Regulatory Updates
USP vs EP impurity naming, side by side
The same compound can carry an EP impurity letter, a USP related compound letter and a catalogue name. How to map them from structure rather than from the letter.
Resources
Regulatory Updates
Regulatory developments that change what you need from a reference standard: ICH M7 mutagenic impurity classification, nitrosamine acceptable intakes, and how USP and EP label the same related compound.
Regulatory Updates
ICH M7 in practice: classifying and controlling mutagenic impurities
How Class 1 to 5 assignment, the 1.5 microgram per day threshold and the four control options change what you need from a reference standard.