CTAB and DOC are used as reagents in the purification of Hib polysaccharide. Polysaccharide is purified by precipitation with CTAB from fermented broth followed by solvent extraction and DOC is used to remove the protein impurities. The reagents used in the purification process should be removed from the product as per regulatory requirements. These two residual reagents can be easily identified and quantified in purified Haemophilus influenzae type b polysaccharide by NMR. The LOD of these residual reagents is 0.1% (10 μg/mL) and LOQ is 0.5% (50 μg/mL) with respect to polysaccharide determined from the spectrum. The absence of the peaks corresponding to CTAB and DOC in the NMR spectrum of purified polysaccharide confirms either they are absent or present at less than 0.1%. The present study provides supporting data from the regulatory viewpoint, which can help in circumventing the time-consuming studies for the vaccine manufacturers to develop different analytical methods for identification and quantification of CTAB and DOC as per regulatory requirements.

CTAB 和 DOC 用作纯化 Hib 多糖的试剂。多糖通过用 CTAB 从发酵肉汤中沉淀然后进行溶剂萃取来纯化，并使用 DOC 去除蛋白质杂质。纯化过程中使用的试剂应按照法规要求从产品中去除。这两种残留试剂可以在纯化的流感嗜血杆菌中轻松识别和定量b型多糖的核磁共振。这些残留试剂的 LOD 为 0.1% (10 μg/mL)，LOQ 为 0.5% (50 μg/mL)，相对于从光谱中确定的多糖而言。在纯化多糖的 NMR 谱中没有对应于 CTAB 和 DOC 的峰证实它们不存在或以低于 0.1% 的量存在。本研究提供了监管角度的支持数据，有助于疫苗制造商避免耗时的研究，以根据监管要求开发不同的分析方法来识别和量化 CTAB 和 DOC。