Pharmaceutical & Biopharma
Elemental impurities, residual solvents and QC sample prep.
The workflow
Pharmaceutical QC rewards consistency more than speed. The method has to produce the same result on the ten-thousandth sample as it did during validation — which makes sample preparation and data integrity the critical design constraints.
The catalog covers both: microwave digestion and automated liquid handling for elemental impurity workflows, ICP-MS and ICP-OES detection, HPLC for assay and impurity testing, and software with the audit-trail and permission controls that regulated laboratories expect.
What makes it difficult
- Validating elemental impurity methods to ICH Q3D expectations
- Avoiding contamination during trace-level sample preparation
- Demonstrating data integrity with audit trails and user permissions
- Scaling QC sample preparation without adding analysts
Typical samples
Recommended systems
Microwave Digestion · ICP-MS · Liquid Handling · Liquid Chromatography · Acid Purification
Step by step
How the sample moves.
Prepare
Closed-vessel microwave digestion or direct dilution, with automated acid dispensing.
Acid Handling →Automate
Robotic liquid handling for aliquoting, dilution and standard preparation.
Liquid Handling →Analyze
ICP-MS and ICP-OES for elemental impurities; HPLC for assay and related substances.
ICP-MS →Document
Software with audit trails and permission management for regulated environments.
Atomic Spectroscopy →Systems
Recommended for Pharmaceutical & Biopharma.
One pressurized chamber at 300 °C and 200 bar, with no vessel assembly.
Single-quadrupole and triple-quadrupole trace-element analysis.
Gravimetric liquid handling and machine-vision dilution for analytical sample preparation.
Isocratic and binary high-pressure gradient HPLC for mixture analysis.
Sub-boiling acid purification and reflux cleaning for ultra-trace blanks.
Send us the regulation and the limit
We map it to a LabTech configuration and tell you where the catalog stops short of your specification.