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. 2022 Apr 26;17(4):e0264518. doi: 10.1371/journal.pone.0264518

Table 3. Comparative stability profile of liposomal suspension and freeze-dried form of CL13 formulation as per ICH guidelines.

Test Specification Sample Name Initial 25 ± 2°C/ 60 ± 5% RH 5 ± 3°C
Time (months)
1 2 3 6 1 2 3 6
Assay (%w/w) 95 to 105% CL13 suspension 99.52±0.42 98.88±0.31 97.73±0.26 96.67±0.37 94.69±0.51 98.73±0.43 98.33±0.39 97.92±0.34 95.85±0.43
CL13 freeze-dried product 99.71±0.38 99.04±0.17 98.56±0.31 97.96±0.29 96.75±0.45 99.52±0.33 99.41±0.28 99.18±0.19 98.36±0.37

Data expressed as mean ± SD, n = 3