An improved freeze-dried bilirubin preparation.
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.
D000818:Animals; D001663:Bilirubin / Q000592:standards*; D002417:Cattle; D004121:Dimethyl Sulfoxide; D004355:Drug Stability; D004356:Drug Storage; D005612:Freeze Drying; D006801:Humans; D012709:Serum Albumin; D013696:Temperature
D012709:Serum Albumin; D001663:Bilirubin; D004121:Dimethyl Sulfoxide