Stability requirements changes

The actual stability requirement for the nonisothermal CSTR system is a little more complex than Eq. (11.43) because the concentration C does change. 

Filing documentation required—Changes being effected should be identihed in a supplement. Long-term stability data are reported in the annual report. 

S is the overlap integral for the atomic orbitals y ua and (piss, at the intemu-clear distance of 74 pm. As we have seen in Section 4.3 for H2", the interpretation of bond stabilization requires consideration of changes in both the electronic potential and kinetic energy, and atomic orbital contraction plays an important role (ref. 39). This role is simulated by assuming a larger effective nuclear charge in the mathematical expressions of isa and isb (see Table 3.1 and expression 5.38). 

For new excipients that are not listed in a compendia there may be a need to generate stability data even though there is no formal stability requirement. New excipients need to be handled on a case-by-case basis. An excipient that is a physical modification of a compendial item but does not meet all of the compendial tests is a case for which stability data would not be needed. An example could be a component that has been physically modified (e.g., milled), but not chemically changed, or an excipient that is a mixture of compendial items to form a new excipient. These typically should not require generation of a stability database. 

NOE experiments typically require significant spectrometer time because the enhancements being sought are rather small. The NOE difference experiment represents a stringent test of both short- and long-term spectrometer stability, since changes in rf phase or frequency or in magnetic field contribute to... 

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