By Yukihiro Shoyama

ISBN-10: 9533076828

ISBN-13: 9789533076829

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The main objective of a stability indicating method is to monitor results during stability studies in order to guarantee safety, efficacy and quality. , 2004) or out-of-specification (OOS) results (CDER, 2006) in quality control processes. 2 How develop a SIM? 1 Step 1: generation of degraded samples for testing selectivity of the method Here lies one of the main concerns related to a development of a SIM, since the available guidance documents do not state the extent to which stress tests should be carried out – that is, how much stress should be applied or how much degradation should be aimed for.

5. Identifying critical points and stages of changes in order to build the SAFES process diagram. 6. Building matrices: descriptive, transformed and matrix of change. For the construction of these matrices it is necessary to use experimental data obtained in the laboratory or referred to in the literature, and assume simplifying hypotheses to solve those situations where no data are available. 1 Experimental work needed to apply the SAFES methodology Electromicroscopy In order to properly describe the structure of the product, samples of fresh sugar beet and those collected during the experimental extraction (30 and 60 minutes processed) were 46 Quality Control of Herbal Medicines and Related Areas examined using electron microscopy at low temperatures (CryoSEM).

Alder, B. , Fish, R. , Cook, J. , Glose, K. , Carmody, J. , Grassi, J. , Cheng, Y. , (1999), Use of high performance LC packings from pH1 to pH 12. Am. Lab, 31-36. ISSN: 00447749. Ngwa, G. (2010). Forced Degradation Studies. , vol. 10 No. 3, June, ISSN 0976-1225. Reynolds, D. W. (2004). Forced Degradation of Pharmaceuticals. Am. Pharm. Rev, May/June, 56-61, ISSN : 1099-8012. Reynolds, D. ; Facchine, K. , Mullaney, F. , Alsante, K. , D. & Motto, M. (2002). Available Guidance and Best Practices for Conducting Forced Degradation Studies.

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Quality Control of Herbal Medicines and Related Areas by Yukihiro Shoyama


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