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Pace Analytical

1311 Helmo Ave N.

Oakdale, MN 55128 US


Pace Analytical Services:

Contract Analytical Laboratory Services

Pharmaceuticals
- Raw Materials Testing
- Finished Product Testing
- Stability Storage & Testing - ICH Stability Storage, Photostability & Custom Conditions
- Method Development / Validation

Microbiology
- Environmental Monitoring
- Bioburden Testing
- Sterility Testing
- Purified Water Systems
- Microbial Limits
- Antimicrobial Efficacy (AET / PET)
- Microbial Identifications (Ribotyping)

Medical Devices
- Extractable / Leachable Studies
- Elution / Dissolution Studies
- Chemical Characterization of Materials (ISO 10993-18)
- Residual Chemical Analysis (Cleaning verification)
- Physical and Functional Testing
- Accelerated Aging Studies

Raw Material Testing
- Formulation Excipients
- Active Pharmaceutical Ingredients (API)
- Compendia Methods (USP/EP/BP/JP/FCC/ACS)
- Certificate of Analysis Verification
- Vendor Qualification Program Support

Process Validation & Facility Monitoring Services
- Process Water Systems (Purified Water, WFI & Clean Steam)
- Compressed Air & Compressed Gas Systems
- Cleaning Verification / Validation Studies
- On-Site Sampling

Finished Products & Packaged Goods
- Content Uniformity & Potency Assay
- Dissolution
- Impurity / Degradation Products Assay
- Quality Control Release Testing
- Formulation Stability

Research & Development
- Analytical Method Development
- Analytical Method Validation
- Remedial / Retrospective Method Validation