|
 |
|
|
| |
|
Newsletter Sponsor
|
|
USP Compliance with the New Shimadzu EDX-7000 X-ray Fluorescence Spectrometer
On January 1, 2018, USP <232> and USP <233> will go into effect, supplanting USP <231> as the new limits and test procedures for elemental impurities. Additionally, USP <735> is a new chapter permitting the use of X-ray fluorescence in pharmaceutical testing. These impurities are of significant concern within pharmaceutical products, in terms of both toxicity, as well as stability (and thus shelf-life). Elemental impurities include catalysts and environmental contaminants that may be present in drug substances, excipients, or drug products. They may occur naturally, be added intentionally, or be introduced inadvertently.
 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
