Compliant nitrogen content analysis for the pharmaceutical industry

Download our Essentials for Compliance ​in Pharma to fulfill the 21 CFR Part 11

Discover the KjelMaster K-375 Pharma Package features

The Pharma Package makes Kjeldahl analysis fully applicable for the Pharma industry, all new features are aligned with the 21 CFR Part 11 requirements:

IQ/OQ and training
Data records
Data traceability
Electronic signature
Security
User Administration
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Kjeldahl applications in the Pharma Industry

The Kjeldahl analysis is a very robust, primary reference method to measure nitrogen contents in various matrices. Different application fields can be found, where the total nitrogen content plays an important role for analyte quantification:

APIs:
Nutraceuticals
Ointments
Biopharmaceuticals
Blood plasma products:
Biomaterials
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“The BUCHI Kjeldahl equipment is a unique combination of sample digester, scrubber, distiller and titrator. All work in conjunction and provide integrated reproducible data. It is a user friendly and time saving equipment. Its advanced automation reduces labor cost and is very much useful in pharmaceutical industry.”

Ph.D. Venkat Reddy Guduru

Bactolac Pharmaceutical, Inc.

KjelMaster K-375 - the instrument for the Pharma industry

Flexible operation

  • Comply with the official Kjeldahl norms (AOAC, EPA, USP, ISO, EC and DIN) thanks to the choice of colorimetric, potentiometric or back titration setup
  • Automatic data exchange with peripherals (balance, bar code reader, printer, LIMS and more)

Use different and secured access levels of authorization, thorough reporting and tracked data manipulation.

Easy to use

  • Control and input data via the large graphical color touch screen (8.4")
  • Attach via LAN to the network and make use of traceable data management
  • Ease your daily work with BUCHI’s Kjeldahl Apps (Kjeldahl Optimizer and Kjeldahl Tablet Configurator)

Avoid downtimes with preventative maintenance and tailored service packages.

Maximized productivity

  • Shortest time-to-result due to well synchronized process steps
  • Upgrade onsite for highest sample loads by connecting the KjelSampler to the KjelMaster
  • Fully automated workflow for high sample loads synchronized with digestion process

Quick determinations of priority samples while a running sequence using “Express Racks” with KjelSampler.