Merck 製藥原料
Sucrose Emprove® Expert極低内毒毒素,低奈米顆粒雜質
Sucrose Emprove ® Essential 低内毒素
Emprove® Expert核心優勢
低奈米顆粒雜質、生物負載以及極低內毒素含量 (50.3 IU/g)
符合ChP、EP、JEP、NF 多國藥典
高度一致的批間穩定性
支援高風險製劑應用
Emprove dossiers 文件幫助遵守法規要求
奈米顆粒雜質(NPI)
Standard Sucrose vs. Emprove@ Expert
蔗糖原材料中含有100-200nm的奈米顆粒雜質(NPI), 對於最終製劑會造成一定的風險:
干擾聚體分析
影響製劑穩定性
通過純化製程設計明顯降低奈米顆粒粒雜質含量
Emprove® Expert 明顯降低 NPIs 含量(Fig.1a)
Emprove® Expert 展現高度穩定的批次間一致性(Fig.1b)
Figure 1: Levels of nanoparticulate impurities were compared between standandard pharmaceutical grade sucrose and highly purified sucrose Emprove Expert. (a) Size distribution of nanoparticles present in sucrose was determined by dynamic light scattering. The nanoparticle peak (size range 100-1000 nm) was absent in the case of the purified sucrose (Emprove Expert). (b) Concentration of nanoparticles present in sucrose (particles/g sucrose) was measured by nanoparticle tracking analysis. The concentration in 4 different batches of sucrose Emprove Expert was significantly lower than the standard sucrose grade and close to the detection limit of the method. For all measurements, 10% sucrose solutions (w/w) were prepared in Milli-Q@ water and filtered through a 0.22-um PVDF membrane before analysis.
訂購資訊
