38. Quality control in drug stability

Quality Control in Drug Stability

Drug stability is a critical aspect of pharmaceutical quality control. Refers to the ability of a drug to maintain its physical, chemical, therapeutic and microbiological properties within specified limits throughout its shelf life. The stability study provides evidence on how the quality of a drug varies over time under the influence of a variety of environmental factors such as temperature, humidity and light, and allows the recommendation of storage conditions and expiry dates.

Importance of Quality Control in Drug Stability

The stability of a drug is essential to ensure that it retains its desired properties until the end of its shelf life. An unstable drug can degrade, resulting in reduced efficacy and potentially the formation of toxic breakdown products. Therefore, quality control on drug stability is crucial to ensure drug safety and efficacy.

Stability Tests

Stability testing is an essential part of pharmaceutical quality control. They involve storing drug samples under controlled conditions and regularly monitoring their stability over time. Stability testing can be long-term, where drugs are tested for extended periods under normal storage conditions, or accelerated, where drugs are tested under stress conditions to predict their long-term stability.

Quality Control Parameters

Quality control parameters in drug stability include physical appearance such as color and clarity, pH, dissolution, impurities, and potency. The physical appearance of a drug can change over time, indicating possible instability. pH can affect the stability of a drug, and changes in pH can indicate degradation. Dissolution is an indicator of the amount of drug available for absorption, and a decrease in dissolution can indicate instability. Impurities can form as a drug breaks down, and an increase in impurities can indicate instability. The potency of a drug can decrease over time, indicating degradation and instability.

Conclusion

In conclusion, quality control of drug stability is a vital aspect of pharmacology and pharmaceutical quality control. It ensures that medicines are safe and effective throughout their shelf life, thus protecting the health and well-being of patients.

Next page of the Free Ebook:

39Quality control in pharmaceutical packaging

2 minutes