Analytical Development Case Studies | Velesco Pharma

Expert Solutions to Challenging Analytical Development Scenarios

 

 

Challenge: method development and validation for a challenging drug product

 

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 an active pharmaceutical ingredient (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 HPLC method and HPLC method 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 pharmaceutical formulations containing excipients that were challenging to extract using the existing methods. We swiftly determined the causes of extraction inconsistencies and updated the analytical methods to remedy the issues.

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Challenge: large potential dose range

 

Analytical 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 and formulations for clients - reflecting Velesco's commitment to be responsive, accommodating and eager to help clients reach the full potential of their compound, quickly and efficiently.

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nimblocity reflects Velesco Pharmaceutical Services' commitment to be responsive, accommodating and eager to help you reach the full potential of your compound, quickly and efficiently

News and Events

CEO Dave Barnes has been published in a new Pharmoutsourcing article on Clinical Trial Materials and Manufacturing

  

2 new job postings! Careers 

  

Velesco will be at AAPS PharmSci360 in November in Washington, DC!

Come visit us at booth #2415!

  

Velesco has been awarded a subcontract for analytical method development, manufacturing clinical supplies, and testing the stability of an investigational drug for the treatment of Beta-Thalassemia through the NCATS! Read the press release here.

  

We celebrated our 10th anniversary in 2017!

  

Velesco's work published in

a Drug Development & Delivery article!

Read it here.

  

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