Paskiet D M
Monarch Analytical Laboratories Incorporated, Maumee, Ohio, USA.
PDA J Pharm Sci Technol. 1997 Nov-Dec;51(6):248-51.
The migration of substances from rubber packaging materials into drug products can be significant with certain packaging materials in contact with organic solvent systems. Recommendations for testing drug products for leachables are continually evolving to address new developments. Testing packaging materials using simulated solvents is not always an acceptable protocol for the pharmaceutical industry. We describe a rational strategy for evaluation of the drug product for packaging extractables. A profile of the extractables from rubber packaging materials was made with a range of organic solvents and stress conditions to provide information on substances to target in the drug product. The drug product was evaluated to determine if the matrix would cause interferences that might inhibit detection of the found extractables. Analytical methods were selected based on these findings. The procedures were validated according to FDA guidelines. A stability program using time and storage conditions as variables provided information for acceptance criteria. This same strategy can be used on other types of pharmaceuticals and packaging materials.
对于某些与有机溶剂系统接触的包装材料而言，物质从橡胶包装材料迁移至药品中的情况可能很显著。针对药品浸出物检测的建议在不断发展，以应对新的进展。使用模拟溶剂检测包装材料对制药行业来说并不总是可接受的方案。我们描述了一种评估药品中包装可提取物的合理策略。利用一系列有机溶剂和应力条件绘制了橡胶包装材料可提取物的图谱，以提供药品中目标物质的相关信息。对药品进行评估，以确定其基质是否会产生干扰，从而可能抑制对所发现可提取物的检测。基于这些发现选择了分析方法。按照美国食品药品监督管理局（FDA）的指导方针验证了相关程序。以时间和储存条件作为变量的稳定性研究提供了验收标准的相关信息。同样的策略可用于其他类型的药品和包装材料。
