Blind Comparator
Stability Studies

Comparative Testing Under Controlled Conditions

Blind comparator stability studies are used to evaluate differences between a test product and its comparator over time and under ICH storage conditions.

The validity of results depends on consistent handling, precise method execution, and properly blinded workflows—making the choice of testing partner a critical factor.

BA Sciences conducts comparator studies under GMP stability protocols using validated analytical methods and controlled material management.

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Study Design and Testing Scope

We support blind comparator stability studies for formulation development, regulatory submissions, and post-approval changes. Study design accounts for packaging format, storage requirements, shelf-life targets, and origin of comparator material. 

Comparative testing includes: 

  • Dissolution testing for solid oral dosage forms
  • Assay testing for active ingredient concentration  
  • Impurity and degradation profiling
  • Appearance and identity confirmation  
  • Stability under ICH and custom conditions
  • Additional methods as required by protocol or regulatory guidance

Why Work with BA Sciences

Our stability studies team is experienced in running comparator programs that require tight control over sample handling, timing, and method reproducibility. All testing is performed in a GMP-compliant laboratory and supported by protocol-driven project oversight. 

What we offer: 

  • Controlled workflows for blinding and parallel testing 
  • Long-term and accelerated GMP stability programs under ICH stability conditions 
  • Validated methods for dissolution, assay, and impurity analysis 
  • Structured documentation to support regulatory submission and inspection readiness 

Our approach ensures that blind comparator stability studies yield consistent, audit-ready data for comparison and reporting. 

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