Analytical Sciences

Experts in analytical method development for topical formulations.

Specialists in Analytical Method Development for Topical Formulations

Our goal for your product is a stable, elegant formulation that penetrates as desired for your target disease. Analytical chemists are an integral part of each team assigned to a formulation development project. They develop and validate the stability-indicating and impurity-tracking analytical methods which are required. Due to the large number and variety of excipients often used, topical products require specific expertise as compared to other dosage forms. Because we work exclusively on topical products, some with multiple APIs, with very low levels of API, and some with the drug suspended rather than dissolved, our scientists have this expertise. At Dow we handle these challenges on a regular basis.

Large Bio-Molecule Analytical Expertise

Dow has significant experience with incorporation of peptides, proteins and oligonucleotides into topical formulations. Consequently, we have a separate team of method development experts to handle these challenging projects. We have developed efficient sample preparation procedures coupled with a wide range of separation techniques – e.g., spectroscopic (UV), chromatographic (HPLC, SEC), traditional activity and plate assays.

Quality Facilities, Equipment and Staff

Dow's GMP laboratory facility is state-of-the-art. Testing is performed using well-maintained, up-to-date analytical equipment that is stringently evaluated with our IQ/OQ/PQ protocols and calibration programs. Most importantly, Dow provides a professional, highly competent, trained staff to serve your analytical testing needs.

Pharmaceutical Analysis Services

  • Method Development/Validation (USP/ICH)
  • Potency / Impurity Assays
  • Compendial Testing (USP/NF)
  • Dissolution Testing
  • Stability Testing — Accelerated and Long-term (ICH)
  • Photostability Studies (ICH)
  • Physical and Chemical Measurements
  • In Vitro Release (SUPAC)
  • Process Validation Support
  • CMC/Regulatory Support

To Learn More

Please contact Steve Smith, Vice President of Business Development (X 672) or Charles G. Chavdarian Ph.D., Senior Director of Analytical Sciences, for additional information. We encourage you to visit our facilities and evaluate our operations. Tel: 707.793.2600

Get more information about Stability Services