Dose Inhalations and Nasal Aerosols

Metered-dose inhalations and nasal aerosols should be evaluated for appearance (including content, container, and the valve and its components), color, taste, assay, degradation products, assay for cosolvent (if applicable), dose content uniformity, labeled number of medication actuations per container meeting dose content uniformity, aerodynamic particle size distribution, microscopic evaluation, water content, leak rate, microbial limits, valve delivery (shot weight), and extractables and leachables from plastic and elastomeric components. Samples should be stored in upright and inverted/on-the-side orientations. 

Because the inhalant drug products are intended for use in the respiratory system, confirmation that initial release specifications are maintained should be provided to ensure both the absence of pathogenic organisms (e.g., Staphylococcus aureus, Pseudomonas aeruginosa, Escherichia coli, and Salmonella species) and that the total aerobic count and total mold and yeast count per canister are not exceeded. 

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Metered-Dose Inhalers and Nasal Aerosols Content uniformity, aerodynamic particle size distribution, microscopic evaluation, water content, leak rate, microbial bioburden, valve delivery, extractables, leachables from plastic and elastomeric components. 

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