The Institute of Pharmaceutical Innovation

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Analytical Method Development and Stability Studies

Analytical Method Development and Transfer
Our experienced analytical scientists specialise in analytical test method development for the pharmaceutical industry. We can undertake characterisation of API, known impurities and degradants using a range of standard techniques, including HPLC-UV, -DAD, -ELS , LCMS/MS, GC with FID, TCD and ECD, GCMS or more sophisticated approaches including NMR, Elemental Analysis, XRD or Raman Spectroscopy.

Typically for API’s we can develop quantitative assay and related substances methods following ICH guidelines. By performing a series of forced degradation experiments during the early method development stages we can also ensure that the test methods are stability indicating. Following successful development of an analytical method we can provide the appropriate level of validation following ICH guidelines.

At the Pharmaceutical Innovation CIC we can also transfer existing client methods to our site and the appropriate transfer protocols can be drafted internally or by the client. We ensure that the transfer is a fast and cost effective process with full reporting on completion.

Formulation Development Support
Our analytical scientists work closely with the formulation team so we can provide flexible
and speedy analytical support during the development of prototype formulations. We can
perform the following analysis on formulated products in development.

Dissolution rate and solubility studies

Homogeneity testing
% Assay and related substances testing
Excipient compatibility studies

See Preformulation Analytical Package

Stability Studies
We specialise in preclinical informal stability studies but do have the provision to
undertake a more formal ICH stability study. Typically we undertake stability testing on
API’s or formulated final products in development. Our flexible approach is vital in
early formulation development as it is important to quickly assess the stability of a
range of different formulations. We have four stability cabinets available in-house to
perform short or longer term studies using accelerated /standard plus the ability to
monitor photo-degradation. We can use a range of analytical techniques to determine
the level of degradation both chemical and physical, to determine the relative stability
of the test samples all of which are conveniently at hand. We can remove samples for
analysis at very short time intervals if necessary.