Stability Studies Of Pharmaceutical and Cosmetic Products

The purpose of stability testing is to provide evidence on how the quality of an active pharmaceutical ingredient or medicinal product varies with time under the influence of a variety of environmental factors such as temperature, humidity, and light, and to establish a re-test period for the active pharmaceutical ingredient or a shelf life for the medicinal product and recommended storage conditions. The design of the stability-testing programme should take into account the intended market and the climatic conditions in the area in which the medicinal products will be used. The stability testing recommendations in this guideline cover the long-term storage condition for all Climatic Zones, i.e. I – IV. The shelf life should be established with due regard to the climatic zone(s) in which the products are to be marketed. For certain preparations, the shelf-life can be guaranteed only if specific storage instructions are complied with.

Regulations of all countries lay emphasis on stability studies. Rightly so, a product manufactured & distributed should remain stable till date of expiry mentioned on the label so that it remains safe and efficacious for use. Date of expiry is given on the basis of stability studies.

There are national, regional and international guidelines on stability studies of pharmaceutical products. All these guidelines have been discussed in the book. A formulation development and quality control chemist should have knowledge of different factors which affect stability of pharmaceutical and cosmetic products. These have been included in the book.

There is little literature on stability of cosmetic products and how these should be carried out. After searching useful information has been complied on the subject.

Since excipients are important components of pharmaceutical formulation, their stability profile can have significant influence on finished pharmaceutical products (FPPs). Discussion on the guidelines laid down by the International Pharmaceutical Excipient Council (IPEC) would be useful to the readers of the book.

The book is compilation of different guidelines on the stability of active pharmaceutical ingredients (APIs) and finished pharmaceutical products (FPPs), excipients and cosmetics.

The book will be useful to:

• Technical Staff of Pharmaceutical Industry
• Pharmacy Colleges Faculty & Students
• Staff of Contract-Research Organization (CROs)
• Regulatory Officers
• Consultants