Considerations for the national specifications for low molecular weight heparin drugs
YANG Xi
ZHOU Yi
LI Hui-yi
Abstract：The specifications of dalteparin sodium,nadroparin calcium,enoxaparin sodium as well as their injections were going to be included as new varieties in Pharmacopoeia of the People's Republic of China(2025).This article introduced the main inspection items,analyzing methods,and limits of these specifications,and focused on the considerations for molecular weight and molecular weight distribution,anti-X a factor activity and anti-Ⅱ a factor activity,process impurities and degradation impurities,as well as structure-related identification,providing a reference for pharmaceuticals to understand and implement the standards well.
Keywords：low molecular weight heparindalteparin sodiumnadroparin calciumenoxaparin sodiumnational specification
Publication Date：2025-09-30
Online Publishing Date：2026-08-14(First online date of this platform, not the publication date of the document)
Pages：5( 1931-1935 )