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Table 5 Overview of the shelf life and assay stability results

From: Pharmaceutical compounding of orphan active ingredients in Belgium: how community and hospital pharmacists can address the needs of patients with rare diseases

Assay T0 T3_5°C T1_25°C/60%RH T3_25°C/60%RH Shelf life
L-arginine solution 98.7; 98.8 100.3; 99.9a 100.8; 99.9a 98.5; 97.4a 1 week refrigerated (5 °C)
L-carnitine solution 98.6; 100.8 102.7; 102.8 103.5; 102.9 99.3; 99.9 3 months
Chenodesoxycholic acid capsules 96.9; 96.3; 96.6 97.6; 97.6; 97.6 98.9; 99.4; 99.3 101.2; 100.4b 3 months
Primaquine phosphate capsules 105.7; 101.8 98.4; 99.7 95.3; 96.7 95.3; 99.7 3 months
Pyridoxal phosphate capsules 104.9; 104.6 105.5; 101.8 100.3; 100.3 101.2; 100.2 3 months
Sodium benzoate solution 99.0; 99.5 101.8; 101.6 100.2; 100.1 100.6; 97.2 3 months
Sodium perchlorate solution 90.4; 96.18 92.1; 90.1 90.6; 93.2 91.7; 89.12 3 months
Sodium phenylbutyrate solution 99.7; 99.5 99.4; 101.5 100.0; 100.9 96.7; 99.7 3 months
  1. Overview of the shelf life and assay stability results (n = 2 or n = 3) immediately after production (T0), after 3 months refrigerated storage (T3_5°C), after 1 (T1_25°C/60%RH) and 3 (T3_25°C/60%RH) months storage at 25 °C and 60% RH. Formulations complied to the assay test when the assay of the solutions and capsules was within a 90–110% label claim and 85–115% label claim interval, respectively. aDegradation products of PBA and MBA were detected, bStability data was not collected after 3 months but after 4 months