Establishment of the national pharmaceutical reference standards of polyethylene glycol 4000
Objective:To develop the national pharmaceutical reference standards of polyethylene glycol 4000 for marking the molecular weight and distribution,improving the standard of quality control.Methods:The structure of polyethylene glycol 4000 was confirmed by IR,NMR,MS and other techniques.The moisture content was determined by Karl-Fischer titration method.The ignition residue was investigated by TGA method,and the hygroscopicity was investigated by DVS method.To screen the raw materials,the HPLC-CAD method was established to quickly compare the differences between batches of raw materials.The uniformity and stability of molecular weight were investigated by single-factor analysis of variance and linear fitting method,respectively.The weight-average molecular weight of the characteristic value was determined by the method of collaborative calibration of multiple laboratories.Results:The polyethylene glycol 4000 has good uniformity and stability,and the Mw is 3 798.Conclusion:The reference material for the study of molecular weight and distribution of polyethylene glycol 4000 was developed for the first time.The development strategy of this kind of reference material was clarified and a number of batch work were completed.
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