Sterility test – Determination by membrane filtration method and Sterility test (by direct inoculation method in culture medium).   Brazilian Pharmacopoeia, 6th ed. 2019 – 5.5.3.2.1, The international Pharmacopoea, 11th 2022 – 3.2, USA Pharmacopoea, 44 – NF 39 2021 – <71>, ISO 11737-2