Place of DSC purity analysis in pharmaceutical development

Giron, D.; Goldbronn, C.

doi:10.1007/bf02547150

Cited by 56 publications

(21 citation statements)

References 15 publications

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“…Above this temperature, the solid phase only consists of a pure substance. As the temperature decreases with the formation of the eutectic phase of impurities (Figure 1), the molar fraction of impurities in liquid phase x 2 is constantly diminished since the pure substance dissolves in eutectic solution within this temperature range (Giron, Goldbronn, 1995;Staub, Perron, 1974). This is expressed by Equation 2:…”

Section: Introductionmentioning

confidence: 99%

Determination of the melting temperature, heat of fusion, and purity analysis of different samples of zidovudine (AZT) using DSC

Araújo

Bezerra

Storpirtis

et al. 2010

Braz. J. Pharm. Sci.

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The determination of chemical purity, melting range, and variation of enthalpy in the process of characterizing medicines is one of the principal requirements evaluated in quality control of the pharmaceutical industry. In this study, the method of purity determination using DSC was outlined, as well as the application of this technique for the evaluation of commercial samples of zidovudine (AZT) (raw material) supplied by different laboratories. To this end, samples from six different laboratories (A, B, C, D, E, and F) and the standard reference (R) from the United States Pharmacopeia (USP) were analyzed. The DSC curves were obtained in the temperature range of 25 to 200 o C under the dynamic atmosphere of N 2 (50 mL min , using an Al capsule containing approximately 2 mg of sample material. The results demonstrated that the standard reference presented a proportion of 99.83% whereas the AZT samples presented a variation ranging from 97.59 to 99.54%. In addition, the standard reference was found to present a temperature of onset of melting point of 122.80 °C. Regarding the samples of active agents provided by the different laboratories, a variation ranging from 118.70 to 122.87 °C was measured. In terms of DH m , the samples presented an average value of 31.12 kJ mol -1.Uniterms: Zidovudine/purity determination. Differential scanning calorimetry. Thermal analysis. Medicines/quality control. Medicines/qualitative analysis.A determinação da pureza química, a faixa de fusão e a variação de entalpia envolvida no processo de caracterização de fármacos é um dos principais requisitos avaliados no controle de qualidade em indústrias farmacêuticas. Neste trabalho é feita uma breve abordagem sobre o método de determinação de pureza utilizando DSC, assim como a aplicação desta técnica para avaliação de amostras comerciais de zidovudina (AZT) (matéria-prima) fornecida por diferentes laboratórios. Para tal, foram analisadas amostras de seis diferentes laboratórios (A,B,C,D,E e F) e a substância química de referência (R) da United States Pharmacopeia (USP). As curvas DSC foram obtidas na faixa de temperatura entre 25 a 200 o C, sob atmosfera dinâmica de N 2 (50 mL min -1 ), b=2 o C min -1 , utilizando cápsula de Al contendo aproximadamente 2 mg de amostra. De acordo com os resultados, pode-se observar que a substância química de referência apresentou teor igual a 99,83% e que as amostras de AZT apresentaram uma faixa de variação entre 97,59 e 99,54%. Pode-se verificar, ainda, que a substância química de referência apresentou uma temperatura onset de fusão igual a 122,80 °C. Para as amostras dos princípios ativos fornecidos pelos diferentes laboratórios, pode-se verificar uma faixa de variação entre 118,70 e 122,87 °C. No que se refere ao DH m , as amostras apresentaram valor médio de 31,12 kJ.mol -1 .Unitermos: Zidovudina/determinação da pureza. Calorimetria exploratória diferencial. Análise térmica. Medicamentos/controle de qualidade. Medicamentos/análise qualitativa.

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Section: Introductionmentioning

confidence: 99%

Determination of the melting temperature, heat of fusion, and purity analysis of different samples of zidovudine (AZT) using DSC

Araújo

Bezerra

Storpirtis

et al. 2010

Braz. J. Pharm. Sci.

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“…Therefore thermal analysis is a common part of characterizing compounds with biological activity [20,21,22,23,24,25]. Thermoanalytical methods provide important information on the thermal stability, polymorphic forms or structural changes [26,27,28], and purity of potential new drugs [29,30,31,32]. In continuation of our earlier work on synthesis, physical and chemical characterization of iron(II) complexes with amine ligands [33] in this paper Pt(II) coordination compounds with different amine ligands are described.…”

Section: Introductionmentioning

confidence: 94%

Synthesis, physico-chemical characterization and bacteriostatic study of Pt complexes with substituted amine ligands

Holló

Szilágyi

Várhelyi

et al. 2016

J Therm Anal Calorim

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Three complexes of general formula PtCl 2 R 2 were synthesized, where R is the amine ligand with aromatic substituents. Coordination compounds [Pt(an) 2 Cl 2 ] (1), [Pt(pa) 2 Cl 2 ] (2) and [Pt(aph) 2 Cl 2 ] (3), where an is 2-aminonaphtalene, pa is 2-pyrimidinamine and aph is 4-anilinophenol, were characterized by on-line coupled TG/DTA-MS, powder XRD and spectroscopic techniques (FTIR, ESI-MS and NMR), and tested against selected Gram(+) and Gram(-) bacteria. The thermal data show that all three compounds contain lattice or absorbed water, and the stability of the anhydrous compounds in nitrogen decreases in the order 2 > 1 > 3. Above 200 °C, the complexes loose characteristic fragments of their ligands. The spectroscopic data are in accordance with the thermal properties of the samples and prove their composition. The compounds are more effective inhibitors of Gram(+) than Gram(−) bacteria.

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“…© Farm Pol, 2019, 75 (11): 633-637 farmaceutycznych, w tym w ocenie ich czystości i w badaniu form polimorficznych [5][6][7]. Dane zestawione w tabeli 1 wskazują, że metody analizy termicznej są coraz częściej stosowane jako techniki wspomagające preformulację stałych postaci leku, przyczyniając się wydatnie do opracowania postaci leku o odpowiedniej jakości, skutecznej w działaniu i trwałej podczas długotrwałego przechowywania.…”

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Thermomechanical analysis and thermal dielectric analysis in pharmacy

Szynkaruk¹,

Wesołowski²

2019

Farm Pol.

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Tom 75 • nr 11 • 2019 jakim podlegają substancje stosowane do celów farmaceutycznych, tj. aktywne składniki farmaceutyczne (ang. active pharmaceutical ingredients, APIs), substancje pomocnicze, półprodukty i gotowe produkty farmaceutyczne [1-7]. Najważniejsze procesy, jakie z punktu widzenia farmacji mogą być badane tymi technikami, to przemiany fazowe-przemiana szklista, topnienie, krystalizacja, parowanie, sublimacja, dehydratacja i hydratacja, solwatacja i desolwatacja, polimorfizm i pseudopolimorfizm, a ponadto, reakcje M etody analizy termicznej, w szczególności różnicowa analiza termiczna (ang. Differential thermal analysis, DTA), różnicowa kalorymetria skaningowa (ang. differential scanning calorimetry, DSC) i analiza termograwimetryczna (ang. thermogravimetric analysis, TGA), są nowoczesnymi, skomputeryzowanymi i zautomatyzowanymi technikami analizy instrumentalnej, które umożliwiają badanie w różnych warunkach tem

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Place of DSC purity analysis in pharmaceutical development

Cited by 56 publications

References 15 publications

Determination of the melting temperature, heat of fusion, and purity analysis of different samples of zidovudine (AZT) using DSC

Determination of the melting temperature, heat of fusion, and purity analysis of different samples of zidovudine (AZT) using DSC

Synthesis, physico-chemical characterization and bacteriostatic study of Pt complexes with substituted amine ligands

Thermomechanical analysis and thermal dielectric analysis in pharmacy

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