Analytical Method Development, Pre-inspection Analysis & Validations
To ensure successful method development there is a requirement for highly skilled analytical judgement. The 'purpose' of the method needs to be determined with some clarity and thoroughness as this will ultimately determine the long-term success of the new method. Other aspects of information relate to the actual analyte in question and 'other' materials that may be present in the analytical mix. The strategy for the method development process will result from this initial information gathering exercise. The result of this review is an objective outcome that ensures the developed method will be as 'fit for purpose' as possible, given that the requirements of the method have been sufficiently well defined.
Stability Studies require methods which are stability indicating and these methods must stand up to stringent cGMP regulations and regulatory scrutiny. Stabicon’s combination of experienced analytical team, team leaders and their cGMP training and cGMP experience will give you unmatched quality of analytical methods validated to stringent regulatory standards to meet any filling requirements.
Physical Test :
Chemical Test :
Instrumental Test :
Comparative Dissolution Profile :
Method Validation as Per ICH :
Method Development & Validation as Per ICH :
Method Transfer/ Verifications :
Further Questions :
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