This expectation has been confirmed in practice. When albumin was heated for 10 hours at 60 deg. Numerous biological effects of caprylate have been reported. In view of this broad range of demonstrated effects, it is difficult to predict the outcome of increased caprylate infusion in different patients and different clinical settings. For this reason, the agency believes that the ratio of caprylate to protein should not be increased above that necessary to stabilize albumin.
Many factors contribute to the stability of albumin during heating.
Therefore, conditions can be chosen to maximize the stability of albumin without increasing the quantity of caprylate above that specified in the proposed rule. C. Proposed Sec. The proposed change to Sec. One comment on proposed Sec. The comment recommended that the first sentence be amended with definitions to provide increased clarity.