Elemental impurity analysis of pharmaceutical materials using X-ray fluorescence spectrometry

The recent changes to the United States Pharmacopeia (USP) regarding requirements for elemental impurity testing has peaked interest into new ways to perform this testing. Combining these new requirements with the introduction of USP chapter <735> X-ray fluorescence spectrometry1 permits a new alternate method for quantifying elemental impurities in pharmaceutical materials.

This study demonstrates that the X-ray Fluorescence (XRF) spectrometry is capable of performing elemental analysis of a wide range of pharmaceutical (liquid, powder and solid) materials with high sensitivity, precision and accuracy for many of the elements required by the United States and the European pharmacopeias. Simple sample preparation, non-destructive analysis, no chemical waste, low running costs with a wide dynamic concentration range and good to excellent detection limits are some of the advantages of this technique.

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