Jenny lauper

Drug Stability

A short piece about drug stability, drug efficacy and drug bioavailability, their use and practical examples

Drug stability refers to the ability of a drug to remain unchanged and maintain the specifications of its quality, purity, strength and activity till its expiration date or retest date. The measure of stability is very important to establish drug safety, drug efficacy and drug bioavailability. Stability testing is important to ensure that a drug will remain effective and safe during its shelf life. Instability can result in alteration of the physical (dissolution rate, hardness, friability) and chemical characteristics of a drug. 

The chemical stability of a drug is very important as drug degradation can result in the production of potentially toxic substances.

Stability assessment is an essential procedure made mandatory by drug regulatory authorities all over the world. The testing establishes the quality of the drug and provides evidence that the drug will remain stable under variable storage conditions (temperature, humidity). The testing is performed on the drug as well as its packaging. Packaging material that comes in contact with the drug can influence the stability of the drug.

Drug stability testing has become more important today because drugs made in one part of the world are transported to various other countries under changing climatic zones. Stability testing results in generation of data for physical, chemical and microbiological properties of the drug. The stability assessment is especially important for drug products that require storage at controlled temperatures.

If the routine testing procedures can determine the stability of the drug, additional distribution studies are not required. However, if distribution stability studies are required, they have to be conducted to check the drug’s limitations.

Stability studies performed on drugs are of two types, namely long-term stability study and accelerated stability study. Stability issues can result in recall of products from markets that proves very costly for companies. Thus, proper drug stability testing is very important to maintain drug safety standards.

Article Tags: Drug Stability, Very Important, Stability Testing

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