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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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41. International Laboratory Accreditation Cooperation (ILAC) G12 (2000),<br />

Guidelines for the requirements for the competence of reference materials producers,<br />

pp.6-7.<br />

42. International Organization for Standardization 13528 (2005), Statistical methods<br />

for use in proficiency testing by interlaboratory comparisons.<br />

43. International Organization for Standardization (2015), ISO Guide 30:2015<br />

Reference materials - Selected terms and definitions.<br />

44. International Organization for Standardization (2017), ISO Guide 35: Reference<br />

materials -Guidance for characterization and assessment of homogeneity and stability.<br />

45. ISO/REMCO (2005), Committee on reference materials, pp.10.<br />

46. John G.Dorsey, William T.Cooper, et al. (1998), "Liquid Chromatography:<br />

Theory and Methodology", Analytical chemistry, pp.591-644.<br />

47. Jouyban1 Abolghasem, Kenndler Ernst (2008), "Impurity analysis of<br />

pharmaceuticals using capillary electromigration methods", electrophoresis, 29(17),<br />

pp.3531-3551.<br />

48. Kang Ma, Haifeng Wang, et al. (2009), "Purity determination and uncertainty<br />

evaluation of theophylline by mass balance method, high performance liquid<br />

chromatography and differential scanning calorimetry", Analytica Chimica Acta,<br />

650(2), pp.227-233.<br />

49. Kestens V., Zeleny R., et al. (2011), "Differential scanning calorimetry method<br />

for purity determination: A case study on polycyclic aromatic hydrocarbons and<br />

chloramphenicol", Thermochimica Acta, 524, pp.1-6.<br />

50. Kishore Kumar Hotha, Satti Phani Kumar Reddy, et al. (2013), "Forced<br />

degradation studies: practical approach-overview of regulatory guidance and literature<br />

for the drug products and drug substances", International research journal of pharmacy,<br />

4(5), pp.78-84.<br />

51. LGC Standards (2014), Pharmaceutical impurities and <strong>primary</strong> reference<br />

<strong>standard</strong>s 2014, pp.1/10-10/10.<br />

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

52. Li Y.M., Schepdael A. Van, et al. (1998), "Development and validation of<br />

amoxicillin determination by micellar electrokinetic capillary chromatography",<br />

Journal of Chromatography A, 812(1-2), pp.227-236.<br />

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