Molecular Weights of Bovine and Porcine Heparin Samples: Comparison of Chromatographic Methods and Results of a Collaborative Survey

Abstract

In a collaborative study involving six laboratories in the USA, Europe, and India the molecular weight distributions of a panel of heparin sodium samples were determined, in order to compare heparin sodium of bovine intestinal origin with that of bovine lung and porcine intestinal origin. Porcine samples met the current criteria as laid out in the USP Heparin Sodium monograph. Bovine lung heparin samples had consistently lower average molecular weights. Bovine intestinal heparin was variable in molecular weight; some samples fell below the USP limits, some fell within these limits and others fell above the upper limits. These data will inform the establishment of pharmacopeial acceptance criteria for heparin sodium derived from bovine intestinal mucosa. The method for MW determination as described in the USP monograph uses a single, broad standard calibrant to characterize the chromatographic profile of heparin sodium on high-resolution silica-based GPC columns. These columns may be short-lived in some laboratories. Using the panel of samples described above, methods based on the use of robust polymer-based columns have been developed. In addition to the use of the USP’s broad standard calibrant for heparin sodium with these columns, a set of conditions have been devised that allow light-scattering detected molecular weight characterization of heparin sodium, giving results that agree well with the monograph method. These findings may facilitate the validation of variant chromatographic methods with some practical advantages over the USP monograph method.

Converting the Distinct Heparins Sourced from Bovine or Porcine Mucosa into a Single Anticoagulant Drug

“…[4][5][6][7] Improvements in analytical approaches for evaluation of heparins (e.g. two-dimensional [2D] nuclear magnetic resonance [NMR] and anti-FIIa and -FXa chromogenic assays) have demonstrated that UFH preparations from distinct animal sources may have different molecular size, disaccharide compositions, anticoagulant/anti-thrombotic potencies and/or homogeneities (mixture of distinct UFH chains), [7][8][9][10][11][12][13][14] as shown in ►Fig. 1A, B and ►Supplementary Fig.…”

Advanced selection materials in solar cell efficiency and their properties - A comprehensive review

“…Therefore, it is the most preferred material for the innovation of light, and thin-film solar cells. These batteries have tape holes that can absorb light more efficiently and increase their efficiency [26]. During the initial assembly of these solar cells, the CdTe -based solar cells are made of polyglass-like materials, and glass is selected as the substrate.…”

Tools for the Quality Control of Pharmaceutical Heparin

“…The underlying structure of heparin is known to be tissue specific and differs between species, with individual animals of the same species exhibiting differences. Such variations are observed throughout the molecular weight populations, disaccharide compositions, and anticoagulant activities (Table 1, Figure 2A) [1,10,13,14,15]…”

“…MW has also been defined using 13 C NMR [101] and MS [102,103] . Size definition when compared to standards is difficult, as standards are hard to define or acquire, meaning that they are usually created in-house, leading to variation between labs, however a USP MW standard is available to try to reduce this [6,14,94]. A triple detector (TDA) approach has also been utilised, where a RALS detector, a differential refractive index detector (SLS detection), and a viscometer are used in concert to accurately define the MW of heparin and may also be used to create uniform standards [104].…”