According to revised USP <795>, the maximum BUD for a non-preserved aqueous dosage form is:

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Multiple Choice

According to revised USP <795>, the maximum BUD for a non-preserved aqueous dosage form is:

Non-preserved aqueous dosage forms have a higher risk of microbial growth because they contain water and no preservative. To keep safety, USP <795> sets a short target date for use when such formulations are refrigerated, since chilling slows microbial growth. Therefore, the maximum BUD is 14 days when stored in the refrigerator (2–8°C). Store-at-room-temperature would not provide the same level of microbial control, so 14 days at room temperature isn’t appropriate. Linking the BUD to the earliest expiration of any API (or to 90 days) or saying it’s not applicable doesn’t align with the guidance for non-preserved aqueous forms, where a 14-day refrigerated window is the defined limit.

Non-preserved aqueous dosage forms have a higher risk of microbial growth because they contain water and no preservative. To keep safety, USP <795> sets a short target date for use when such formulations are refrigerated, since chilling slows microbial growth. Therefore, the maximum BUD is 14 days when stored in the refrigerator (2–8°C).

Store-at-room-temperature would not provide the same level of microbial control, so 14 days at room temperature isn’t appropriate. Linking the BUD to the earliest expiration of any API (or to 90 days) or saying it’s not applicable doesn’t align with the guidance for non-preserved aqueous forms, where a 14-day refrigerated window is the defined limit.

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