Product/Service

Moisture Determination of Dry Product

Moisture Determination of Dry Product

Residual product moisture content is a critical parameter when considering the stability and shelf life of lyophilized pharmaceutical product, sterile powders, or solid dosage product. Lighthouse offers complete solution for moisture determination of dry product.

Residual product moisture content is a critical parameter when considering the stability and shelf life of lyophilized pharmaceutical product, sterile powders, or solid dosage product. Moisture analysis is traditionally performed using Karl Fischer titration or thermo-gravimetric analysis (TGA) methods, which are destructive and labor & time intensive. Replacing these slow traditional methods with a rapid,  non-destructive, headspace inspection method would streamline moisture analysis efforts and help improve the quality of finished product. Studies have demonstrated that the amount of headspace water vapor directly correlates to the lyo cake moisture content.

LIGHTHOUSE offers Moisture Determination solutions for:

  • Stability testing
  • Permeation studies
  • Lyophilization cycle optimization
  • Characterizing freeze dyers for moisture distribution (moisture mapping)
  • 100% moisture inspection of commerical freeze-dried product
  • Water activity measurements of solid dosage product
  • Release testing of dry product
  • Recalls and Investigations of dry product

Our Moisture Determination solutions include:

  • Feasibility studies
  • Process and Package studies
  • Method Development
  • Method Validation Protocols
  • Automated Moisture/Pressure Lease Platforms
  • Onsite trouble shooting and support

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