供应商资格中的热分析和FTIR:与处理相关的杂质和风险的证据
Áquila Priscilla Ferreira de Mendonça1, Alana Mara Calou de Araújo1, Linaldo Francisco da Silva Filho1
1Federal University of Pernambuco (UFPE), Prof. Artur de Sá Avenue, s/n, University City, Recife PE, 50740-525, Brazil.
Journal of pharmaceutical sciences
|June 17, 2025
概括
供应商资格和原材料测试对于复合药房至关重要. 这项研究发现了帕帕因中的杂质,强调需要严格的物理化学控制来确保药品的安全性和有效性.
科学领域:
- 制药科学 制药科学
- 分析化学 分析化学
- 材料科学 是一种材料科学.
背景情况:
- 主制配方需要定制剂量,使原材料质量对药品的有效性和安全性至关重要.
- 供应商资格是必不可少的,然而,尽管有法规,污染等偏差仍可能发生.
研究的目的:
- 分析供应商资格认证流程,并强调原材料特征测试的重要性.
- 为了评估常用的复合药房原材料的纯度和结构完整性.
主要方法:
- 不同扫描热量计 (DSC)
- 热重力测量分析 (TGA)
- 里埃变换红外光谱法 (FTIR) 是一种
主要成果:
- 在帕帕因样本中检测到杂质和结构变化.
- 氨酸,可纳和氨酸样本显示出足够的纯度.
- 鉴定发现不同供应商的原材料质量存在差异.
结论:
- 活性药物成分的物理化学控制对于复合药房至关重要.
- 确保原材料的纯度可以保障复合药物的安全性和有效性.
- 严格的供应商资格和材料测试对于患者健康至关重要.
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