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Analytical Method Development and Validation

Patheon offers the full breadth of advanced analytical technologies for support of early-stage formulation for clinical trial materials. By maximizing the efficiency and flexibility for analytical and formulation development in a non-GMP environment, we are able to quickly establish a solid foundation for your product development. Our analytical development also includes:

  • IND Phase-appropriate method validation
  • Protocol driven stability studies

By having analytical method development and validation seamlessly integrated into a complete development program driven by an experienced dedicated team, Patheon is the most rapid and cost-effective way to go from molecule to market.

Method Development and Validation Studies

  • Cleaning residual assays
  • Stability indicating assays using UPLC and HPLC (including forced degradation studies)
  • Related substances, chiral purity, residual solvents analysis
  • Dissolution testing
  • Preservative assays
  • Physical methods (laser diffraction, Karl Fisher water determination)
  • Nasal spray characterization (droplet size, spray pattern, spray content uniformity)

Case Study: Reliable Analytical Method Development and Validation

The Challenge A medium-size pharmaceutical company approached Patheon to develop and validate a method for quantification of several potential genotoxic impurities (GTIs) in their drug substance. The customer’s procedure, which included a derivatization step prior to analysis, suffered from variable recovery. 

The Solution After reviewing the technical information and chemical structures, Patheon recommended a direct method based on LC/MS. A triple quadrupole LC/MS/MS procedure based on multiple reaction monitoring of parent/fragment ion pairs offered the high speed and sensitivity required for this method. 

The Outcome Patheon’s method was successfully validated over a range of 1 to 21 ng/mL for six  potential GTIs with good linearity (r ≥ 0.99) and recovery (94 to 112%).

Ask The Experts

Anil Kane, Ph.D., MBA

Anil Kane, Ph.D., MBA
Dr. Kane has more than 25 years of experience in the science and business of taking molecules throug
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Kaspar van den Dries, Ph.D.

Kaspar van den Dries, Ph.D.
Based at our Tilburg facility in the Netherlands, Dr. van den Dries leads Patheon’s European researc
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Jason Vaughn, Ph.D.

Jason Vaughn, Ph.D.
Dr. Vaughn has expertise in early and preclinical development of liquid, semi-solid and solid dosage
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Roman Hlodan, Ph.D.

Roman Hlodan, Ph.D.
Dr. Hlodan is an expert in the development of biopharmaceuticals, including analytical method devel
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Stephen Closs

Stephen Closs
Mr. Closs possess more than 23 years of experience in formulation development, tech transfer, scale-
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William E. Weiser, Ph.D.

William E. Weiser, Ph.D.
Dr. Weiser is an expert in analytical method development and validation for APIs and drug products.
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