web analytics
Extraction challenges solved by our scientists with accuracy, transferability | Velesco Pharma

Analytical Method Challenge 2

Extraction of Difficult Compounds


Example 1

Velesco was contracted to develop updated HPLC drug product methods for a combination product with two low dose active pharmaceutical ingredients (APIs) and one preservative. The new formulations contained excipients that posed challenging extraction issues.


Velesco solution:

  • Typical extraction techniques were not working, so the Velesco scientists looked deeper into the literature on the physical properties of the suspected problem excipient, a surfactant.
  • It was noted that above a certain temperature, the surfactant formed super large micelles.  It was thought that the rearrangement of the micelles at that temperature could possibly be exploited to release the drug into diluent during sonication.
  • Extraction was successful, giving appropriate accuracy for the analytical methods to be validated for ongoing stability studies.


Example 2

Velesco was employed to troubleshoot and solve API extraction inconsistencies observed during stability studies for a Phase 3 drug product.


Velesco solution:

  • Velesco quickly determined the main cause for the inconsistent assay values observed and implemented straightforward solutions to provide consistent results.
  • Velesco was additionally contracted by the client to develop and validate the Phase 3 drug product release and stability-indicating methods, as well as conduct dissolution testing in support of a waiver of in vivo bioavailability and bioequivalence studies.
  • The analytical methods were successfully transferred to the drug product manufacturer.

Back to analytical development case studies

News and Events

Pace® Life Sciences Acquires Velesco Pharmaceutical Services, Expanding Capabilities in Drug Development Services

Read the Press Release!

Dave Barnes, Ph.D. CEO/CSO is a featured speaker for the webinar Topical Formulation: Selection of Excipients and Better Process Understanding for Success in Commercial Manufacturing. Webinar recording available now.

View Recording!

Newly Acquired DEA Analytical Laboratory License. We are licensed to use schedules 2, 2N, 3, 3N, 4, and 5.

In this episode of Molecule to Market, you’ll go inside the outsourcing space of the global drug development sector with Gerry Cox, Founder and Chief Operating Officer at Velesco Pharmaceutical Services.

Roundtable: M&A trends in CDMO - Molecule to Market

New Velesco Pharma clinical manufacturing facility begins operations.

Read the press release here.

Lisa Crandall, MS, and Peter Angus, PhD, spoke with Pharmaceutical Technology about the best practices in stability testing.

Read the interview here.

Velesco has expanded our analytical facilities in a new Wixom, Michigan location with the help of the Bank of Ann Arbor Technology Industry Group.

Read the press release here.

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

1 new job postings! Careers

Velesco's work published

Formulation Development & Manufacturing:
Using a Single Provider Reduces Costs & Risk
Read it here.

Follow Velesco

LinkedIn IN Icon 25px Google+ Follow VelescoPharma on Twitter FB FindUsOnFacebook 100