Authors:J. May, A. Del Grosso, R. Wheeler, and N. Etz
A TA Instruments Thermal Analysis System (TG) has been interfaced to the Hewlett Packard 5972 quadrupole mass spectrometer.
An OSS-2 variable outlet splitter was plumbed between the TG and the mass spectrometer. This interface allows continuous monitoring
of the ion intensities of mass peaksm/e=18 (water) andm/e=44 (carbon dioxide) used to elucidate the TG transitions attributable to residual moisture in freeze-dried biological products.
Moisture specifications must be met in order to insure product stability throughout the approved shelf life. TG/MS results
are discussed for BCG Vaccine, BCG Live (Intravesical) and U. S. Standard Antihemophilic Factor. Karl Fischer and TG/MS moisture
results are compared.
Authors:J May, A Del Grosso, N Etz, R Wheeler, and L Rey
(TG), thermogravimetry/mass spectrometry (TG/MS), and loss-on-drying methodology
are used to provide residual moisture results for freeze-dried biological
products regulated by the US Food and Drug Administration. Residual moisture
specifications must be met in order to ensure freeze-dried biological product
potency and stability throughout the licensed product's shelf life.
TG, TG/MS, loss-on-drying and vapor pressure moisture measurements are compared
for a BCG Vaccine. Comparisons are made between residual moisture data for
the freeze-dried cake and vapor pressure moisture determinations in the space
above the freeze-dried cake in the final container. Vapor pressure moisture
precision data is presented for α-interferon and BCG vaccine. Impact
of residual moisture and vapor pressure moisture upon product stability is