Determination of amylose/particulate relationship in hydroxyethylstarch.
Visual particulate was observed to form in parenteral hydroxyethylstarch over 24 months during stability studies. The particulate was identified as being amylose using FT-IR microscopy. Amylose values were measured in the bulk drug using the starch-iodine reaction. The amylose numbers measured in the bulk drug were found to correlate well with the measured particulate values in the parenteral formulation.
Stephens
D
D
Abbott Laboratories, Hospital Products Division, Abbott Park, IL 60064-3500, USA.
Bares
D
D
Robinson
D
D
Pec
E
E
D000688:Amylose / Q000737:chemistry*; D004355:Drug Stability; D006895:Hydroxyethyl Starch Derivatives / Q000737:chemistry*; D010316:Particle Size; D010952:Plasma Substitutes / Q000737:chemistry*
D006895:Hydroxyethyl Starch Derivatives; D010952:Plasma Substitutes; D000688:Amylose