Trends & Regulatory in Mutagenic/Nitrosamine Impurities | LabRulez LCMS

Recent Trends & Regulatory Developments in Mutagenic/Nitrosamine Impurities Analysis

ZÁZNAM | Proběhlo Pá, 24.6.2022
Procesy výroby léčiv jsou hodnoceny s cílem identifikovat a kontrolovat zdroj kontaminace v API a léčivých produktech.
Agilent Technologies: Recent Trends & Regulatory Developments in Mutagenic/Nitrosamine Impurities Analysis

Agilent Technologies: Recent Trends & Regulatory Developments in Mutagenic/Nitrosamine Impurities Analysis

In 2018, several ARB-class drug products were recalled due to the presence of unacceptable levels of mutagenic nitrosamine impurities. Since then, more classes of drugs have been added to the list, newer impurities are being monitored, and regulatory limits for identification and quantification are going down.

Drug manufacturing processes are being evaluated to identify and control the source of contamination in APIs and drug products.

Understanding of this evolving regulatory landscape has become critical for confident analysis and release of the drug product.

What will be discussed:
  • Latest regulatory developments for detection and quantification of mutagenic impurities in APIs and drug products
  • Learn about newer classes of drugs and mutagenic impurities being monitored by regulatory agencies
  • Simplify understanding of current analytical guidelines published by regulatory bodies like USFDA & EMA

Presenter: Chander Mani (Application Specialist, Agilent Technologies, extensive research on nitrosamine applications)

Agilent Technologies
 

Mohlo by Vás zajímat

Waters XEVO G3 QTof

Brožury a specifikace
| 2022 | Waters
Instrumentace
LC/TOF, LC/HRMS, LC/MS, LC/MS/MS
Výrobce
Waters
Zaměření
---

Normal phase liquid chromatography assay for vitamin K1 isomers

Aplikace
| 2022 | Thermo Fischer Scientific
Instrumentace
HPLC
Výrobce
Thermo Fischer Scientific
Zaměření
Potraviny a zemědělství

Agilent 6475 triple quadrupole LC/MS

Brožury a specifikace
| 2022 | Agilent Technologies
Instrumentace
LC/MS, LC/MS/MS, LC/QQQ
Výrobce
Agilent Technologies
Zaměření
---

Shimadzu Liquid Chromatograph Mass Spectrometer LCMS-2050

Brožury a specifikace
| 2022 | Shimadzu
Instrumentace
LC/MS, LC/SQ
Výrobce
Shimadzu
Zaměření
---

Overcoming the challenges of liquid chromatography method transfer: A CDMO perspective

Technické články
| 2022 | Thermo Fischer Scientific
Instrumentace
HPLC
Výrobce
Thermo Fischer Scientific
Zaměření
---
Další projekty
Sledujte nás
Další informace
WebinářeO násKontaktujte násPodmínky užití

LabRulez s.r.o. Všechna práva vyhrazena.