Batch Release Testing
Analysis of various finished products;
- Tablets,
- Injections,
- Creams,
- Oral solutions
To the customeers finished product release specification.
Tests usually include Identification ;
- Fourier Transform Infra Red Spectroscopy (FTIR)
- Thin Layer Chromatography (TLC)
- Physical tests
- Friability,
- Disintegration
- Average weight
- Dissolution (UV or HPLC),
- Assay and Related Substances (HPLC, UV, GC etc)
Batch Release Testing is usually required when a product is manufactured outside of the EU and then requires re-testing before it can be released onto the market in this country.
ILS now have a ICP-MS Agilent 7500cx Series
Inductively Coupled Plasma – Mass Spectrometry (ICP-MS) is widely acknowledged as the premier technique for trace metal analysis.
• Trace elemental analysis with detection to ppt levels
• Purity and impurity analysis
• Identification of unknown contaminants
• Microwave digestion of “organic” samples
• Routine screening for toxic heavy metals
• Specific elemental method development and validation
• Elemental speciation analysis
• Pharmacopoeia USP/EP/JP and client specific work for elemental analysis.
We are able to handle a diverse sample range: including organic, aqueous, biological, neutraceutical, pharmaceutical and food samples.
Contact ILS - for any further information on batch release testing