Ash Stevens Analytical Support

Analytical Support

Ash Stevens has a dedicated and experienced analytical department providing comprehensive support from early-stage development to commercial API manufacturing.

We understand the importance of high quality and timely analytical support to the success of a drug development program. Our approach is to optimize for success by maintaining a high ratio of analytical support staff to chemists and engineers on every project. Ash Stevens has over 50 years of experience providing broad analytical support for a wide-range of chemistries, developing and validating analytical methods using state-of-the-art technologies and instrumentation.

Analytical Capabilities Include:

  • Methods development
  • Methods validation
  • Specification development / material testing
  • Structural analysis
  • Impurity isolation and identification (including GTIs)
  • Product characterization and purity assessment (HPLC, GC, GC/MS, LC/MS, Heavy Metals, Karl Fischer)
  • ICH stability studies (storage and testing)
  • Reference standard qualification and maintenance
  • API solids characterization
  • Cleaning method development and validation
  • Test and release of starting materials, intermediates and final products
  • Impurity profiling

High Potency APIs (HPAPIs)

Ash Stevens is a leader in the development and cGMP manufacture of high potency active pharmaceutical ingredients (HPAPIs).

Regulatory Compliance & Support

Ash Stevens is a fully cGMP-compliant operation offering regulatory support spanning early-stage drug substance development through NDA registration and post-approval manufacturing.