK, Singh S, Bajaj S (2018) Regulatory guidelines on stability testing and trending of requirements. Methods for stability testing of pharmaceuticals. Springer, New York, pp 1–30

    Google Scholar 

  17. Thorat P, Warad S, Solunke R, Sargar A, Bhujbal A, Shinde A (2014) Stability study of dosage form: an innovative step. World J Pharm Pharm Sci 3(2):1031–1050

    Google Scholar 

  18. Bajaj S, Singh S. (2018) Methods for stability testing of pharmaceuticals: Springer. New York

    Google Scholar 

  19. Pokharana M, Vaishnav R, Goyal A, Shrivastava A (2018) Stability testing guidelines of pharmaceutical products. J Drug Deliv Ther 8(2):169–175

    Google Scholar 

  20. Lachman L, Lieberman HA, Kanig JL (1986) The theory and practice of industrial pharmacy. Lea & Febiger, Philadelphia

    Google Scholar 

  21. Bott RF, Oliveira WP (2007) Storage conditions for stability testing of pharmaceuticals in hot and humid regions. Drug Dev Ind Pharm 33(4):393–401

    Article  CAS  PubMed  Google Scholar 

  22. Honmane SM (2017) General considerations of design and development of dosage forms: pre-formulation review. Asian J Pharm 11:03

    Google Scholar 

  23. Shah AK, Agnihotri SA (2011) Recent advances and novel strategies in pre-clinical formulation development: an overview. J Control Release 156(3):281–296

    Article  CAS  PubMed  Google Scholar 

  24. Garnero C, Zoppi A, Aloisio C, Longhi MR (2018) Technological delivery systems to improve biopharmaceutical properties. In: Nanoscale fabrication, optimization, scale-up and biological aspects of pharmaceutical nanotechnology. Elsevier, Oxford, pp 253–299

    Chapter  Google Scholar 

  25. Zhou D, Porter WR, Zhang GG (2009) Drug stability and degradation studies. In: Developing solid oral dosage forms. Elsevier, pp 87–124

    Google Scholar 

  26. Qiu Y, He X, Zhu L, Chen B (2017) Product and process development of solid oral dosage forms. In: Developing solid oral dosage forms. Elsevier, pp 555–591

    Google Scholar 

  27. Zhou D, Qiu Y (2010) Understanding drug properties in formulation and process design of solid oral products. J Valid Technol 16(4):74

    Google Scholar 

  28. Denyer SP, Hodges NA, Gorman SP (2008) Hugo and Russell’s pharmaceutical microbiology. Wiley, New York

    Google Scholar 

  29. Sandle T (2011) A review of cleanroom microflora: types, trends, and patterns. PDA J Pharm Sci Technol 65(4):392–403

    Article  PubMed  Google Scholar 

  30. Dao H, Lakhani P, Police A, Kallakunta V, Ajjarapu SS, Wu K-W et al (2018) Microbial stability of pharmaceutical and cosmetic products. AAPS PharmSciTech 19(1):60–78

    Article  CAS  PubMed  Google Scholar 

  31. Bhagyashree P, Karishma G, Sampada A, Ankita P, Pratibha C, Kailash V (2015) Recent trends in stability testing of pharmaceutical products: a review. Res J Pharm Biol Chem Sci 6(1):1557–1569

    Google Scholar 

  32. Blessy M, Patel RD, Prajapati PN, Agrawal Y (2014) Development of forced degradation and stability indicating studies of drugs—a review. J Pharm Anal 4(3):159–165

    Article  CAS  PubMed  Google Scholar 

  33. Abellán EFG, Pérez DM (2018) Quality control of cosmetic products: specific legislation on ingredients. In: Analysis of cosmetic products. Elsevier, pp 39–53

    Google Scholar 

  34. Lerche D, Sobisch T (2011) Direct and accelerated characterization of formulation stability. J Dispers Sci Technol 32(12):1799–1811

    Article  CAS  Google Scholar 

  35. Lin T-YD, Chen CW (2003) Overview of stability study designs. J Biopharm Stat 13(3):337–354

    Article  PubMed  Google Scholar 

  36. Kopp S (2006) Stability testing of pharmaceutical products in a global environment. Regul Aff J 16(5):291–294

    Google Scholar 

  37. Huynh-Ba K (2009) Pharmaceutical stability testing to support global markets. Springer, New York

    Google Scholar 

  38. Kaur M, Kaur G, Kaur H, Sharma S (2013) Overview on stability studies. Int J Pharm Chem Biol Sci 3:4

    Google Scholar 

  39. Khan H, Ali M, Ahuja A, Ali J (2010) Stability testing of pharmaceutical products-comparison of stability testing guidelines. Curr Pharm Anal 6(2):142–150

    Article  CAS  Google Scholar 

  40. Teasdale A, Elder D, Nims RW (2017) ICH quality guidelines. Wiley Online Library, Hoboken

    Google Scholar 

  41. Elder D, Teasdale A (2017) ICH Q9 quality risk management. In: ICH quality guidelines: an implementation guide. Wiley, Hoboken, pp 579–610

    Chapter  Google Scholar 

  42. Chinchole AS, Poul B, Panchal C, Chavan D (2014) A review on stability guidelines by ICH and USFDA guidelines for new formulation and dosage form. PharmaTutor 2(8):32–53

    Google Scholar 

  43. Guideline IHT (2003) Stability testing of new drug substances and products. Q1A (R2), current step 4:1–24

    Google Scholar 

  44. Eggert J, Fowler C (2008) Conducting stability studies during development to ensure successful regulatory approval. Drugs Pharm Sci 181:207

    Google Scholar 

  45. Bhavyasri K, Vishnumurthy KM, Rambabu D, Sumakanth M (2019) ICH guidelines–“Q” series (quality guidelines)-A review. GSC Biol Pharm Sci 6(3):089–106

    Article  Google Scholar 

  46. Baertschi SW, Alsante KM, Tønnesen HH (2010) A critical assessment of the ICH guideline on photostability testing of new drug substances and products (Q1B): recommendation for revision. J Pharm Sci 99(7):2934–2940

    Article  CAS  PubMed  Google Scholar 

  47. Huynh-Ba K (2008) Handbook of stability testing in pharmaceutical development: regulations, methodologies, and best practices. Springer, New York

    Google Scholar 

  48. Huynh-Ba K (2009) Stability operation practices. Handbook of stability testing in pharmaceutical development. Springer, New York, pp 303–320

    Book  Google Scholar 

  49. Subbarao N, Huynh-Ba K (2009) Evaluation of stability data. Handbook of stability testing in pharmaceutical development. Springer, pp 263–283

    Google Scholar 

  50. Capen R, Christopher D, Forenzo P, Huynh-Ba K, LeBlond D, Liu O et al (2018) Evaluating current practices in shelf life estimation. AAPS PharmSciTech 19(2):668–680

    Article  PubMed  Google Scholar 

  51. Avohou TH, Lebrun P, Rozet E, Boulanger B (2020) Bayesian methods for the design and analysis of stability studies. In: Bayesian methods in pharmaceutical research

    Google Scholar 

  52. Stroup WW, Quinlan M (2016) Statistical considerations for stability and the estimation of shelf life. Nonclinical statistics for pharmaceutical and biotechnology industries. Springer, Cham, pp 575–604

    Google Scholar 

  53. Mazzeo A, Carpenter P (2009) Stability studies for biologics. In: Huynh-Ba K (ed) Handbook of stability testing in pharmaceutical development. Springer, New York, pp 353–369

    Chapter  Google Scholar 

  54. Toth SJ (2014) Nonlinear optical imaging of pharmaceutical formulations. Purdue University

    Google Scholar 

  55. Bajaj S, Singla D, Sakhuja N (2012) Stability testing of pharmaceutical products. J App Pharm Sci 2(3):129–138

    Google Scholar 

  56. Centanni JM, Roy MJ (2016) Biotechnology operations: principles and practices. CRC Press, Boca Raton

    Book  Google Scholar 

  57. Kumar N, Jha A (2017) Temperature excursion management: a novel approach of quality system in pharmaceutical industry. Saudi Pharm J 25(2):176–183

    Article  PubMed  Google Scholar 

  58. Narang AS, Desai D, Badawy S (2015) Impact of excipient interactions on solid dosage form stability. Excipient applications in formulation design and drug delivery. Springer, pp 93–137.

    Google Scholar 

  59. Hanlon G, Hodges NA (2012) Essential microbiology for pharmacy and pharmaceutical science. Wiley, Chichester

    Google Scholar 

  60. Mohamed AI, Abd-Motagaly AME, Ahmed OA, Amin S, Ali M, Ibrahim A (2017) Investigation of drug–polymer compatibility using chemometric-assisted UV-spectrophotometry. Pharmaceutics 9(1):7

    Article  CAS  PubMed Central  Google Scholar 

  61. Murthy SN, Repka MA (2018) Excipient stability: a critical aspect in stability of pharmaceuticals. AAPS Pharm Sci Tech 19(1):11–11

    Article  CAS  Google Scholar 

Download references

Author information

Authors and Affiliations

  1. Department of Pharmacy, University of Agriculture, Faisalabad, Pakistan

    Kamran Haider, Amna Faheem & Kanwal Rehman

  2. Department of Pharmaceutical Chemistry, Government College University, Faisalabad, Pakistan

    Muhammad Sajid Hamid Akash

  3. Institute of Physiology and Pharmacology, University of Agriculture, Faisalabad, Pakistan

    Amna Faheem

Authors
  1. Kamran Haider
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. Muhammad Sajid Hamid Akash
    View author publications

    You can also search for this author in PubMed Google Scholar

  3. Amna Faheem
    View author publications

    You can also search for this author in PubMed Google Scholar

  4. Kanwal Rehman
    View author publications

    You can also search for this author in PubMed Google Scholar

Corresponding author

Correspondence to Kanwal Rehman .

Editor information

Editors and Affiliations

  1. Department of Pharmaceutical Chemistry, Government College University, Faisalabad, Pakistan

    Muhammad Sajid Hamid Akash

  2. Department of Pharmacy, University of Agriculture, Faisalabad, Pakistan

    Kanwal Rehman

Rights and permissions

Reprints and permissions

Copyright information

© 2020 The Editor(s) (if applicable) and The Author(s), under exclusive license to Springer Nature Singapore Pte Ltd.

About this chapter

Check for updates. Verify currency and authenticity via CrossMark

Cite this chapter

Haider, K., Akash, M.S.H., Faheem, A., Rehman, K. (2020). Guidelines for Drug Stability and Stability Testing. In: Akash, M.S.H., Rehman, K. (eds) Drug Stability and Chemical Kinetics. Springer, Singapore. https://doi.org/10.1007/978-981-15-6426-0_2

Download citation

Publish with us

Policies and ethics

Search

Navigation