USP Compliant
Tailored Analytical Testing Designed to Support Commercial Compounders
What Sets Us Apart
Stratum Analytical provides a crucial service in support of the quality control and regulatory requirements of pharmaceutical products and preparations. We have in-depth knowledge of the NAPRA standards and the specific requirements of pharmacy and commercial compounders.
Dedicated Team of Chemists & Microbiologists
Stratum Analytical possesses the extensive expertise required for developing stability-indicating analytical methods and validations. We specialize in USP compliant Stability Studies enabling safe and effective BUD assignment.
Our state-of-the-art facilities allow us to offer a wide range of laboratory analyses.
Chemical Analysis
Potency Testing (RP-HPLC and SE-HPLC)
USP Compliant Stability Studies
Stability-Indicating Method Development and Validation
Size Exclusion HPLC for protein therapeutics quality assessments
USP <791> pH
USP <911> Viscosity-Capillary Method
USP <790> Visible Particulates
USP <789> Particulate Count Test
USP <789>, <1149>, <1790> Appearance
Hazardous Wipe Sampling
Microbiological Analysis
ScanRDI Sterility Testing
ScanRDI Method Suitability
USP <71> Sterility Testing (Membrane Filtration)
USP <51> Antimicrobial Effectiveness Testing
USP <71> Sterility Testing (Direct Inoculation)
Biological Indicators
Plate Incubation/Enumeration for Environmental Monitoring
Incubation and Evaluation of Media-Filled Units
USP <71> Method Suitability
Microbial Identification
Accreditations
Contact Us Today
To learn more about our lab services, contact us today.