A person wearing gloves holds a small vial near a headspace analyzer labeled

Water Activity Determination

Controlling water activity is essential for maintaining potency, purity, and safety in oral solid dosage (OSD) products. With USP <922>, manufacturers are now adopting water activity measurements during formulation, packaging development, and stability testing.

LIGHTHOUSE water activity measurements are

  • A direct measurement of reactive water
  • Providing direct insight into product stability
  • Unaffected by other volatiles
  • Free from "moisture memory" from prior samples

Measure reactive water directly with headspace water activity analysis

USP <922> defines water activity (aw) as the free, unbound water available to fuel unwanted chemical, physical, or biological reactions.

Unlike total water content, water activity directly correlates to critical quality attributes of tablets and capsules.

Monitoring it throughout the product lifecycle ensures control over attributes like microbial growth, degradation, dissolution, and hardness, using non-destructive headspace analysis for precise data.

 

A LIGHTHOUSE headspace water activity analyzer on a countertop, with vials and other primary packaging in the foreground.

Selecting the right primary package for your product

Non-destructive headspace analysis can be used to assess a primary package’s ability to maintain low water activity throughout its shelf life, ensuring product quality up to expiration.

LIGHTHOUSE supports development studies to help you select the most effective packaging for long-term product stability.

 

 

A small clear vial containing a oral solid dosage product ready for measurement of its water activity levels.

Water activity as a direct measure for product quality

Water activity directly impacts the stability and quality of dry pharmaceutical products.

Determining water activity offers valuable insights into how environmental factors like temperature and humidity affect key characteristics such as powder flow, compression, and adhesion.

Moreover, water activity is key to minimizing microbial risk in dry pharmaceuticals. According to USP <1112>, controlling water activity reduces the need for frequent microbial testing.

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