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Integrating Solid-State Chemistry into API Process Development

You may have heard from many solid-state chemistry experts state that selecting the right solid-state form saves you money. However, have you considered what that statement means and the impact selecting the correct solid-state form has on your program? It means understanding your API and if it exhibits polymorphism and […]

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Getting Started with Chiral Method Development Part Two: Finding a CSP

In a previous blog, we discussed the concept of molecular chirality and its importance.  We also noted the ability to separate enantiomers using chiral chromatography.  In this installment, we’ll talk about the first steps in developing an HPLC method that will separate chiral compounds of interest. With any approach to […]

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Analytical Strategies from Early Development to Validation: Part Two

Phase Appropriate Analytical Method Validation Welcome to part two of our Analytical Strategies from Early Development to Validation blog series. In part one of the series, we discussed the purpose of analytical method development and validation and broke down processes for each clinical development phase. In this article, we will […]

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Analytical Strategies from Early Development to Validation: Part One

The Role of Analytical Method Development and Validation Drug development is complex and requires great care to ensure that the products we offer our patients are safe and effective. Consequently, drug development is highly regulated to ensure the appropriate controls are applied for all new chemical entities (NCEs), whether they […]

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Getting Started with Chiral Method Development

At Regis Technologies, we have a wide range of columns featuring different chiral stationary phases (CSPs), and we are often asked to recommend one that will resolve a specific set of stereoisomers.  That’s not always an easy thing to do!  But whether you’re looking to create a robust analytical method […]

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