ABSTRACT

Herbal products are becoming more popular over time and are seen to have enormous potential. The majority of herbal products contain many components. Because of the nature of the multi-ingredients, herbal products can be unstable. As a result of changing moisture levels, herbal products are in fact more susceptible to microbial deterioration. The stability of the herbal product is evaluated by International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use ICH guidelines for registration of pharmaceuticals for human use. An herbal product needs to have real-time and accelerated stability data which give the product’s interim conditions at the time of transportation, while real-time stability data gives the product’s actual life span. The conditions for stability studies, final pharmaceutical products, and active pharmaceutical components are described in this chapter.