Asian guidelines stability

Quality consistencies of drug products are essential to guarantee expected therapeutic activities, and achieving consistent qualities for herbal products is challenging because of their physicochemical complexities and inherent variabilities. Regulatory authorities worldwide have issued regulations or guidelines for stability testing parameters and testing procedures for herbal products stored in proposed conditions. Physical, chemical, and biological stability tests were compared between different dosage forms, and the testing conditions temperature and relative humidity used for long-term, accelerated, or intermediate testing were included in the guidelines and regulations. Comparisons of global regulations and guidelines addressing stability testing are fundamental for the international harmonization of herbal product quality assessments. This review aids understanding of the global situation regarding the testing of herbal product quality with respect to storages.

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Global Comparison of Stability Testing Parameters and Testing Methods for Finished Herbal Products

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Global Comparison of Stability Testing Parameters and Testing Methods for Finished Herbal Products

Stability studies must be carried out according to the guidelines provided by the International Conference of Harmonization, World Health Organization, and other agencies in a scheduled manner. It also guarantees that the performance, safety, and efficacy are maintained throughout the shelf life of any pharmaceutical product which is considered as pre-requisite for acceptance and approval. Different stability test methods have originated with the need for constant monitoring of drugs and products for their quality and purity. In this review, we have included the types of stability of drugs substances, the relevance of different methods used to test the stability of the pharmaceutical product, guidelines issued to test the stability of pharmaceuticals, stability testing protocols which describes the main components of a well-controlled and regulated stability test and other aspects of stability. This work is licensed under a Creative Commons Attribution 4. The publication is licensed under CC By and is open access. Copyright is with author and allowed to retain publishing rights without restrictions.
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