Monitoring the purity of pharmaceutical heparin preparations by high-field 1H-nuclear magnetic resonance spectroscopy.

Abstract:

:High-field (300 MHz) 1H NMR spectral analyses are reported for various sodium or calcium heparin products available on the Canadian market. Dermatan sulfate (chondroitin sulfate B) was detected as a contaminant in virtually all of these products. Its content varied among the suppliers from less than 1 to 15%, and also over nearly the same range within the groups of heparin preparations of particular suppliers. No correlation was found between in vitro biological activities (potency and anti-factor Xa by the USP tests) and the levels of dermatan sulfate found. Other components, or unlisted constituents, detected in some preparations were paramagnetic metal ions, polyols, and lidocaine.

journal_name

J Pharm Sci

authors

Neville GA,Mori F,Holme KR,Perlin AS

doi

10.1002/jps.2600780205

subject

Has Abstract

pub_date

1989-02-01 00:00:00

pages

101-4

issue

2

eissn

0022-3549

issn

1520-6017

pii

S0022-3549(15)47910-9

journal_volume

78

pub_type

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