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

Table 5 Overview of the shelf life and assay stability results

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; 99.9^a	100.8; 99.9^a	98.5; 97.4^a	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; 100.4^b	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

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

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