Nonaqueous Oral Liquid Formulation BUD?

Nonaqueous Oral Liquid Formulation BUD?

• A. 14 days
• B. 28 days
• C. 90 days
• D. 180 days

Answer: (C)

Nonaqueous formulations have a longer beyond-use date because they contain little to no water, which limits both microbial growth and hydrolytic degradation. Under USP guidelines, the BUD for nonaqueous formulations is no more than six months (180 days), unless the earliest expiration date of any ingredient is sooner. So for a nonaqueous oral liquid, the appropriate BUD is 180 days, provided none of the ingredients expire earlier.

Nonaqueous formulations have a longer beyond-use date because they contain little to no water, which limits both microbial growth and hydrolytic degradation. Under USP guidelines, the BUD for nonaqueous formulations is no more than six months (180 days), unless the earliest expiration date of any ingredient is sooner. So for a nonaqueous oral liquid, the appropriate BUD is 180 days, provided none of the ingredients expire earlier.