Trends & Regulatory in Mutagenic/Nitrosamine Impurities | LabRulez GCMS

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

Multi-residue analysis of pesticides in edible oils by triple quadrupole GC-MS

Aplikace
| 2022 | Thermo Fischer Scientific
Instrumentace
GC/MSD, GC/MS/MS, GC/QQQ
Výrobce
Thermo Fischer Scientific
Zaměření
Potraviny a zemědělství

Agilent 5977C GC/MSD

Brožury a specifikace
| 2022 | Agilent Technologies
Instrumentace
GC/MSD, GC/SQ
Výrobce
Agilent Technologies
Zaměření
---

Agilent 7000E and 7010C triple quadrupole GC/MS

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

Method for the determination of 431 Residual Pesticides in Honey using LCMS-8050 and GCMS-TQ8040 NX

Aplikace
| 2022 | Shimadzu
Instrumentace
GC/MSD, GC/MS/MS, GC/QQQ, LC/MS, LC/MS/MS, LC/QQQ
Výrobce
Shimadzu
Zaměření
Potraviny a zemědělství

Determination of Multiclass, Multiresidue Pesticides in Berries

Aplikace
| 2022 | Agilent Technologies
Instrumentace
GC/MSD, GC/MS/MS, Příprava vzorků, GC/QQQ, Spotřební materiál
Výrobce
Agilent Technologies
Zaměření
Potraviny a zemědělství
Další projekty
Sledujte nás
Další informace
WebinářeO násKontaktujte násPodmínky užití

LabRulez s.r.o. Všechna práva vyhrazena.