Baylocq D, Majcherczyk C, Pellerin F
Ann Pharm Fr. 1989;47(4):196-204.
The use of plastic materials as containers for pharmaceuticals implies the knowledge of previous data and the constancy of their composition. These data and migration studies are acquired in the development phase and are the ground line in routine control. The molecular size distribution and the identification of principal additives are determined by gel permeation chromatography. Infra red spectrometry is applied to the determination of relative proportions of monomers in copolymers; HPLC and GLG head space are suitable for the identification of additives and for the studies of stability.
使用塑料材料作为药物容器意味着需要了解先前的数据及其成分的稳定性。这些数据和迁移研究是在研发阶段获得的，也是常规控制的基线。通过凝胶渗透色谱法测定分子大小分布和主要添加剂的鉴定。红外光谱法用于测定共聚物中单体的相对比例；高效液相色谱法和顶空气相色谱法适用于添加剂的鉴定和稳定性研究。
