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Pharmaceutical Analysis Services From Gateway Analytical

Our FDA-inspected labs help to ensure our results are reproducible and our analyses are accurate. We have experience with every step of a drug product's market journey, with the ability to answer questions about drug development, transportation and handling, and manufacturing inconsistencies.

Pharmaceutical Analysis Process Infographic

USP <788> and USP <789> are standard, validated methods for analyzing foreign particles within injectable and ophthalmic pharmaceutical products.

USP <788> and USP <789>

The presence of foreign materials within injectable and ophthalmic drug products can have significant effects on product quality and safety. USP<788> and USP <789> are required tests for the release of injectable and ophthalmic drug products, respectively. We provide standard testing for compendial methods of USP <788> and USP <789> that allow our customers to understand the number and size of foreign particles within their injectable and ophthalmic drug products.

Gateway Analytical offers both Method 1 (LO) and Method 2 (MM) for these compendial methods.

  • Method 1 is an automated method performed using light obscuration to objectively count and size particles with a HIAC.
  • Method 2 is a manual method performed using microscopic techniques. This is performed when Method 1 either fails or is infeasible.

We provide our customers with data formats that both comply with USP methods and are easy to read and understand.

Contact us today to learn how our FDA-inspected facilities can meet your analytical needs.