Development and Certification of the H-form of low Molecular weight Heparin Standard sample

This study was devoted to the development, certification and study of the shelf life of a new certified reference material (CRM) of low molecular weight heparin in H-form (Nad-H), which is intended for chromatographic analysis of a intermediate product at the ion exchange stage of the technology for obtaining calcium nadroparin by the HPSEC-RI method. The certified value of the Nad-H content was determined according to the principle of ISO 17034:2016 and ISO guide 35:2017 – mass balance approach. Was shown the stability of solutions of the standard sample at storage temperatures -40 and -20 °C for 6 months, during this period the recorded decrease in molecular weight does not exceed 5%. These conditions were recommended for storing Nad-H CRM. It had also been found that rapid degradation of Nad-H occurs in solution at room temperature. During the first two days, the molecular weight decreases by 10%. The same significant change was observed after 60 days at temperatures below 8 °C.