Uniquely for nasal sprays, the stability testing program must include device performance tests spray content uniformity (SAC) and droplet size distribution (DSD) at stability time points alongside the standard formulation tests (assay, impurities, pH, appearance, viscosity)
Adv Pharmacol 38:20527, PMID: 8895810 Jain A, Mrtensson J, Stole E, Auld PA, Meister A (1991) Glutathione deficiency leads to mitochondrial damage in brain
References McCoy AT, Benoist CC, Wright JW, Kawas LH, Bule-Ghogare JM, Zhu M, Appleyard SM, Wayman GA, Harding JW
A standard method is gamma irradiation, which sterilizes cleanroom wipes, achieving a Sterility Assurance Level (SAL) of 10^6meaning a one-in-a-million chance of a viable microorganism
These options are never used in isolation
It's also important to know if tesofensine is available where you are