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Tổng quan về các kỹ thuật phân tích sử dụng trong thiết lập chất chuẩn gốc (primary standard)

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13. Blessy M, Ruchi D. Patel, et al. (2014), "Development of forced degradation and<br />

stability indicating studies of drugs-A review", Journal of Pharmaceutical Analysis,<br />

4(3), pp.159-165.<br />

14. British Pharmacopoeia Commission (2014), The British pharmacopoeia<br />

Stationery Office Books (TSO).<br />

15. Brown M. E. (1979), "Determination of purity by differential scanning<br />

calorimetry (DSC)", Journal of Chemical Education 56(5), pp.310-313.<br />

16. Bruni G., Berbenni V., et al. (2011), "Determination of the nateglinide<br />

polymorphic purity through DSC", Journal of Pharmaceutical and Biomedical Analysis,<br />

54(5), pp.1196-1199.<br />

17. Charde M.S., Kumar Jitendra, et al. (2013), "Review: Development of forced<br />

degradation studies of drugs", International Journal of Advances in Pharmaceutics,<br />

2(3), pp.1-5.<br />

18. Christian Zeine, LGC Standards GmbH (2013), Primary/secondary <strong>standard</strong>s in<br />

pharmaceutical QC, LGC <strong>standard</strong>s, pp.1-40.<br />

19. Chung Chow Chan, Herman Lam, et al. (2004), Analytical Method Validation<br />

and Instrument Performance Verification- Chapter 3: Method Validation for HPLC<br />

Analysis of Related Substances in Pharmaceutical Drug Products, pp.27-48.<br />

20. Committee on Asean reference substance (2005), Guidelines for the<br />

establishment, handling, storage and use of Asean reference substances, Thailand, pp.2-<br />

12.<br />

21. David C.Browne (2009), "Reference Standard Material Qualification",<br />

Pharmaceutical Technology,, 33(4), pp.1-6.<br />

22. David Kealey, P J Haines (2002), Instant Notes in Analytical Chemistry, pp.270-<br />

282, 302-304.<br />

23. EDQM Council of Europe (2018), from<br />

https://www.edqm.eu/en/news/reference-<strong>standard</strong>s.<br />

24. European Directorate for the Quality of Medicines & HealthCare (EDQM)<br />

DIỄN ĐÀN TOÁN - LÍ - HÓA 1000B TRẦN HƯNG ĐẠO TP.QUY NHƠN<br />

(2015), Annual Report, Council of Europe EDQM, pp.1-44.<br />

25. European Directorate for the Quality of Medicines & HealthCare (EDQM)<br />

(2016), Annual Report, Council of Europe EDQM, pp.1-43.<br />

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