Keystone Labs has a 12-year track record conducting validated testing for the global regulatory bodies, which include Health Canada and FDA. Meeting the requirements of the highly-regulated environment for production of human health products is critical to the success of your product. We set high standards in providing accurate and reliable analytical results to the Pharmaceutical, Biotechnology, Medical Device and Nutraceutical industries in the most efficient, cost-effective and timely manner.
Keystone Labs evaluates a broad range of characteristics using advanced instrumental analyses, from measuring low-levels of impurities in raw materials to determining the strength and purity of finished dosage forms. All equipment and processes conducted with Keystone Labs are part of a stringent quality system to offer the most accurate and consistent data.
Our methods follow the United States Pharmacopeia (USP) reference protocols to meet the optimal and consistent standards required for testing. In addition, we have the experience and expertise to offer Good Manufacturing Practices (GMP) quality and compliance.
Keystone Labs is committed to providing the best analytical service, with complete assurance of data quality, reliability and validity.
Keystone Laboratories offers an extensive array of analytical services to customers with diverse requirements:
- Gas Chromatography (GC) Analysis
- High Performance Liquid Chromatography (HPLC) Analysis
- Raw Material Testing
- Total Protein Assays
- Total Organic Carbon analysis – low level of detection
- Nitrates and Heavy Metal analysis
- Conductivity and pH analysis
- Loss on Drying
- Melting Point/Boiling Point
- Identity, purity and quality of raw materials using compendia or client supplied methods
Whether your company needs full development, support services or consultation, Keystone Labs can provide the quality expertise your company needs.