R&D Analytical Services

R&D Analytical Services

SOLUTIONS TAILORED TO YOUR SPECIFIC PROJECT NEEDS

Extractables & Leachables Studies

Neopharm Labs offers extractables & leachables studies designed by our Scientists to meet unique and diverse project requirements. Our R&D team is composed of pharmaceutical industry experts who conduct impurity profiling of drug products, from early stage isolation, purification and characterization to the investigation of foreign substances in commercialized products.

  • Our GMP compliant laboratory focuses only on pharmaceutical industry requirements
  • We design E&L studies protocols customized to you project that respect USP <1663> and <1664>
  • Our R&D experts support the E&L study itself and special investigations

We also have the capacity to isolate and purify any foreign substances (process impurity, degradation product, leachable, etc.) found in your drug substances or drug products.  A small amount of the purified material is used for a complete characterization of the impurity (accurate mass measurement, mass spectrum, NMR).  The remaining quantity can be used to validate this impurity in your related substances analytical method within our GMP laboratory approved by both FDA and Health Canada authorities.

Purification & Chiral Separation

Our lab has multiple highly customized preparative chromatography systems that allow us to achieve fast turnaround and high recovery without sacrificing quality.  Upon completion of a purification project, clients receive highly pure material, fully optimized methods, and detailed reporting to support ongoing preclinical development.

Impurity Isolation & Profiling

Impurity isolation, profiling, and identification offers critical information at any stage of process development or manufacturing. Our laboratory is capable of screening/profiling assays using accurate mass MS or of isolation and specific structure assignment, supporting CMC documentation and ongoing development of synthesis, scale-up, and production.

Analytical Method Development

Our scientists develop analytical methods that are robust, transferable and reproducible, and designed to generate quality results.  We focus on methods that are fit for purpose and on tech transfer – we recognize that you work with many partners, and we work to develop methods that are easy to use and deploy.

Preformulation & Custom Assays

  • Solubility Profiling in vehicle or buffers
  • Solubility Excipient Screening
  • Stability Indicating Method
  • Customized physical properties assays
  • Overall Stability
  • Forced (Stress) Degradation
  • PSA – Indirect Measurement Through EPSA

We help late stage lead development teams understand the physiochemical properties of their lead compound.  The panel includes 5 components, resulting in a matrix of over 150 experiments.  This provides you with the most soluble and stable environment for your compound.