Abstract
The objective of this study is to determine whether a residual moisture analyzer (RMA) can be an acceptable instrument for measuring the residual moisture in lyophilized demineralized bone matrix (DBM). Instruments from two different manufacturers with differing configurations and controls were compared: the Ohaus MB45 and Arizona Instrument MAX4000XL. The effects of various factors such as test temperature, drying profile, end point criteria, lift compensation, chamber configuration, and rehydration on residual moisture (RM) are examined. The performance of the RMAs is based on their ability to reproduce RM results obtained by the current standard gravimetric method. RMAs provide reliable, accurate and reproducible results in a number of industries that rely on the determination of RM. We hypothesize that RMAs are suitable for measuring RM in DBM and provide validation study data with optimized settings for these two instruments. Potentially, such studies will provide justification for allowance of this methodology as an acceptable alternative to the current gravimetric method allowed by American Association of Tissue Banks Standards.
Similar content being viewed by others
Notes
When using a lower weight loss per unit time as the end criterion we would expect an extended test because it requires that the rate of loss be reduced, thus allowing more moisture to vaporize from the sample and increasing the total weight loss and therefore the RM measured by the RMA.
The vial from the control group that had an average RM of 1.04 ± 0.11 % weighed 0.9980 g so its dry weight can be calculated and is 0.9876 g.
Abbreviations
- AATB:
-
American Association of Tissue Banks
- AZI:
-
Arizona Instrument
- DBM:
-
Demineralized bone matrix
- FDA:
-
Food and Drug Administration
- G:
-
Gravimetric
- GMP:
-
Good manufacturing practice
- KF:
-
Karl Fischer titration
- LC:
-
Lift compensation
- NMR:
-
Nuclear magnetic resonance spectrometry
- RM:
-
Residual moisture
- RMA:
-
Residual moisture analyzer
- TG:
-
Thermogravimetic
References
AATB (2008) AATB standards for tissue banking, 12th edn. American Association of Tissue Banks, McLean, VA
Baker P (1955) The micro-determination of residual moisture in freeze-dried biological materials. J Hyg 53(4):426–435
FDA (1990) Guideline for the determination of residual moisture in dried biological products. Docket #89D-0140 (cf research, compiler)
Horowitz W (ed) (2005) Official methods of analysis of AOAC international, 18th edn, revision 1, method 965.08. Water (free) in fertilizers. Association of Official Analytical Chemists International, Gaithersburg
May J, Grim E, Wheeler RM, West J (1982) Determination of residual moisture in freeze-dried viral vaccines: Karl Fischer, gravimetric and thermogravimetric methodologies. J Biol Stand 10(3):249–259
May J, Wheeler R, Del Grosso A (1988) Compositional analysis of drugs and injectable biological products by thermogravimetry. In: Earnest C (ed) American Society for testing and materials special technical publication #997, pp 48–55
Newman H, Baker D, MacKenzie A (2010). Considerations in determining residual moisture levels in demineralized bone matrix. In: 34th annual AATB meeting
Ohaus Corporation (2001) Instruction manual MB45 moisture analyzer. Pine Brook, NJ
Sato T, Iwata H, Takahashi M, Miura T (1993) Heat tolerance of activity toward ectopic bone formation by rabbit bone matrix protein. Ann Chir Gynaecol Suppl 207:37–40
Shimp L (2008) Heat resistance of allograft tissue. Cell Tiss Bank 9(4):259–266
Towns J (1995) Moisture content in proteins: its effects and measurement. J Chromatogr A 705(1):115–127
Acknowledgments
This research was supported by a grant from the Scientific and Technical Affairs Committee of the American Association of Tissue Banks. The Arizona Instrument company provided sample testing and the MAX4000XL for use in this study.
Author information
Authors and Affiliations
Corresponding author
Rights and permissions
About this article
Cite this article
Gage, A.H., MacKenzie, A.P., Baker, D. et al. Considerations in determination of residual moisture in lyophilized demineralized bone matrix: the role of residual moisture analyzers. Cell Tissue Bank 14, 243–253 (2013). https://doi.org/10.1007/s10561-012-9321-5
Received:
Accepted:
Published:
Issue Date:
DOI: https://doi.org/10.1007/s10561-012-9321-5