An improved freeze-dried bilirubin preparation
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Abstract:
We describe the conditions for successful freeze-drying of bilirubin solutions in the presence of dimethylsulfoxide and human serum albumin. Freeze-dried bilirubin preparations rehydrate readily, rapidly resulting in clear solutions. The preparations exhibit excellent homogeneity and stability at -20 degrees C. Accelerated storage tests indicate that the freeze-dried product would also be stable at higher temperatures but our results do not permit, at the present time, to make accurate predictions regarding the stability at 4 degrees C or 0 degrees C. We believe that our approach will permit manufacturers of bilirubin calibrators for clinical use to improve the quality of their products.
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