Abstract：
The control of somatropin products according to the monographs of the European Pharmacopoeia (Ph. Eur.) requires a system suitability preparation for the test for related proteins by liquid chromatography. A preparation consisting in a mixture of somatropin and desamidosomatropin, such as the Ph. Eur. Somatropin/desamidosomatropin resolution mixture Chemical Reference Substance (CRS), is to be used to ascertain adequate resolution of the chromatographic setup. Due to low stocks, the Biological Standardisation Programme (BSP) of the Council of Europe and the European Union ran a study to establish a new batch of this system suitability CRS. A freeze-dried candidate batch (cCRS2) was produced and tested at the European Directorate for the Quality of Medicines and HealthCare (EDQM, Council of Europe). The resolution between the peaks due to somatropin and desamidosomatropin was 1.7 and the symmetry factor for the somatropin peak was 1.2. The mean percentage area of the desamidosomatropin peak was 14.6 %. These results showed that cCRS2 is suitable for its intended purpose. Based on these data, in May 2020 the Ph. Eur. Commission established the candidate batch as Ph. Eur. Soma-tropin/desamidosomatropin resolution mixture CRS batch 2.
摘要：
根据欧洲药典（Ph。欧尔.)需要通过液相色谱法测试相关蛋白质的系统适用性准备。一种制剂，由生长激素和去氨基瘤霉素的混合物组成，如博士。欧尔.促生长素/去氨基多瘤素拆分混合物化学参考物质（CRS），用于确定色谱设置的足够分辨率。由于库存不足,欧洲委员会和欧盟的生物标准化计划（BSP）进行了一项研究，以建立新一批该系统适用性CRS。在欧洲药品和医疗保健质量管理局（EDQM，欧洲委员会)。由于生长激素和去氨基瘤蛋白引起的峰之间的分辨率为1.7，生长激素峰的对称因子为1.2。去氨基瘤蛋白峰的平均面积百分比为14.6％。这些结果表明cCRS2适用于其预期目的。基于这些数据,2020年5月，Ph。欧尔.委员会将候选批次确定为Ph。欧尔.Soma-tropin/desamidosomabomropin拆分混合物CRS批次2.
