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Stability of a pharmaceutical product is defined as the capability of a particular formulation in a specific container/closure system to remain within its physical, chemical, microbiological, toxicological, protective and informational specifications. Thus it is very important to ensure that a raw material/finished product must be stable during the period of use and its storage. Stability testing of pharmaceutical products is a set of procedures ensuring quality, efficacy and safety in a raw material and finished formulation. Stability testing is an important requirement for regulatory approval of any drug in many countries. Generally herbal products are considered as safe. It is a myth. Various countries have limited use of plant based formulations because of lack of its stability, safety, efficacy and toxicity data. This work describes the stability testing of one such phyto constituent Ursolic acid according to ICH guideline. This work can help future studies of such type for other compounds of plant origin and to document the proof of its safety, efficacy and stability in the favour of patient compliance.
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Mr. Niraj Vyas is Post Graduate in Phytopharmaceuticals and Natural Products. He is a gold Medalist in his PG studies. His research areas includes Development and method validation for estimation of herbal compounds in raw materials and herbal formulations.His area of doctoral study is aphrodisiac & spermatogenic herbal drugs.
