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Non-Sterile Diluents

Meaning

Non-Sterile Diluents are liquid substances, such as bacteriostatic water or specific solvent mixtures, that are used to dissolve or dilute a concentrated active compound but have not undergone a terminal, validated sterilization process. While these diluents may contain preservatives to inhibit microbial growth, they fundamentally do not meet the rigorous sterility assurance standards required for preparations intended for intravenous or intraocular administration. Their use is typically restricted to preparations where the route of administration carries a low risk of systemic infection.