Global climatic zone divisions for stability studies on pharmaceuticals

A pharmaceutical manufacturer has manufacturing facilities in single or multiple locations. However, the product can be consumed by patients at locations which can be spread within the country or even in markets across the world. It is natural to expect variations in climatic conditions in different locations so the question arises that will the shelf […]

Considerations in shelf life studies on Pharmaceuticals

A pharmaceutical product is manufactured with the objective of alleviating suffering through the role of the active drug ingredient. However, its effectiveness is limited over time due to natural degradation processes. The degradation is evaluated through shelf life studies. The shelf life is defined as the time over which the drug’s potency claim remains within […]

Significance of shelf life studies on food products

Foods are an essential requirement for sustenance of life. Primarily foods serve two main objectives. First and foremost is to provide us the energy to carry out our daily activities and secondly to satisfy our taste buds. However, all foods irrespective of their source – farm harvested or factory produced do not retain their attributes […]

Significance of shelf life studies on pharmaceutical products

Any medicinal product does not remain stable for all time. The potency or strength of the active ingredient drops over a period of time. Visually also formulations change and become discoloured, develop spots, becomes powdery or show other distinct changes so the concern arises as to how long after manufacture the formulation can be used […]

Parameters for Stability Studies on Cosmetics

Cosmetic products have been in use since time immemorial but in the recent past there has been an upsurge in demand for personal healthcare and beauty products due to increased awareness. USA and European Union were traditionally the leading markets but other developing economies have also contributed to market growth of such products. Regulatory bodies […]

Factors Resulting in Degradation of Food Products

Stability studies on pharmaceuticals were covered in an earlier article. Foods constitute another important area and are essential for sustenance of human and animal life. The present article covers some of the physico-chemical changes that take place in foods resulting in their deterioration. Used by date Vs Best before date Today superstores are flooded with […]

Essential Requirements for Conducting Stability studies on Pharmaceuticals

The prime objective of conducting stability studies on pharmaceutical dosage forms is to define the shelf life under recommended storage conditions. In the interest of patient safety the dosage form should be guaranteed for its quality, safety and efficacy throughout its shelf life under prescribed storage conditions. The shelf life should be decided taking into […]

Importance of Stability Studies

Apart from air and water humans require both natural and man-made commodities for sustenance. Foods and pharmaceuticals constitute the major chunk of such commodities.All manmade products for human consumption reach you with an expiry date which is decided by the manufacturer on the basis of stability of the product under normal storage conditions. Preservatives are […]