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Stability Testing Issues and Test Parameters for Herbal Medicinal Products

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Methods for Stability Testing of Pharmaceuticals

Part of the book series: Methods in Pharmacology and Toxicology ((MIPT))

Abstract

With increase in demand for herbal medicinal products, the supply of such drugs and products has increased tremendously in the market, particularly in the developing world. To keep a check on the quality, safety, and efficacy of these products, drugs regulators across the globe have issued international as well as national level guidelines specific for such products. Shelf-life assignment of these products is one of the critical parameters for ensuring their quality, safety and efficacy. These guidelines across the globe recommend assigning of the shelf-life to these products on the basis of stability testing. But performing such testing on herbal products is not as convenient as with synthetic drug products. The major issues pertaining to reliable and effective conduct of stability testing on herbal medicinal products are significant variations of quality of herbal raw material responsible for batch-to-batch variation; lack of identification and availability of therapeutic markers; changing chromatographic fingerprints due to inter- and intra-molecular interactions among the phytoconstituents, and stability of the latter. In addition to these, selection of test parameters exerts a considerable influence on reliability of data generated for assessment of the shelf-life. Because therapeutic activity of a herbal medicinal product is not ascribed solely to particular marker(s), monitoring of both chemical parameters and intended biological activity(ies) is suggested to be a part of stability testing program of herbal medicinal products.

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Authors and Affiliations

  1. Department of Pharmaceutical Sciences and Drug Research, Punjabi University, Patiala, Punjab, India

    Gulshan Bansal, Jasmeen Kaur, Nancy Suthar, Sarabjeet Kaur & Rahul Singh Negi

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  1. Gulshan Bansal
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  2. Jasmeen Kaur
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  3. Nancy Suthar
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  4. Sarabjeet Kaur
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  5. Rahul Singh Negi
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Correspondence to Gulshan Bansal .

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Editors and Affiliations

  1. Select Biosciences India Private Limited, Chandigarh, India

    Sanjay Bajaj

  2. Department of Pharmaceutical Analysis, National Institute of Pharmaceutical Education and Research (NIPER), Mohali, Punjab, India

    Saranjit Singh

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Bansal, G., Kaur, J., Suthar, N., Kaur, S., Negi, R.S. (2018). Stability Testing Issues and Test Parameters for Herbal Medicinal Products. In: Bajaj, S., Singh, S. (eds) Methods for Stability Testing of Pharmaceuticals. Methods in Pharmacology and Toxicology. Humana Press, New York, NY. https://doi.org/10.1007/978-1-4939-7686-7_14

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  • DOI: https://doi.org/10.1007/978-1-4939-7686-7_14

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  • Publisher Name: Humana Press, New York, NY

  • Print ISBN: 978-1-4939-7685-0

  • Online ISBN: 978-1-4939-7686-7

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