ОТНОСТНО ТОЗИ ЕПИЗОД
This week Mike and Ashley explain the J value used in pharmaceutical elemental impurity testing to relate typical ICP concentration units to permitted daily exposure (PDE) limits reported in micrograms per day under USP <232> and ICH Q3D. They describe how J value accounts for both sample dilution factor and maximum daily dose, making results comparable to PDE requirements. They recommend preparing method standards at PDE limits for the relevant administration route and diluting to match the J calculation for method validation.
Английски
САЩ
ТРАНСКРИПЦИЯ 🔗
Are you the producer of this podcast?
Add a podcast transcript
Need Audio-to-Text?
Transcribe with Listen411 in Just 60 Seconds
ТЪРСЕНЕ на МИНАЛИ ЕПИЗОДИ
Търсене в минали епизоди на Bench Boost by Inorganic Ventures.
ДРУГИ ЕПИЗОДИ В ТОЗИ ПОДКАСТ
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 calculati…
Send us Fan Mail
The Inorganic Ventures team members answer more listener questions relevant to trace analysis. They address low mercury recovery at 2 ppb, noting mercury instability in nitric acid, adsorption to plastic, options such as preparing in HCl or stabilizing with ~1 ppm gold. They explai…
Send us Fan Mail
This week on Bench Boost Mike shares practical tips for analyzing pharmaceutical samples at low concentrations for USP 232 elemental impurities, emphasizing that high dilution makes small contamination or carryover issues critical. He advises minimizing contamination through carefu…
Send us Fan Mail
The Inorganic Ventures team answers listener questions focused on pharmaceutical elemental impurity analysis by ICP-MS. They explain why an indium internal standard becomes unstable in high-pH matrices due to insoluble hydroxide formation and how EDTA complexation can stabilize ind…
Опровержение: Подкастът и произведенията на изкуството, вградени на тази страница, са от Inorganic Ventures, което е собственост на неговия собственик и не е свързано с или одобрено от Listen Notes, Inc.
РЕДАКТИРАНЕ
Благодарим Ви, че помогате да поддържаме базата данни за подкастове актуална.
