Your browser does not fully support modern features. Please upgrade for a smoother experience.
Submitted Successfully!
Thank you for your contribution! You can also upload a video entry or images related to this topic. For video creation, please contact our Academic Video Service.
Version Summary Created by Modification Content Size Created at Operation
1 Yu Peng -- 228 2026-10-25 15:42:08 |
2 delete taxonomy path Yu Peng -9 word(s) 219 2026-10-25 15:42:19 |

Video Upload Options

We provide professional Academic Video Service to translate complex research into visually appealing presentations. Would you like to try it?
Cite
If you have any further questions, please contact Encyclopedia Editorial Office.
Peng, Y. Drug Stability. Encyclopedia. Available online: https://encyclopedia.pub/entry/61481 (accessed on 12 November 2026).
Peng Y. Drug Stability. Encyclopedia. Available at: https://encyclopedia.pub/entry/61481. Accessed November 12, 2026.
Peng, Yu. "Drug Stability" Encyclopedia, https://encyclopedia.pub/entry/61481 (accessed November 12, 2026).
Peng, Y. (2026, October 25). Drug Stability. In Encyclopedia. https://encyclopedia.pub/entry/61481
Peng, Yu. "Drug Stability." Encyclopedia. Web. 25 October, 2026.

Drug Stability

Edit

Drug stability designates the capacity of a pharmaceutical substance or dosage form, within specified limits and throughout its period of storage and use, to retain the same properties and characteristics that it possessed at the time of manufacture. The concept is operationally partitioned into chemical stability, in which each active ingredient retains its chemical integrity and labelled potency, and physical stability, in which the original physical properties—appearance, uniformity, dissolution, and suspendability—are preserved [1]. Chemical degradation proceeds through defined pathways whose relative contributions depend on the molecular structure and the formulation environment: hydrolysis of ester, amide, and lactam bonds is accelerated by moisture and adverse pH; oxidation involves reaction with molecular oxygen and is promoted by trace metals, light, and elevated temperature; photolysis results from absorption of ultraviolet or visible radiation; and epimerization, isomerization, and polymerization constitute further routes of chemical change [2]. The environmental factors that reduce stability include temperature, light, humidity, oxygen, and carbon dioxide, while the dosage-form factors include particle size, pH, solvent composition, ionic strength, container, and excipient compatibility [1]. The term therefore denotes the property of a formulated pharmaceutical product—defined by its chemical and physical integrity under defined storage conditions—together with the degradation mechanisms and formulation variables that determine the shelf-life within which that integrity is maintained [2][3][4].

Chemical stability physical stability degradation pathway shelf-life
Help expand this entry Share your expertise by adding detailed content and references to improve this entry.
Add content

References

  1. Qudsia Rehman; Muhammad Sajid Hamid Akash; Imran Imran; Kanwal Rehman. Stability of Pharmaceutical Products; Springer Nature: Durham, NC, United States, 2020; pp. 147-154. [CrossRef]
  2. Kenneth C. Waterman; Roger C. Adami; Accelerated aging: Prediction of chemical stability of pharmaceuticals. Int. J. Pharm. 2005, 293, 101-125. [CrossRef]
  3. M Blessy; Ruchi D. Patel; Prajesh N. Prajapati; Y.K. Agrawal; Development of forced degradation and stability indicating studies of drugs—A review. J. Pharm. Anal. 2014, 4, 159-165. [CrossRef]
  4. Benedito Roberto de Alvarenga Junior; Renato Lajarim Carneiro; Chemometrics Approaches in Forced Degradation Studies of Pharmaceutical Drugs. Molecules 2019, 24, 3804. [CrossRef]
More
Upload a video for this entry
Information
Contributor MDPI registered users' name will be linked to their SciProfiles pages. To register with us, please refer to https://encyclopedia.pub/register : Yu Peng
View Times: 7
Revisions: 2 times (View History)
Update Date: 25 Oct 2026
Notice
You are not a member of the advisory board for this topic. If you want to update advisory board member profile, please contact office@encyclopedia.pub.
OK
Confirm
Only members of the Encyclopedia advisory board for this topic are allowed to note entries. Would you like to become an advisory board member of the Encyclopedia?
Yes
No
${ textCharacter }/${ maxCharacter }
Submit
Cancel
There is no comment~
${ textCharacter }/${ maxCharacter }
Submit
Cancel
${ selectedItem.replyTextCharacter }/${ selectedItem.replyMaxCharacter }
Submit
Cancel
Confirm
Are you sure to Delete?
Yes No
Write an Entry