Are you ready for new United States Pharmacopeia 232, 233, and 2232 and also ICH Q3D pharma regulations considering inorganic elemental impurities?
We hope yes, but maybe you are not. Frequently pharma laboratories are a world of chromatographs used for organic analysis. Now we are moving for a room with inductively coupled plasmas with optical emission or mass spectrometers (you will get used to new acronyms: ICP OES and ICP-MS).
Yes, you will have new analytical instruments in your lab. Together with ICPs, you will also be engaged in sample preparation. You will use new procedures for as complete as possible oxidation of organic compounds and destruction of excipients followed by the determination of elemental constituents liberated in the liquid phase. Microwave-assisted preparation in closed vessels will become an important ally.
This is the topic of this book where two analysts talk about this new demand and how to get prepared for it. A Q&A style was adopted for making your reading easier and funnier. The authors hope you enjoy it.