Case Study: Ingredient Interference—Solving an OOS Issue in a Vitamin Chew
A client submitted a vitamin chew for testing, but results were inconsistent, and some batches showed OOS values. Upon reviewing the ingredient list, analysts noticed a wax component with a melting point higher than the water bath temperature specified in the method.
This detail proved crucial. The wax wasn’t fully dissolving during sample prep, which interfered with the extraction of the active ingredient. The lab worked closely with the client to modify the method—specifically increasing the water bath temperature to ensure complete dissolution of the wax.
Additionally, the lab helped the client develop product-specific procedural notes to accompany future submissions, ensuring that this unique formulation would be handled correctly every time.
Key Takeaway
Ingredient properties can significantly impact method performance. Tailoring procedures to accommodate unique formulations is essential for accurate and consistent results.
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