What is the acceptable range for the labeled active ingredient in compounded preparations?

In compounded preparations, the acceptable range for the labeled active ingredient is typically determined to ensure efficacy and safety for patients. The range of 90%-110% allows for slight variations in the amount of active ingredient present in the compounded product, which can occur due to the inherent variability in the compounding process. This range is widely accepted in pharmaceutical standards and practice because it accommodates minor discrepancies that might arise during the preparation process, while ensuring that the compound remains effective and safe for patient use.

Additionally, this range helps to ensure that the compounded preparation falls within an acceptable threshold for therapeutic effectiveness. It acknowledges the potential for measuring and formulation errors, while still providing a sufficient margin for the product to achieve its intended pharmacological effect. Thus, maintaining an active ingredient concentration within 90%-110% of the labeled amount is critical for the reliability and quality of compounded medications.