Pharmaceutical
The facilities are staffed by qualified chemists, are equipped to provide you with a full analytical service.
The following techniques are available but not exhaustive, include all method developments and bespoke procedures.
QC Analytical Testing |
CMC Support |
Consulting Services |
Residue Testing |
Routine / Non Routine |
Method Development |
Validation Protocol Development |
Chemical Analysis |
Batch Release |
ICH Method Validation |
GMP / mock PAI Inspections |
Microbial Analysis |
Raw Material |
Technology Transfer |
Technology Transfer |
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Drug Substance |
Report Writing |
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• Excipient |
Process Validation Testing |
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• Comparison Studies |
Cleaning Validation |
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Product Testing |
ICH Stability Testing |
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ICH Stability |
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• Shelf Life |
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• Accelerated |
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• Regression Analysis |
Tests
Physical properties: Appearance, mean weight, fill weight, hardness, disintegration, dimensions, loss on drying, friability.
Identification:
Our comprehensive range of equipment allows us to work with the wide range of techniques called for in different test methods and monographs, by standard and bespoke procedures
Dissolution:
USP and EP methods are available. Single time point, or sustained release. Water, or simulated gastric/intestinal fluid.
Assay:
UV, HPLC, or titration. Single or multiple component products can be tested to current monographs or your own validated methods.
Impurities / Related substances:
From TLC to multi-wavelength gradient HPLC.
Stability Trials:
Long term, and accelerated testing is available in accordance with ICH guidelines.
For more information on the above or any QC/QP related items please call (0)115 912 4265 for a confidential discussion.
Equipment
High Performance Liquid Chromatography:
tests for active ingredients / excipients, and the quantification / profiling of excipients etc
Capillary Gas Chromatography:
Also includes a headspace GC.
Dissolution:
The dissolution baths are complemented by a media preparation system, enabling increased throughput when working with degassed media.
UV/Vis Spectrophotometry:
Stand-alone UV/Vis spectrophotometers enable multiple products to be analysed simultaneously.
Infra-red Spectrophotometry:
Our FTIR is fitted with a Specac ‘Golden Gate’, allowing increased sample throughput, due to reduced sample preparation time.
Physical Testing:
Tests are available for the physical testing of capsules and tablets.
> Friability
> Disintegration
> Hardness
Services
> Method Development and Validation
> Raw Material Testing
> Finished Product Testing and Release
For more information on the above or any QC/QP related items please call (0)115 912 4265 for a confidential discussion.