Competency information
Details
Perform various spectroscopic techniques, interpret and report the analytical outputs.
Considerations
- How to ensure that samples/products meet the agreed specifications.
- Calibration, maintenance procedures, etc.
- Suitability of instrument.
- System suitability requirements/precision/detection limits etc
- Principles of the techniques used.
- Use the appropriate documentation, e.g. SOPs, worksheets, laboratory information management systems (LIMS).
- Data security, clinical governance, confidentiality, etc.
- Testing requirements for a range of product types: raw materials, finished products, stability samples, other samples.
- Limitation of technique, product characteristics analysed by technique.
- Techniques and instrumentation.
- Volumetric analysis – aqueous and non-aqueous.
- Identification tests, test tube reactions, limit tests.
- Gravimetric analysis.
- Refractometry.
- Melting point.
- Polarimetry.
- Spectroscopy – ultraviolet (UV)/visible.
- Spectroscopy – infrared (IR).
- Spectroscopy – atomic absorption.
- Electrochemistry/pH.
- Particulate measurement, liquids.
- Solid dose forms, physical testing methods (e.g. hardness, friability, disintegration; theoretical only).
- Dissolution (theoretical only).
- Thin-layer chromatography (TLC).
- High-performance liquid chromatography (HPLC).
- Gas chromatography.
- Ion separation chromatography.
- Endotoxin and pyrogen testing.
- Pharmaceutical microbiology – sterility testing, non-sterile product microbiology, water systems testing, preservative efficacy testing.
Relevant learning outcomes
| # | Outcome |
|---|---|
| # 3 | Outcome Perform a range of chemical analytical techniques that provide evidence of product quality to ensure that samples/products meet the agreed specifications analysing, interpreting, reporting and acting on the results. |