Direkt zum Inhalt
  • ELGA weltweit
  • Über ELGA
    • Über ELGA
    • Karriere
    • Veranstaltungen
  • Service
    • Laborplanung
    • Ein Produkt registrieren
    • Register Your Product (USA & Canada Only)
  • Kontakt
  • U.S.A.
  • U.K.
  • España
  • France
  • Italia
  • Brasil
  • 日本
  • 中国
Startseite ELGA LabWater
  • Produkte
    • PURELAB
    • CENTRA
    • MEDICA
    • BIOPURE
    • Komplette Produktpalette
  • Anwendungen
    • Allgemeiner Laborwasserbedarf
    • Atomspektroskopie
    • Elektrochemie
    • Flüssigchromatographie
    • Gaschromatographie
    • Genetik
    • Immunchemie
    • Klinische Biochemie
    • Massenspektrometrie
    • Mikrobiologische Analyse
    • Spektrophotometrie
    • Zellkulturen
  • Technologien
    • Aktivkohle
    • Elektroentionisierung (EDI)
    • Filtration
    • Ionenaustausch
    • PureSure
    • Ultraviolettes Licht (UV)
    • Umkehrosmose (RO)
  • Verunreinigungen im Wasser
    • Anorganische Verbindungen
    • Gelöste Gase
    • Mikroorganismen und Bakterien
    • Organische Verbindungen
    • Partikel
  • Wissen
    • Blog
    • Referenzen
    • Reinstwasser
    • Whitepaper rund um Laborwasser
  • Produkte
    • PURELAB
    • CENTRA
    • MEDICA
      • Hubgrade
      • MEDICA BIOX
    • BIOPURE
    • Komplette Produktpalette
      • PURELAB® Classic
  • Anwendungen
    • Allgemeiner Laborwasserbedarf
    • Atomspektroskopie
    • Elektrochemie
    • Flüssigchromatographie
      • Hochleistungsflüssigkeitschromatographie (HPLC)
    • Gaschromatographie
    • Genetik
    • Immunchemie
    • Klinische Biochemie
    • Massenspektrometrie
    • Mikrobiologische Analyse
    • Spektrophotometrie
    • Zellkulturen
  • Technologien
    • Aktivkohle
    • Elektroentionisierung (EDI)
    • Filtration
    • Ionenaustausch
    • PureSure
    • Ultraviolettes Licht (UV)
    • Umkehrosmose (RO)
  • Verunreinigungen im Wasser
    • Anorganische Verbindungen
    • Gelöste Gase
    • Mikroorganismen und Bakterien
    • Organische Verbindungen
    • Partikel
  • Wissen
    • Blog
      • Analytical Chemistry
      • Clinical & Pharma
      • Cool Science
      • Environment and sustainability
      • Life in the lab
      • Purelab product design
      • Science of the future
      • Water Purity
      • Water in the lab
    • Referenzen
      • Abbott Diagnostics entscheidet sich für ELGA MEDICA Systeme in Südasien
      • Beam Me Up, Scotty: PURELAB® Option Q Delivers Essential Ultra Pure Water
      • Argenta chooses DKSH New Zealand to deliver Ultrapure water in Animal Pharma
      • Clean Water for a Clean Future
      • LS Scientific & ELGA deliver UltraPure water to the NAFDAC Laboratory
      • Lifebrain Group chooses ELGA as water partner for new modern 24/7 PCR-COVID-19 laboratory in Vienna, Austria.
      • Critital Tests Benefit from PURELAB® Option Reliable Pure Water
      • DASA: Das größte medizinische Diagnostikunternehmen in Brasilien
      • ELGA unterstützt Immunserologie-Labore bei der Maximierung der Betriebszeit
      • Fondazione Telethon Continues to Choose ELGA Labwater as a Trusted Partner
      • Bedeutung von Reinstwasser Typ 1+ für die Entwicklung von Generika
      • MEDICA® Pro ausgewählt für Siemens ADVIA® Analysatoren im City General Hospital
      • Optimale Wasserqualität für mikrobiologische Forschung und Lehre
      • PURELAB® Option R Guarantees Pure Water for Leading Microfluidics Technology
      • PURELAB® Pulse Delivers Reliable Water Quality and Quantity for a Wide Range of Applications
      • PURELAB® flex: ein ideales Trainingssystem für heutige Forschungsverfahren
      • Powering Cutting-Edge Gene Research
      • Sichere Reinstwasserversorgung für präzise Produkttests
      • Zentrale Reinstwasser-Aufbereitung für Analyser
      • ELGA LabWater and Beckman Coulter Join Forces
      • Applied New Technologies Department Improves ICP, IC & HPLC Sample Turnaround Times with PURELAB®
      • Die Geheimnisse der Antarktis mithilfe von Reinstwasser entschlüsseln
      • Advancing Genetic Technologies
      • Cross Infection Control: Pure and Simple
      • Researching effective new ways to prevent cardiovascular disease at the University of Columbia
    • Reinstwasser
    • Whitepaper rund um Laborwasser
      • Klinische Risiken reduzieren
      • Nachhaltigkeit
  • U.S.A.
  • U.K.
  • España
  • France
  • Italia
  • Brasil
  • 日本
  • 中国
  • Datenschutzerklärung
  • Geschäftsbedingungen
  • Globale Entsprechenserklärungen
  • Patente
  • Impressum
  • Startseite
  • Extractables and Leachables: an Ultrapure Water Requirement
Clinical & Pharma
Water Purity

Extractables and Leachables: an Ultrapure Water Requirement

12 Feb. 2020
- by Dr Paul Whitehead

A laboratory assistant is operating with pipette and sample on flat glass with the total medical service and scientific unit system. The concept of innovative researches and medicine correlation.

When it comes to medicinal drugs, it is essential that no chemical species is introduced which could possibly interact with and impact on the safety, quality and efficacy of the drug. Extractables and leachables both migrate from the packaging into the drug however, migration for extractables is facilitated by a solvent, while leachables migrate with direct contact at room temperature.

In this blog, Dr Paul Whitehead investigates the testing of extractables and leachables and why ultrapure water is required to ensure ultimate quality.

The increased awareness of potential hazards from chemicals leaching into medicines and the availability of higher sensitivity techniques to detect them has lead to an increased requirement for ultrapure water of the highest purity.

The testing of extractables and leachables focuses on detecting and identifying chemical species that can enter drugs from manufacturing components, packaging and drug delivery systems. The Food and Drug Administration (FDA) defines extractables as compounds that can be extracted from the packaging or contact closure system (CCS) in the presence of a solvent and leachables as compounds that leach into the drug product formulation from the container or CCS as a result of direct contact with the formulation. Among others, the FDA and the European Medicines Agency (EMA) require packaging material data from extraction studies and interaction studies to be provided by the drug manufacturers.

Generally, components are contacted with various solvents (e.g. water, ethanol and hexane) and the compounds released – metals, volatile, semi-volatile and low-volatile organics – are determined by mass spectrometry – ICP-MS, GC-MS and LC-MS. Compounds detected are assessed toxicologically. Ideally, all compounds extracted should be identified. High resolution mass spectrometry has greatly assisted in this, especially electron ionization (EI) spectra from GC-MS, which are library-searchable. There are a vast number of potential contaminants – there are 9,000 to 10,000 different polymer contact closure systems alone – and often standard products are adapted to other applications.

Similar studies need to be carried out on leachables – these require greater analytical sensitivity with the added challenges of potential interferences from the matrix during analysis, possible new components formed by reaction with the drug and low leach rates. The increased reliance on disposable, single-use components presents a further complication.

Overall, extractables and leachables involves an extensive range of analyses of all types at ultra-trace levels. Purified water is needed at all stages of the process – for extraction media, for sample storage containers and during analysis for sample preparation, blanks, standards and chromatographic media. Due to the diverse and unknown range of contaminants that might be encountered, ultrapure water of the highest purity, both organically and inorganically, is essential. In pharmaceutical labs this may be an additional, higher-purity water requirement on top of the water purity needed for routine analyses. In some such labs the water polisher could be fed by USP, JP or EP grade purified water.

 

Dr Paul Whitehead 

After a BA in Chemistry at Oxford University, Paul focused his career on industrial applications of chemistry. He was awarded a PhD at Imperial College, London for developing a microwave-induced-plasma detector for gas chromatography. He spent the first half of his career managing the analytical support team at the Johnson Matthey Research/Technology Centre,specialising in the determination of precious metals and characterising applications such as car-exhaust catalysts and fuel cells. Subsequently, as Laboratory Manager in R&D for ELGA LabWater, he has been involved in introducing and developing the latest water purification technologies. He now acts as a consultant for ELGA.

Pure Water Essence of the Lab Whitepaper download

How well do you know your ultrapure lab water?

Do you know the most effective way to use ultrapure water, your most fundamental reagent? Read our full whitepaper and discover how you can make sure that your pure water supply delivers the performance you need to produce reliable and accurate results.

          Read the Whitepaper

 

 

  • Anfrage
  • Angebot anfordern
  • Produkt-Vorführung buchen
  • Einen Ansprechpartner finden

Anfrage

Ich habe die Datenschutzerklärung gelesen und verstanden

Angebot anfordern

Ich habe die Datenschutzerklärung gelesen und verstanden

Produkt-Vorführung buchen

Ich habe die Datenschutzerklärung gelesen und verstanden

Call us

Can't find what you are looking for?

Support Number
+44 (0)20 3567 7300
United Kingdom Sales
+44 (0)1628 879 704
United States of America Sales
+1 877-315-3542
France Sales
+33 1 40 83 65 00
China Sales
+86 400-616-8882

 

ELGA LabWater US Headquarters

ELGA LabWater
Veolia Water Technologies Deutschland GmbH
Lückenweg 5
29227 Celle
T: +49 (0) 51 41 803 0
F: +49 (0) 51 41 803 384

ELGA LabWater Deutschland

ELGA LabWater
Veolia Water Technologies Deutschland GmbH
Lückenweg 5
29227 Celle
T: +49 (0) 51 41 803 0
F: +49 (0) 51 41 803 384

Referenzen

  • Abbott Diagnostics
  • DASA Medical Diagnostics
  • NeoDIN Medical Institute
  • North Staffordshire NHS Trust
  • Berufskolleg Olsberg

Ressourcen

  • Erfahren Sie mehr über Reinstwasser
  • Whitepaper rund um Laborwasser
  • Technologien zur Wasseraufbereitung
  • Laboranwendungen
  • Verunreinigungen im Wasser

Blogs

  • Latest Blog
  • Water Purity - Different Types of Pure Water
  • What is Clinical Laboratory Reagent Water (CLSI)?
  • What is Total Organic Carbon (TOC)?
  • Sprache
    • Deutsch
    • English
    • Español
    • Français
    • Italiano
    • Português
    • 日本語
    • 中文
  • Andere Veolia Webseiten
    • Veolia
    • Veolia Foundation
    • Veolia Water Technologies

© VWS (UK) Ltd, handelnd als ELGA LabWater.2023- Alle Rechte vorbehalten.
ELGA ist der globale Markenname von Veolia für Laborwasser.

  • Datenschutzerklärung
  • Geschäftsbedingungen
  • Globale Entsprechenserklärungen
  • Patente
  • Impressum
Elga Veolia
TOP

© 2017 ELGA Veolia