Analytical Development Case Studies | Velesco Pharma

Expert Solutions to Challenging Analytical Development Scenarios



Challenge: Method Development and Validation of challenging drugs


Velesco was employed to develop a Phase 3 method for drug quantitation at multiple strengths, preservative quantitation and impurity analysis from a method designed for API with co-eluting preservative related impurity peaks. This proved challenging due to difficulty with the compound and the inability to use a single point standard curve. Velesco was able to meet our client's needs and provided a Phase 3 method and validation for multiple strengths of drug product.

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Challenge: Extraction of difficult compounds


Velesco updated HPLC drug product methods to quantify API and preservative in new formulations containing excipients that were challenging to extract using the existing methods. We swiftly determined the causes of extraction inconsistencies and updated the methods to remedy the issues.

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Challenge: Large potential dose range


Method Development for multiple strengths of a difficult compound in a very large dosing range can be a challenge, but with Velesco, our clients' needs are met consistently and quickly.

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Challenge: Quick turnaround time required


Velesco applies nimblocity to develop analytical methods & formulations and perform validations, etc.

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