方案摘要
方案下载应用领域 | 制药/生物制药 |
检测样本 | |
检测项目 | |
参考标准 | 假多晶型药物的表征 |
Solvated systems can be studied by techniques such as moisture sorption, thermogravimetric analysis (TGA), differential scanning calorimetry (DSC) and isothermal calorimetry. Although in theory any one of these techniques can provide adequate data on the energy changes associated with solvation or desolvation, in practice isothermal microcalorimetry often provides superior data on pseudo-polymorphs, especially when only small (milligram) samples are available, or when unexpected results are obtained from other thermal techniques. For example, TGA was unable to detect formation of a drug hydrate in the presence of lactose monohydrate since there was no net change in mass associated with exchange of water between the drug substance and the lactose excipient.
A large percentage of pharmaceutical products are formulated as solids due to their ease of manufacture and packaging, and for the convenience of the patient. However, pharmaceutical compounds can often exist in more than one solid state form, including polymorphs and hydrates (pseudo-polymorphs). Since the solid state structure has potentially significant impact on the stability and bioavailability of the final product, it is essential that the solid state energetics of the compound be characterized and understood.
利用微量热技术研究病毒结构与宿主细胞受体结合反应
等温量热法研究水泥水化
等温微量热法研究生物制品长时间稳定性评价
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