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All medicines, including animal health products, which are making a medicinal claim are subject to rigorous scrutiny by the MHRA (Medicines & Healthcare Products Regulatory Agency) before they can be made available in the UK. This ensures that medicines meet acceptable standards on safety, quality and efficacy. Any laboratory analysing manufactured products making medicinal claims is subject to regular auditing by the MHRA to ensure that the laboratory meets its high standards. Sciantec holds approval from the MHRA for this work (GMP compliant).
The animal health section undertakes analysis of pharmaceutical samples and premixes to Pharmacopoeia, in house or to client’s own methods. Sciantec has significant expertise in this area and has provided a service to the pharmaceutical sector for more than 15 years.
Storage Stability Trials
The laboratory have facilities for accelerated and long term storage stability trials, with samples stored under VICH and ICH guidelines or specific to client requirements.
Method Development
Laboratory Facilities
Extensively equipped modern laboratory offers a wide range of facilities including:
- HPLC (UV/Vis, DAD, fluorescence) isocratic & gradient
- GCMS
- FTIR
- GC(FID)
- UV/Vis spectrophotometer
- TLC
- Viscometer
- Dissolution bath
- Karl Fischer Titrator
- Stability storage cabinets
- Chromatographic techniques
Tests offered include:
- Raw Materials Evaluation
- Active Ingredients Content
- Related Substance Content
- Impurity Content
- Uniformity of Content
- QC Release
- Certificates of Analysis
- Pharmacopoeia Testing
- Dissolution Testing
- Range of Physical Testing
- Moisture (Karl Fischer)
- Vitamin Assays
- Mineral and trace element analysis
- Veterinary Residue Analysis
- Antibiotic Assays
- Microbiology
- Storage stability trials to ICH guidelines
- Accelerated and long term stability testing
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