Quay Pharma has hugely experienced analytical specialists working alongside our formulation and manufacturing teams which provide expert advice and an enormous breadth of advanced analytical technologies. Their contribution is a vital factor of our success in early stage formulation development, stability studies and clinical trial manufacture.
Analytical & Quality Control Services Include:
- Analytical method transfer, development and validation.
- Stability-indicating assays using UPLC and HPLC (including forced degradation studies).
- Formal and informal stability study design, storage and testing.
- Batch release and raw material testing.
- Chemical and physical testing.
- Chiral analysis.
- Dissolution testing and drug release profiling.
- Drug substance characterisation.
- The identification and quantification of impurities.
- Comparator studies.
Our Critical Testing Procedures Provide Meticulous Quality Control Which Include:
- Testing of raw materials to ensure that each formulation component meets our quality requirements.
- In-process assays to establish that the manufacturing processes are meeting the standards set out in advance.
- Carrying out of final product assays to verify that product meets its specification.
- We employ stability testing to evaluate the useful shelf life of the product.
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