Why was the practice of calibrating dissolution testers with salicylic acid tablets discontinued?
The practice of calibrating dissolution testers with salicylic acid tablets was discontinued for several reasons:
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Inconsistent Results: Salicylic acid tablets showed variations in their dissolution profiles, which could result in inconsistent and unreliable calibration. This could affect the accuracy and precision of the dissolution test, making it unsuitable as a standard for apparatus calibration.
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Not Representative of All Formulations: Salicylic acid tablets may not be a representative standard for all types of pharmaceutical formulations. Different drugs and formulations can have varied dissolution behaviors, so using one type of tablet (like salicylic acid) wouldn’t necessarily provide a reliable benchmark for all.
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Updated Regulatory Guidelines: Regulatory bodies, such as the FDA and USP (United States Pharmacopeia), have updated their guidelines and moved toward using more appropriate, consistent, and standardized calibration methods. These standards focus on ensuring that dissolution apparatuses perform accurately across a wide range of drug products.
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Better Calibration Standards Available: More reliable and standardized materials, such as specific reference tablets designed for calibration, have become available, providing a better means of ensuring apparatus performance.
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Stability and Storage Concerns: Salicylic acid tablets can be sensitive to environmental conditions like moisture and light, which can impact their dissolution properties. This variability made them less ideal for use as a calibration standard.
In short, more consistent and scientifically robust alternatives for calibration have become the preferred approach, leading to the discontinuation of salicylic acid tablets for this purpose.
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