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. 2020 Jul 30;2:100053. doi: 10.1016/j.ijpx.2020.100053

Table 1.

Long term stability data according to ICH Q5C guidelines for biotechnological products. Content values are expressed as mean ± SD.

Property 0 months 3 months 6 months 12 months
1. Particle Size 297.3 nm 296.5 nm 296.1 nm 293.6 nm
2. Quillaja Saponin content 103.49 ± 0.26 μg 97.22 ± 0.52 μg 101.53 ± 0.87 μg 95.45 ± 0.25 μg
3. LPS content 57.03 ± 1.52 μg 58.67 ± 1.14 μg 52.87 ± 2.05 μg 56.33 ± 4.06 μg