Analytical Testing Services for Particle Analysis

Gateway Analytical particle analysis services provide customers with a chemically-specific understanding of the active pharmaceutical ingredient (API) and excipient particles within a formulation. This information is then used to determine particle size, shape, aggregation, and dispersion characteristics. We utilize this data to create in-depth analysis reports for our customers, which provide critical insight for nasal, inhalation, semi-solid, transdermal and solid dosage drug products.

Particle Analysis Services Contamination Investigation Services
  • Particle size distribution (PSD) measurement
  • Particle shape measurement
  • Chemically-specific analysis of agglomerates
  • Assessment of agglomerates effect on PSD measurements
  • Characterization of polymorphs
  • Wear debris testing of medical devices
  • Identification of foreign particulate matter
  • Characterization of drug phase (dissolved or precipitated)
  • Measurement of drug PSD over time as part of stability testing support
  • Localization of drug and excipient materials
  • Content uniformity of drug materials
  • Foreign Particulate Matter Identification
  • Nonconformance Issues
  • OOS Investigations
  • Particle Contamination Characterization
  • Contamination Source Determination
  • Product Return Analysis
  • Counterfeit Drug Investigation
  • Failure and root cause analysis
  • FDA Critical Path Opportunity for direct measurement of particle size equivalence in nasal spray suspensions
  • Support of patent infringement litigation
  • Method development and validation protocol
  • Support and guidance for companies going through bioequivalence

Request a Service

Gateway Analytical works closely with our customers to provide the most accurate data results and time effective analytical testing services possible. If you are interested in our particle analysis services, please contact us by filling out the short form.