Sector: Food & Drink
James Hutton Limited is home to Mylnefield Lipid Analysis, a specialist lipid laboratory established at the James Hutton Institute in 1995 by Bill Christie and Frank Gunstone, renowned lipid analysis experts.
The current laboratory team has more than 20 years' experience of analysing oils and fats. The laboratory has been inspected by the Medical and Healthcare products Regulatory Authority (MHRA) and is approved for analysing lipids from clinical trials to Good Clinical Practice (GCP) standards. It has also been inspected by the Food and Drug Administration (FDA) and it is approved by the FDA and MHRA for the analysis of lipid-based pharmaceutical and nutraceutical products to Good Manufacturing Practice (GMP) standards.
Mylnefield Lipid Analysis is one of very few organisations in the world that has this double accreditation. In addition the team has expertise in the extraction of lipids from complex matrices, stability testing and the analysis of omega-3 fatty acids, phospholipids and other complex lipids.
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Lipid analysis can be used for:
- The food and drink sector - lipids in the form of oils and fats have a pivotal effect on the taste, stability, mouthfeel and nutritional content of an enormous range of products
- Food supplements and nutriceuticals, from omega-3 oils to antioxidants
- The healthcare and pharmaceutical sector - lipids are essential for diagnosing disease, delivering innovative new treatments and developing new and efficient methods for applying those treatments to the patient
- Fuels, lubricants, insulators for the electricity industry and raw materials for producing biodegradable materials
- Omega 3 analysis – an area of specialty for Mylnefield Lipid Analysis
For further details of all analysis and to contact Mylnefield Lipid Analysis, please visit www.lipid.co.uk
Stability Testing and Stability Storage
Mylnefield Lipid Analysis provide a full complement of state-of-the-art cGMP stability storage and analytical testing resources and expertise to support commercial stability studies, release testing and quality control analyses for active pharmaceutical ingredients and drug products in virtually all dosage forms and delivery systems.
Stability Storage Conditions Available:
25°C/ 60%RH (± 2°C/±5%RH) - Real time storage
40°C/ 75%RH (± 2°C/±5%RH) - Accelerated storage
GMP stability storage solutions include:
Stability storage at typical ICH conditions for API and finished product
Customized stability storage
Accelerated stress studies at high temperature and humidity
fully mapped stability chambers
24-Hour continuous monitoring and recording of conditions
Back-up power to stability chambers and monitoring system
Controlled access facility
Stability study protocol development
Sample management during study
In-house analytical testing and technical support throughout the stability study
Dispatch to testing sites for subcontracted analytical testing
Mylnefield Lipid Analysis can write the stability storage protocol for approval by the customer before commencing the study, or alternatively Mylnefield Lipid Analysis can follow the customers own protocol.
Please contact Claire Traynor to discuss any stability study requirements.