A list of example quality parameters and analytical techniques used to evaluate them at our GMP laboratory can be found below.
| Quality parameter | Analytical technique |
|---|---|
| Appearance | Visual assessment |
| Physicochemical parameters | Dimensions, pH, solubility |
| Identity | UV-Vis spectroscopy, infrared spectroscopy (IR), characteristic reactions, HPLC/UPLC |
| Content | HPLC, UHPLC (UPLC), GC, UV-Vis, Titration, others upon consultation |
| Content Uniformity | HPLC, UHPLC (UPLC), GC, UV-Vis, Titration, gravimetric, others upon consultation |
| Purity | HPLC, UHPLC (UPLC), TLC, others upon consultation |
| Enantiomeric purity | HPLC, UHPLC (UPLC) |
| Optical rotation | Polarimeter |
| Melting point | Thermometer |
| Dissolution | Blades and baskets using HPLC, UHPLC (UPLC), UV-Vis techniques |
| Residual solvents | GC |
| Particle size | Sieve analysis, laser diffraction |
| Wet chemistry | Characteristic reactions |
FAQ: Quality parameters and analytical techniques at our GMP laboratory
Below you will find answers about the quality parameters and analytical techniques used at our GMP laboratory.
What quality parameters are assessed at our GMP laboratory?
The following quality parameters are assessed at our GMP laboratory:
✅ Appearance
✅ Physicochemical parameters
✅ Identity
✅ Content
✅ Content Uniformity
✅ Purity
✅ Enantiomeric purity
✅ Optical rotation
✅ Melting point
✅ Dissolution
✅ Residual solvents
✅ Particle size
✅ Wet chemistry
What analytical techniques are used to assess appearance?
Visual assessment is used to assess appearance.
What methods are used to analyze physico-chemical parameters?
Physico-chemical parameters such as dimensions, pH and solubility are measured using appropriate techniques, e.g. physical measurements, pH meters and solubility tests.
What techniques are used to confirm the identity of a substance?
The identity of the substance is confirmed by:
✅ UV-Vis spectroscopy
✅ Infrared spectroscopy (IR)
✅ Characteristic reactions
✅ HPLC/UPLC
What methods are used to determine the content of substances?
The substance content is determined using:
✅ HPLC
✅ UHPLC (UPLC)
✅ GC
✅ UV-Vis
✅ Titration
✅ Other methods after consultation
How is content uniformity assessed?
Content uniformity is assessed by:
✅ HPLC
✅ UHPLC (UPLC)
✅ GC
✅ UV-Vis
✅ Titration
✅ Gravimetric methods
✅ Other methods after consultation
What techniques are used to assess cleanliness?
Purity is assessed using:
✅ HPLC
✅ UHPLC (UPLC)
✅ TLC
✅ Other methods after consultation
What methods are used to assess enantiomeric purity?
Enantiomeric purity is assessed by HPLC and UHPLC (UPLC).
How is optical rotation measured?
Optical rotation is measured using a polarimeter.
What techniques are used to measure melting point?
The melting point is measured with a thermometer.
How is the release of substances assessed?
The release of substances is assessed using paddles and baskets in combination with the following techniques:
✅ HPLC
✅ UHPLC (UPLC)
✅ UV-Vis
What methods are used to analyze residual solvents?
Residual solvents are analyzed by gas chromatography (GC).
What techniques are used to measure particle size?
Particle size is measured by:
✅ Sieve analysis
✅ Laser diffraction
What is wet chemistry and what techniques are associated with it?
Wet chemistry involves characteristic reactions performed in solutions, such as qualitative or quantitative tests.
Can other analytical techniques than those mentioned be used?
Yes, other analytical techniques may be used after consultation with the laboratory team if they are appropriate for at least one of given quality parameters.
If you have additional questions, please contact our GMP laboratory.