49
Figure 2: Overlay of zinc stearate isotherms
For the calcium stearate, the sample amount in the sample cells was 1.05 g and 1.25 g, which is approximately 6 m2 least 2 m2
of material for surface area evaluation). Reproducibility was calculated at
0.18 %. Analysis time averaged approximately 36.5 minutes for two simultaneous stations collecting fi ve points each under ‘Helium Measure Void Volume’.
Table 2: Calcium stearate BET SSA results Sample
Sample 1 run1 Sample 1 run 2 Sample 1 run 3 Sample 2 run1 Sample 2 run 2 Sample 2 run 3 Average
6.264 6.262 6.289 6.287 6.278 6.279
6.2765
Standard deviation 0.011327 Reproducibility
0.18 % Summary
For the zinc stearate, the sample amount in the sample cells was 0.53 g and 0.55 g, which is approximately 2.7 m2
of total area in the cell. Reproducibility was calculated at 0.41%. Analysis time averaged 34 minutes for two simultaneous fi ve-point isotherms.
Data were collected and processed using Kaomi for Nova 21 CFR Part 11 software (optional for industries requiring data integrity and full audit trail). The report (Figure 3) is customisable so a user can select specifi c graphs, tables, or a summary of results. Here, a template from the software specifi cally for BET analysis was used.
Table 3: Zinc stearate BET SSA results. Sample
Sample 1, run 1 Sample 1, run 2 Sample 1, run 3 Sample 2, run 1 Sample 2, run 2 Sample 2, run 3 Average
5.061 5.071 5.047 5.092 5.094 5.098 5.077
Standard deviation 0.020721 Reproducibility
0.41 %
Great reproducibility of surface area measurement results can be achieved with the Nova 600 when there is enough material in the sample cell for smooth data with minimal noise. Contributions to reproducibility may also come from sample homogeneity. In this study, only two aliquots of each stearate were prepared. However, based on the reproducibility percentage (well under 0.5%) the material is likely to be homogeneous. The results align with the instrument specifi cation of better than 2% reproducibility.
BET SSA (m2/g) Correlation coeffi cient
0.99962 0.9997
0.99967 0.99979 0.99954 0.99981
C constant
27.3836 27.7068 27.3735 27.2475 27.133
27.0874
The instrument’s built-in capability to provide CFR compliance enables a user to submit data for revision and for a supervisor to review and approve the reports (refer to Figure 3) using the two-step signature feature. Also, each report includes the relevant audit trail to the specifi c analysis (different from the full audit trail) for pre- and post-analysis operations. Date- and time-stamps for each operation performed, together with operator, demonstrate compliance with CFR Part 11.
References
1. Goldstab Organics Pvt. Ltd. Metallic Stearates: Harnessing The Benefi ts And A Key To Effi ciency. [Online] [Cited: Jan 14, 2025.]
https://www.goldstab.com/articles/metallic-stearatesharnessing-the-benefi ts-and-a- key-to-effi ciency.
2. MarketsandMarkets Research Pvt Ltd. Metallic. Stearates Market by Type (Magnesium Stearates, Zinc. Stearates, Calcium Stearates), End-Use Industry (Polymer & Rubber, Pharmaceuticals & Cosmetics, Building and Construction), & Region (APAC, North America, Europe, RoW) - Global Forecast to 2028. Markets and Markets. [Online] Oct 20, 2024. [Cited: Jan 14, 2025.]
https://www.marketsandmarkets.com/MarketReports/
metallic-stearates-market-157185802.html.
3. United States Food and Drug Administration. Part 11, Electronic Records; Electronic Signatures - Scope and Application - Guidance for Industry. Regulatory Information. [Online] Sept 2003. [Cited: Jan 15, 2025.]
https://www.fda.gov/regulatory-information/search-fdaguidance-documents/part-11-electronic- recordselectronic-signatures-scope-and-application.
Figure 3: Results report generated with Kaomi for Nova 21 CFR Part 11 software of total area in the cell (well over our recommendation of at
BET SSA (m2/g) Correlation coeffi cient
0.99899 0.99908 0.99940 0.99926 0.99932 0.99917
C constant
17.5997 17.5105 17.4071 17.4003 17.3976 17.7146
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