Good Manufacturing Practice (GMP) regulations for medicinal products define batch release of these products in accordance with the approved product specification. Our laboratories have a wide range of analytical techniques to ensure proper testing in accordance with pharmacopoeial or client-defined methods and to verify that the properties of the released product comply with the defined specification.
By routinely processing a wide range of pharmaceutical matrices, ALS is fully prepared to meet the needs of its clients, their expanding portfolios and various product lines.
Commonly analysed matrices include:
- Tablets
- Capsules
- Powders and granules
- Syrups
- Creams, ointments and gels
- Oral and other liquids
We offer both chemical and microbiological tests:
- Disintegration
- Dissolution profiles
- Dimensions and hardness of solid dosage forms
- Determination of active substance content
- Determination of excipient content
- HPLC - UV, RI, DAD detectors
- GC-FID; headspace
- Ion chromatography
- Identification using FTIR
- Complete microbiological testing - total microorganism counts, pathogens, PET test, bacterial endotoxins
- Elemental contamination using ICP-M