Tests and Methodologies

Pesticide Screening by The National Food Laboratory Inc.

The National Food Laboratory Inc (The NFL) utilizes the FDA published "Luke Method" to screen for pesticides. Each herb sample is taken through a rigorous extraction and concentration procedure. This concentrate is then analyzed using the specific compound detector for each pesticide family, referencing against pure pesticide reference standards. The specific compound detectors are as follows:

• Flame Photometric for organophosphates, referencing against pure organophosphate reference standards.
• Nitrogen Phosphorus for organonitrogen, referencing against pure organonitrogen reference standards.
• Electron Capture for Organochlorinated compounds, referencing against pure organochloride reference standards.
• High Performance Liquid Chromatography for N-Methyl Carbamates, referencing against pure N-Methyl Carbamate reference standards.

Heavy Metal Screening by The Toxicology Group, LLC, a wholly owned company of NSF International

Each herb sample is analyzed for heavy metals, with state of the art analytical technologies, following US EPA Standard Methods and AOAC protocols. NSF prepares each herb sample by microwave assisted acid digestion and then performs each analysis based on US EPA method 200.8 - Determination of Trace Elements in Waters and Wastes by Inductively Coupled Plasma – Mass Spectrometry (ICP-MS). This methodology allows for rapid scanning, with low detection levels and screens for arsenic, cadmium, mercury, and lead.

Microbiological Testing, including Total Plate Count, E. coli, Yeast and Mold, Staphylococcus, and Salmonella by the in-house laboratory. Validation by The National Food Laboratory Inc. (NFL)

• Total Plate Count, E. coli and Yeast and Mold testing follows stringent cGMP protocol and uses AOAC (Association of Analytical Communities), AFNOR (France & Europe), Health Protection Branch, and Compendium of Analytical Methods (Canada) recognized ready to use 3M Petri film plates. 3M Petri film plates are made at an ISO 9002 certified site.
  
  Our laboratory tests for Total Plate Count, E. coli, yeast and mold. Tests are validated by NFL, following FDA BAM methodology.
• Salmonella - Our laboratory uses Hardy Diagnostic's USP and European Pharmacopoeia-recommended Eylose Lysine Deoxycholate (XLD) Agar as a medium for isolating Salmonella species.
  
  Testing results are validated by NFL following the FDA BAM Vidas method.

Aristolochic Acid Detection testing by Exygen Research

Exygen Research's premier Aristolochic Acid Detection service is conducted under stringent US, FDA current Good Manufacturing Practices (cGMPs).

Exygen follows the protocol of US, FDA Laboratory Information Bulletin 4212 (Flurer et al., 2000) to detect the presence or absence of trace levels of Aristolochic acid in products. Aristolochic acid is extracted from the sample matrix with methanol: formic acid. The analysis is conducted with a quantitative aliquot of extraction fluid. Exygen uses FDA method LIB 4212, which includes a Liquid Chromatography-Tandem Mass Spectrometry (LC-MS/MS) confirmatory method, for the analysis and quantitation of Aristolochic acid. This method is currently being validated by AOAC (Association of Analytical Communities).

Testing Materials used by the in-house laboratory are supplied by:

3M
Providing USP and AOAC approved testing materials 3M Petri film TPC, 3M Petri film EC, and 3M Petri film Y.M.

3M Center, Building 0275-05-W-04
St. Paul, MN 55144
Tel: 800 328-6553
www.3m.com/microbiology/home/products/petrifilm/pp_over.html

Hardy Diagnostics
Providing BAIRD-PARKER AGAR and XLD AGAR

1430 W. McCoy Lane
Santa Maria, CA 93455
www.hardydiagnostics.com