Table 2. Stability testing for the products according to the ICH Guideline Q1A.
20°C, 25°C, 30°C | 40°C | |
Laboratory assay | 0, 3, 6, 9, 12 | / |
Eleven batches | 0, 3, 6, 9, 12, 18, 24 | / |
Recent batch | 0, 1, 3, 6 | 0, 1, 2, 3, 4, 5, 6 |
Storage conditions and check points (months) realized on powders obtained with the laboratory assay and the industrial batches (Bacilor®).