01
HPLC & UHPLC
Platform selection, requirements, qualification and troubleshooting in liquid chromatography.
- Performance and method compatibility
- Columns and mobile phases
- Pressure, peaks, baseline and carryover
PL-01 · ANALYTICAL INSTRUMENTATION
Analytical Instrumentation for Pharmaceutical QC
Select the instrument. Demonstrate fitness for the analysis.
Instrument selection does not end with a specification sheet. Define what the instrument must measure, how it must work with the procedure and what evidence supports release and continued use. This domain connects requirements, performance, operation and the lifecycle of analytical instruments.
From instrument to decision.
Instrument families are the starting point. The pathway distinguishes selection, qualification and method controls, without confusing activities that provide different evidence.
02
Qualification & analytical reliability
Understand what instrument qualification, calibration, method validation and system suitability each demonstrate.
- Intended use and requirements
- Tests and documentation
- Controls during use
03
GC & Headspace
Connect instrument configuration, sampling and gases to gas chromatography system performance.
- Inlets and detectors
- Qualification and checks
- Leaks, peaks and retention times
04
Spectroscopy, LC-MS & ICP-MS
Evaluate the platform against the measurement, sample matrix and required performance.
- UV-Vis, FTIR and Raman
- Mass spectrometry interfaces
- Blanks, interferences and verification
05
Dissolution & physical testing
Distinguish the equipment’s mechanical performance from the operating conditions of the test.
- Dissolution and disintegration
- Hardness and friability testers
- Media, temperature and sampling
06
TOC & physicochemical measurements
Start with the sample when choosing the technology, reference materials and relevant controls.
- TOC and Karl Fischer
- pH and conductivity
- Contamination and abnormal results
Define the scope before comparing quotations.
Document matrices, methods, required performance, software, verification responsibilities and support. A useful comparison does not reward the longest feature list: it shows which configuration matches the laboratory’s actual work.
