Background: Aluminum (Al) is classified as other elements by ICH, and its permitted daily exposure (PDE) has not been established. As it might cause compromised renal function, guidelines, regional regulations and practices need to be addressed. According to the United States Pharmacopeia 41 and the Japanese Pharmacopoeia 17, the aluminum content of large-volume parenterals (LVPs) used in total parenteral nutrition (TPN) therapy must not exceed 25 ng mL^-1. Therefore, the package insert of LVPs used in TPN therapy must state the content of aluminum.

Objective: A new microwave assisted acid digestion pretreatment together with inductively coupled plasma mass spectrometry (ICP-MS) method was developed for the determination of aluminum content in Dextran 40 Glucose Injection. The method was successfully applied for quality evaluation of commercial Dextran 40 Glucose Injection.

Methods: Samples were digested by a mixture of nitric acid and hydrochloric acid, with the assistance of microwave. After that, ICP-MS in KED mode was employed to analyze the samples.

Results: The method showed a good linearity (r²=0.9999) within the range of 2~100 ng mL^-1, with the limit of detection and quantitation of 0.482 ng mL^-1 and 1.61 ng mL^-1, respectively. A good precision was obtained with relative standard deviation (RSD) of 8.8% (n=6). The spike recoveries with low, middle and high Al content in 9 sample were 102.2%~107.4%.

Conclusion: The developed method was successfully applied for the analysis of Al content in 44 batches of Dextran 40 Glucose Injection produced by 9 pharmaceutical companies from domestic or international enterprises. The Al content of Dextran 40 Glucose Injection varied greatly between different enterprises or different batches. Meanwhile, among total of 44 batches, the Al content in 3 batches of Dextran 40 Glucose Injection exceeded the limitation of 25 ng mL^-1, which might cause potential safety problems.

背景：铝 (Al) 被 ICH 归类为其他元素，其每日允许暴露量 (PDE) 尚未确定。由于它可能会导致肾功能受损，因此需要解决指南、地区法规和实践问题。根据美国药典 41 和日本药典 17，全胃肠外营养 (TPN) 治疗中使用的大容量注射剂 (LVP) 的铝含量不得超过 25 ng mL ^-1。因此，用于 TPN 治疗的 LVP 的说明书必须说明铝的含量。

目的：开发了一种微波辅助酸消解预处理结合电感耦合等离子体质谱 (ICP-MS) 的新方法，用于测定葡聚糖 40 葡萄糖注射液中的铝含量。该方法已成功应用于商品化葡聚糖40葡萄糖注射液的质量评价。

方法：在微波辅助下，用硝酸和盐酸混合溶液消解样品。之后，采用 KED 模式的 ICP-MS 分析样品。

结果：该方法在2~100 ng mL ^-1范围内线性良好（r ² =0.9999），检出限和定量限分别为0.482 ng mL ^-1和1.61 ng mL ^-1。获得了良好的精密度，相对标准偏差 (RSD) 为 8.8% (n=6)。9个样品中低、中、高Al含量的加标回收率为102.2%~107.4%。

结论：该方法成功应用于国内外9家药企生产的44批次葡聚糖40葡萄糖注射液中铝含量的分析。不同企业或不同批次的葡聚糖40葡萄糖注射液Al含量差异较大。同时，在44批次中，有3批次葡聚糖40葡萄糖注射液的Al含量超过了25 ng mL ^-1的限值，可能存在安全隐患。