Author(s):
Sergei V. Krivoshchekov, Denis A. Isakov, Anastasia V. Zykova, Artem M. Guryev
Email(s):
ksv_tsu@mail.ru
DOI:
10.52711/0974-360X.2025.00311 
Address:
Sergei V. Krivoshchekov*, Denis A. Isakov, Anastasia V. Zykova, Artem M. Guryev
Technology Implementation Center, Central Research Laboratory, Siberian State Medical University, 634050, Tomsk, Russia.
*Corresponding Author
Published In:
Volume - 18,
Issue - 5,
Year - 2025
ABSTRACT:
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.
Cite this article:
Sergei V. Krivoshchekov, Denis A. Isakov, Anastasia V. Zykova, Artem M. Guryev. Development and Certification of the H-form of low Molecular weight Heparin Standard sample. Research Journal of Pharmacy and Technology. 2025;18(5):2169-4. doi: 10.52711/0974-360X.2025.00311
Cite(Electronic):
Sergei V. Krivoshchekov, Denis A. Isakov, Anastasia V. Zykova, Artem M. Guryev. Development and Certification of the H-form of low Molecular weight Heparin Standard sample. Research Journal of Pharmacy and Technology. 2025;18(5):2169-4. doi: 10.52711/0974-360X.2025.00311 Available on: https://rjptonline.org/AbstractView.aspx?PID=2025-18-5-34
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