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 th...

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Bibliographic Details
Published inPDA journal of pharmaceutical science and technology Vol. 53; no. 4; p. 181
Main Authors Stephens, D, Bares, D, Robinson, D, Pec, E
Format Journal Article
LanguageEnglish
Published United States 01.07.1999
Subjects
Amylose - chemistry
Drug Stability
Hydroxyethyl Starch Derivatives - chemistry
Particle Size
Plasma Substitutes - chemistry
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Summary: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.
ISSN:1079-7440