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API and Finished Product

ICH Q2(R1) is considered the primary reference for recommendations and definitions on validation characteristics for analytical procedures.

Tepnel’s GMP laboratories based in Livingston, Scotland have provided over 20 years of quality control analytical testing in support of active pharmaceutical ingredients (API), in-process testing and finished products on a wide variety of dosage forms of small molecules for all phases of the drug development process.

Utilising Waters HPLC, UPLC and the Waters H-Class HPLC method development platform, we adopt a flexible and customisable approach to developing and validation of methods that are fit for purpose across the spectrum of available detection technologies. Our scientists have developed and validated methodology for active ingredient quantitation, related substances quantitation, stability indicating, dissolution applications including other routine quality control applications and across a range of separation and quantitation technologies.

Method development experience at Tepnel includes:

 

Sections in Method Development and Validation

All Method Development and Validation

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