Pharma Elemental Analysis Overview
Failed to add items
Sorry, we are unable to add the item because your shopping cart is already at capacity.
Add to basket failed.
Please try again later
Add to wishlist failed.
Please try again later
Remove from wishlist failed.
Please try again later
Adding to library failed
Please try again
Follow podcast failed
Unfollow podcast failed
Pharma Elemental Analysis Overview
-
Narrated by:
-
By:
Summary
Send us Fan Mail
This week Mike & Ashley review the standardized methods for elemental impurity analysis in pharmaceuticals: ICH Q3D, USP <232>, and USP <233>. ICH Q3D provides guidelines for testing up to 24 elements and emphasizes risk assessment but not detailed testing calculations; USP <232> sets elemental impurity limits; and USP <233> addresses sample preparation and analysis and relies on ICH Q3D concepts such as “J” concentrations (to be covered next week). They explain risk assessment factors (element, route of administration, intentional addition, and screened materials) and outline element classes. They also discuss sample types (APIs, drug products, excipients) and how early screening can reduce final testing needs.
adbl_web_anon_alc_button_suppression_c
No reviews yet