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.
Thermogravimetry/mass spectrometry is used to identify TG transitions corresponding to loss of residual moisture in freeze-dried biological products with complex TG curves. While TG weight losses were recorded, ion intensities of mass peaksm/e=18 (water) andm/e=44 (carbon dioxide) were monitored continuously for Typhoid Vaccine U.S.P., Meningococcal Polysaccharide Vaccine Groups A and C Combined and Honey Bee Venom Allergenic Extract. MS ion intensities indicated the difference between evolution of residual moisture and moisture associated with product thermal decomposition. Residual moisture values calculated from TG weight losses indicated by mass spectral data agreed with Karl Fischer moisture data.
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
Authors:Mais J. Jebrail, Naila Assem, Jared M. Mudrik, Michael D.M. Dryden, Kaixiang Lin, Andrei K. Yudin, and Aaron R. Wheeler
A microfluidic technique for combinatorial chemical synthesis of peptidomimetics has been developed. The new method is fast, automated and includes an integrated magnetic separation of inorganic catalysts from reaction products. This proof-of-concept study should lead to methods for generating libraries of compounds suitable for screening for bioactivity.