Abstract
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.
Footnotes
- Received September 12, 1998.
- Accepted April 2, 1999.
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