One-dimensional cellulose acetate plate electrophoresis--a feasible method for analysis of dermatan sulfate and other glycosaminoglycan impurities in pharmaceutical heparin.
A cellulose acetate plate electrophoresis method for analysis of pharmaceutical heparin and its potential glycosaminoglycan impurities, e.g. dermatan sulfate, chondroitin sulfate and oversulfated chondroitin sulfate, is presented. Heparin is chemically degraded by application of nitrous acid and residual glycosaminoglycans are electrophoretically separated thereafter. After staining using Alcian blue 8GS, these glycosaminoglycan impurities can be quantified by means of comparison to a dermatan sulfate standard. Results of a validation study of this analytical method are shown, demonstrating its feasibility for routine use in analytical quality control labs under GMP conditions.
Domanig
Rainer
R
IPC Analytical & Technical Process Support Labs, Sandoz GmbH, Biotechnical Production Plant Schaftenau, Biochemiestrasse 10, 6336 Langkampfen, Austria.
Jöbstl
Wolfgang
W
Gruber
Silvia
S
Freudemann
Thomas
T
D000423:Alcian Blue / Q000032:analysis; D000925:Anticoagulants / Q000032:analysis*; D004396:Coloring Agents / Q000032:analysis; D003871:Dermatan Sulfate / Q000032:analysis* / Q000378:metabolism / Q000592:standards; D004340:Drug Contamination / Q000517:prevention & control; D004588:Electrophoresis, Cellulose Acetate / Q000379:methods*; D005240:Feasibility Studies; D006025:Glycosaminoglycans / Q000032:analysis* / Q000378:metabolism / Q000592:standards; D006493:Heparin / Q000032:analysis*; D011786:Quality Control; D012015:Reference Standards; D012680:Sensitivity and Specificity; D013194:Staining and Labeling / Q000379:methods
D000925:Anticoagulants; D004396:Coloring Agents; D006025:Glycosaminoglycans; D003871:Dermatan Sulfate; D006493:Heparin; D000423:Alcian Blue