A Guide to Analytical Method Development: Part 1

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Early Step by Step Questions to Ask

  • Step I: What type of product/analyte is being tested?
  • Step II: What is the intended purpose of the method?
  • Step III: What type of method should I use?
  • Step IV: What components will effect my method?

Development Phase

Step I: Product/Analyte

What type of product/analyte is being tested?

  • Small or large molecules (proteins/peptides).
  • Raw materials.
  • Intermediates/in-process or finished products.

What is the sample composition?

  • Sample matrix.
  • Target concentration.

Step II: Method Propose

What is the intended purpose of the method? 

  • Quantitate, detect, identify, purify, characterize.

Will the method be used for:

  • Intermediate/release/stability testing.
  • Characterization, formulation, or degradation studies.
  • Reference standard qualification.
  • Potency, excipient, or impurity testing.

Step III: Method Selection

What type of method should I use? 

  • Compendial: Standardized Methods (United States Pharmacopeia/National Formulary) or FDA recognized procedures. Requires verification.
  • Non-compendial: Method which requires full development and validaiton.
  • Literature research

Step IV: Method Components

What components will effect my method?

  • Instrumentation selection.
  • Reagent/solution/diluent selection.
  • Reference standard and control selection.
  • Instrument and operation parameter set-up.
  • System suitability.
  • Test sample used.

Establishing conditions, setting operations parameters, and challenging method performance properties must be measured. This is the QUALIFICATION PHASE!

It can be tough to define each step of the development stage of your drug, but the experts at Pharmatech Associates are here to help. Contact us today!

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