02-15-2018 05:10 PM
Yes, containers are integral in determining chemical stability. Per USP Chapter <797>.
Determining Beyond-Use Dates
BUDs and expiration dates are not the same (see General Notices and Requirements). Expiration dates for the chemical and physical stability of manufactured sterile products are determined from results of rigorous analytical and performance testing, and they are specific for a particular formulation in its container and at stated exposure conditions of illumination and temperature. When CSPs deviate from conditions in the approved labeling of manufactured products contained in CSPs, compounding personnel may consult the manufacturer of particular products for advice on assigning BUDs based on chemical and physical stability parameters. BUDs for CSPs that are prepared strictly in accordance with manufacturers' product labeling shall be those specified in that labeling or from appropriate literature sources or direct testing.
When assigning a beyond-use date, compounding personnel should consult and apply drug-specific and general stability documentation and literature where available, and they should consider the nature of the drug and its degradation mechanism, the container in which it is packaged, the expected storage conditions, and the intended duration of therapy (see Expiration Date and Beyond-Use Date under Labeling in the General Notices and Requirements).
02-15-2018 05:16 PM
I understand the container is important to stability. Maybe, I need to ask the question differently. Does the container count as a component when determining where a CSP is low or medium risk?