User:Anxietycello/sandbox
Pharmaceutical quality control is a laboratory-based process that ensures that drugs meet specification during pharmaceutical manufacturing. It involves a series of laboratory techniques including but not limited to:
- Techniques that are used to monitor the chemical concentration of active ingredient
- Assay / degradation
- Uniformity of content
- Thin layer chromatography
- High performance liquid chromatography
- Ultra performance liquid chromatography
- Gas chromatography
- Infrared spectroscopy
- Ultraviolet–visible spectroscopy
- Techniques that monitor the physical properties of the drug
- Hausner ratio
- Sieve analysis
- The average weight of a tablet
- Tablet hardness testing
- Friability
- Loss on drying (i.e. Moisture analysis - also Karl Fischer titration)
- Dissolution (chemistry) (i.e. solubility)
- Disintegration
- Techniques that verify the suitability of manufacturing apparatus
If drugs meet specification, a Qualified Person releases the drug to general sale. Quality control is an integral part of manufacturing so as to ensure the drug behaves as intended, and reduces the chance of a drug recall.
Equipment used
[edit]- analytical balance
- pipette
- volumetric flask
- shaker (laboratory)/magnetic stirrer/sonicator
- vacuum oven
- dessicator
- hardness tester
- friabilator
- disintegration tester
- dissolution bath