Synthesis chromatography system

HPLCfor the pharmaceutical industryfor biomedical research

Overview
The Modular-Lab Analytical HPLC Module is a compact analytical HPLC unit designed for routine quality control of radiolabeled compounds and radiopharmaceuticals. It supports analysis of PET tracers and beta-emitting nuclides, and provides validated ready-to-run routines as well as user-programmable methods for tailored analytical needs.

Supported nuclides and applications
Supports analysis of radiolabeled compounds, including positron-emitting nuclides (18F, 11C, 68Ga) and beta-emitting nuclides (90Y, 177Lu). Intended for routine QC of radiopharmaceuticals, method development and problem-specific analytical tasks.

Operation & integration
The module can be integrated directly into the Modular-Lab synthesizer family or operated as a stand-alone unit with its own control unit and PC. The system includes pre-validated procedures for common tracers, offers user programming for custom methods, and includes operator training. Optional on-site performance qualification (PQ) of defined analytical procedures is available.

Key features

• Seamless integration into Modular-Lab systems
• Compact footprint and cost-efficient compared with full-scale analytical HPLC systems
• Validated ready-to-run routines for many tracers
• Customizable for additional analytical applications

Standard/typical system configuration
A typical standard configuration includes:

• HPLC module with injection valve, shielded activity detector and column holder
• Knauer AZURA pump 4.1S (single or optional second pump for gradient operation)
• Knauer UV detector UVD 2.1S
• Knauer HPLC Online-Degasser
• HPLC column, tubing and connectors
• Control unit, PC and dedicated software for control and data evaluation

Chromatography modes & data evaluation
The base system performs isocratic analyses; adding a second pump enables gradient elution. Dedicated software provides background correction, peak analysis and curve fitting. Processed data can be exported as tables and compiled into QC reports.

Advantages
The module delivers a multifunctional solution for routine HPLC QC of PET tracers and beta-emitting nuclides, reducing footprint and cost while offering validated methods and the ability to develop customized analytical solutions.

CE Conformity
CE conformity certificates are available for this product.

Technical specifications

• Product name: Modular-Lab HPLC Unit
• Intended use: Analytical HPLC for radiolabeled compounds and radiopharmaceutical QC
• Compatible nuclides: 18F, 11C, 68Ga, 90Y, 177Lu (examples)
• Operation modes: Isocratic (standard); gradient (with second pump)
• Typical detectors: Shielded activity detector, UV detector (Knauer UVD 2.1S)
• Typical pumps: Knauer AZURA pump 4.1S (optional second pump for gradient)
• Accessories in standard setup: Injection valve, column holder, online degasser, HPLC column, tubing and connectors
• Control & software: Dedicated control unit and PC; data evaluation with background correction, peak analysis and curve fitting; table export and report generation
• Integration: Connectable to Modular-Lab synthesizer family or usable as stand-alone device
• Validation & support: Pre-validated routines installed; operator training included; optional on-site PQ available