State-of-the-Art Testing

Kirkman^® Products Are Tested Using State-of-the-Art Technologies

Kirkman's Ultra Tested^® process uses highly equipped, state-of-the-art, independent laboratories that have been carefully selected based on their excellent reputations for nutraceutical testing, and all labs must be ISO 17025 certified. Kirkman uses many laboratories for the specialized services they offer because no one lab could run all the assays we require. Only the most advanced and accepted methods and procedures for the Ultra Tested protocol are employed. The laboratory equipment used is the most advanced state-of-the-art equipment available, including mass spectrometers for heavy metals testing. These tests can yield results down to parts per billion.

Raw Material Identity

Raw material identity is verified through 3^rd party labs using a variety of testing, including: HPTLC, HPLC, FTIR, ICP-MS and ICP-OES.

Heavy Metal Analysis

Heavy metal analyses of raw materials and finished products are performed by state-of-the-art Inductively Coupled Plasma-Mass Spectrometer (ICP-MS) equipment that offers microanalysis of heavy metal contamination. Results can be obtained in parts per billion on all materials. This type of equipment is the only accepted type of laboratory equipment for complying with California's Proposition 65 heavy metal specifications. Sample preparation for the ICP-MS is performed using advanced technology microwave digestion.

Allergy Testing

Kirkman strives to source 100% allergen free ingredients, but when allergen testing of Kirkman products is needed, there are 2 allergen tests that may be used:

• The 3M Rapid Allergen Protein test - a qualitative immunochromatographic assay for rapid monitoring of specific food allergens which was designed for accurate detection of processed and unprocessed allergen proteins.
• ELISA methodology, enzyme-linked immunosorbent assay, a quantitative test that is sensitive down to parts per million, depending on the allergen.

Pesticide Testing

Kirkman monitors all botanicals, and raw materials derived from botanical/herbal sources, for potentially harmful pesticides.

Pesticide residues fall into two categories: non-volatile and volatile. To monitor all types of potential pesticide contamination, therefore, requires two distinct types of laboratory equipment. The non-volatile pesticides are detected and measured with liquid chromatography (LC). Non-volatile pesticides are tested on state-of-the-art LC triple quadrupole spectrometer (LC-MS) equipment. By using the new triple quadrupole technology, a tenfold increase in sensitivity is realized compared to older single quad technology. LC-MS is also used to test for non-volatile chemicals, vitamins, and other compounds for dietary and food supplements.

The assay measurements of volatile pesticides and other volatile chemicals and contaminants require different technology. Kirkman uses state-of-the-art custom gas chromatograph (GC) equipment for this purpose, equipped with a pesticide GC-MS analyzer. This is the most advanced technology available for the analysis of volatile pesticide compounds.

Label Claim Verifications and Stability Testing

Label claim verifications and ongoing stability studies of Kirkman's products are performed using the Food and Drug Administration (FDA), United States Pharmacopeia (USP), Food Chemical Codex, or equivalent Association of Official Analytical Collaboration (AOAC) methodology. In the case of contaminants regulated separately by the State of California under Proposition 65, Kirkman follows California's recommended testing procedures, which usually are even more stringent than the FDA's or USP's.

Microbiological Testing

Kirkman also monitors raw materials and finished products for the presence of microbiological contamination, yeast, and mold growth. Stringent limits are in place to monitor aerobic bacterial plate counts, yeast and mold counts, and the continuous absence of problematic bacteria which may include E. coli, Pseudomonas, Bile Tolerant or Enterobacteriaceae, Coliforms, Salmonella, Staphylococcus aureus, and Listeria. Testing methods utilized for this microbiological testing are derived from the FEDA's Bacteriological Analytical Manual, the USP or the AOAC.

Kirkman's Quality Assurance

Kirkman has a Quality Assurance department that is devoted to ensuring that the laboratories we use are well qualified and certified; use the most current and best testing procedures; and test with the most up-to-date equipment for effective, accurate results.