What is the role of current mass spectrometry in pharmaceutical analysis?

Kód výsledku v IS VaVaI

<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F60461373%3A22340%2F23%3A43926969" target="_blank" >RIV/60461373:22340/23:43926969 - isvavai.cz</a>

Výsledek na webu

<a href="https://analyticalsciencejournals.onlinelibrary.wiley.com/doi/10.1002/mas.21858" target="_blank" >https://analyticalsciencejournals.onlinelibrary.wiley.com/doi/10.1002/mas.21858</a>

DOI - Digital Object Identifier

<a href="http://dx.doi.org/10.1002/mas.21858" target="_blank" >10.1002/mas.21858</a>

Jazyk výsledku

angličtina

Název v původním jazyce

What is the role of current mass spectrometry in pharmaceutical analysis?

Popis výsledku v původním jazyce

The role of mass spectrometry (MS) has become more important in most application domains in recent years. Pharmaceutical analysis is specific due to its stringent regulation procedures, the need for good laboratory/manufacturing practices, and a large number of routine quality control analyses to be carried out. The role of MS is, therefore, very different throughout the whole drug development cycle. While it dominates within the drug discovery and development phase, in routine quality control, the role of MS is minor and indispensable only for selected applications. Moreover, its role is very different in the case of analysis of small molecule pharmaceuticals and biopharmaceuticals. Our review explains the role of current MS in the analysis of both small-molecule chemical drugs and biopharmaceuticals. Important features of MS-based technologies being implemented, method requirements, and related challenges are discussed. The differences in analytical procedures for small molecule pharmaceuticals and biopharmaceuticals are pointed out. While a single method or a small set of methods is usually sufficient for quality control in the case of small molecule pharmaceuticals and MS is often not indispensable, a large panel of methods including extensive use of MS must be used for quality control of biopharmaceuticals. Finally, expected development and future trends are outlined.

Název v anglickém jazyce

What is the role of current mass spectrometry in pharmaceutical analysis?

Popis výsledku anglicky

The role of mass spectrometry (MS) has become more important in most application domains in recent years. Pharmaceutical analysis is specific due to its stringent regulation procedures, the need for good laboratory/manufacturing practices, and a large number of routine quality control analyses to be carried out. The role of MS is, therefore, very different throughout the whole drug development cycle. While it dominates within the drug discovery and development phase, in routine quality control, the role of MS is minor and indispensable only for selected applications. Moreover, its role is very different in the case of analysis of small molecule pharmaceuticals and biopharmaceuticals. Our review explains the role of current MS in the analysis of both small-molecule chemical drugs and biopharmaceuticals. Important features of MS-based technologies being implemented, method requirements, and related challenges are discussed. The differences in analytical procedures for small molecule pharmaceuticals and biopharmaceuticals are pointed out. While a single method or a small set of methods is usually sufficient for quality control in the case of small molecule pharmaceuticals and MS is often not indispensable, a large panel of methods including extensive use of MS must be used for quality control of biopharmaceuticals. Finally, expected development and future trends are outlined.

Druh

J_imp - Článek v periodiku v databázi Web of Science

CEP obor

—

OECD FORD obor

10406 - Analytical chemistry

Projekt

—

Návaznosti

S - Specificky vyzkum na vysokych skolach<br>I - Institucionalni podpora na dlouhodoby koncepcni rozvoj vyzkumne organizace

Rok uplatnění

2023

Kód důvěrnosti údajů

S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů

Název periodika

Mass Spectrometry Reviews

ISSN

0277-7037

e-ISSN

1098-2787

Svazek periodika

neuveden

Číslo periodika v rámci svazku

2023

Stát vydavatele periodika

US - Spojené státy americké

Počet stran výsledku

50

Strana od-do

1-50

Kód UT WoS článku

001037413700001

EID výsledku v databázi Scopus

2-s2.0-85165913551