The stability of finished pharmaceutical products is influenced by a variety of environmental elements such as temperature, humidity and light and product-related factors like chemical and physical properties of the active ingredient and pharmaceutical excipients, the dosage form and its composition, the manufacturing process, the design of the container-closure system, and the characteristics of the packaging materials.

Since the formulation and packaging-closure system that the manufacturer chooses will have a significant impact on the actual stability of a dosage form, stability considerations such as excipient selection, excipient level determination and process development should be given high priority during the product’s development phase.

It is also necessary to look at any potential interactions between the drug product and the packaging materials used for delivery, storage, and transportation during its shelf life.

The shelf-life should be chosen with consideration for the climate zone(s) where the product will be sold. If precise storage requirements are followed, the shelf-life of some preparations can only be guaranteed.

In order to maintain a product’s quality, safety, and effectiveness throughout its shelf life, manufacturers should follow the storage recommendations made on the basis of stability studies. The impact on products of the severely unfavorable climatic conditions presents in some places where they may be shipped calls for special study.

In order to guarantee both patient safety and the rational management of medicine supply, it requires that the expiration date and necessary storage conditions are stated on the label.


Studies carried out as part of the official stability testing programme that aim to speed up the rate of chemical deterioration and physical change of a medicine by employing inflated storage conditions. The information gathered in this way, along with that from real-time stability studies, can be used to assess longer-term chemical effects under nonaccelerated conditions and to gauge the effects of brief departures from the label-recommended storage conditions, such as those that might take place during shipping. The outcomes of accelerated testing studies are not always anticipatory of physical changes.

The accelerated stability testing data are at 40°C/ 75% for minimum 6 months than it can be assigned the shelf life of 24 months.


Studies on a drug’s physical, chemical, biological, biopharmaceutical, and microbiological properties during and after the sample’s anticipated shelf life and storage times under the storage conditions anticipated for the target market. The findings are applied to determine shelf-life, validate estimated shelf-life, and suggest storage conditions.

Long term stability testing data at 30°C/ 65% for minimum 12 months should be available at time of submission for new drug application and be continued further.

The shelf life of 36 months or more can be assigned to the drug formulation after completion of long-term stability studies.


Every country in the world has a unique climate. According to the nation’s climate, stability studies for pharmaceutical drugs should be conducted. The world’s climate is split into five different zones in accordance with the ICH criteria for stability studies.

ZonesType of Climate
Zone ITemperate zone
Zone I IMediterranean/subtropical zone
Zone I I IHot dry zone
Zone IV aHot humid/tropical zone
Zone IV bHot/higher humidity