Dietary Supplement, Nutraceuticals and Natural Health Products Portfolio of Services

March 2012

CONTENTS Introduction. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 Nutritional Analyses . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 A. Product Safety Risk Assessment. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Carbohydrates. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Lipids. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Minerals . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Proteins. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Proximates . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Vitamins . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

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Probiotics. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 Quantitative Testing. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4

Identification Technologies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 Additives & Technological Enhancements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 Antioxidants . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Coloring Agent. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Flavors. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Preservatives and Acidifiers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Sweetners. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

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Bioactives and Plant Extract Analyses. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 Contaminant Analyses . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8 Allergens. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Heavy Metals. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Mycotoxins . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Pesticides. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Other Contaminants . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

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Microbiology Analyses . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8 Qualitative. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8 Quantitative. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8

Stability Studies. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9 What is a stability study? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . What are the advantages of stability study? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Objectives: . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . History:. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Study duration: . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Other studies to determine shelf life: . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

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Nutritional Clinical Studies. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10 Services Performed Outside North America Genetically Modified Organisms (GMO) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11 Mixed Bacterial Species by dHPLC. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11 Diversity of Complex Flora Analysed by dHPLC. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Applications. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Target Products. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Advantages. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

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The entire content of this Catalog is subject to copyright protection. Copyright © 2011 Silliker, Inc. All rights reserved. The contents of this Catalog may not be copied other than for use by non-for-profit organization, and appropriate reference with all copyright notices stated. The Catalog may not be copied, reproduced or otherwise redistributed. Except as expressly provided above, copying, displaying, downloading, distributing, modifying, reproducing, republishing or retransmitting any information, text or documents contained in this Catalog or any portion thereof in any electronic medium or in hard copy, or creating any derivative work based on such documents, is prohibited without the express written consent of Silliker, Inc. Nothing contained herein shall be construed as conferring by implication, estoppel or otherwise any license or right under any copyright of Silliker, Inc., or any party affiliated with Silliker, Inc.

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About Silliker For over 40 years, Silliker has championed quality systems and results that are documentable and reproducible. Our commitment to operational excellence helps our valued clients protect brand image, ensure timely delivery of products that match customer requirements, and meet exacting specifications for quality and safety. As a pioneer in the analysis of dietary supplements, Silliker is a trusted and innovative partner of dietary supplement companies around the globe. This booklet provides an overview of our expert services, which we are continously expanding to meet the needs of our customers. Employing the latest methodologies and cutting-edge technologies, our extensive analytical services meet recognized standards, such as United States Pharmacopeia (USP) and Food Chemical Codex (FCC). Throughout our operations, we utilize validated and official methods of AOAC INTERNATIONAL, AOCS, USDA, AACC, and other recognized bodies to ensure the delivery of accurate, reliable and acceptable data. Our operations are highly skilled in the detection and identification of microbial, chemical, and physical contaminants. As part of our services, Silliker method development specialists can modify existing client

www.silliker.com Silliker delivers uniform and precise testing results that are recognized worldwide. At our dedicated dietary supplement centers in North America and Europe, our scope of services include: In addition to our extensive microbiology and chemistry expertise, we offer human clinical trials and stability studies to support your product development needs. We also provide label claim

support with full testing documentation and nutritional labeling. Our application expertise includes dietary supplements, functional foods, nutraceuticals and nutritional beverages.

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proprietary assays to corroborate product label claims or stated specifications. Globally, dietary supplement companies are charged with integrating science-based strategies and programs into a comprehensive safety program to assure product safety and quality. Silliker professionals understand your challenges and can help you implement an integrated program to maximize safety and safeguard your brand. Whether you’re launching a new product or conducting a clinical trial, Silliker professionals can assist you. Accredited to ISO 17025, an internationally recognized benchmark of technical and managerial excellence, our laboratories are reinforced by an extensive quality system that incorporates internal control samples, external control matrices, and reputable proficiency programs. We dedicate ourselves to meeting and exceeding the expectations of our valued clients. The success of your quality assurance program largely depends on your continuous commitment to quality. Leading companies worldwide recognize Silliker as a trusted partner due to our ability to deliver accurate information in a timely manner, our reputation as a scientific leader, and our local and international presence.

Dietary Supplements • Chemistry   Heavy Metals   Economic Adulterants   Pesticides / Drug Residues

 

  Allergens

• Microbiological   Pathogens   Probiotics

• Identity Testing • Assay / Potency Testing • Stability Studies / Shelf-life • Nutritional Analyses • Clinical Trials • cGMP Consulting 3

Nutritional Analyses Carbohydrates Beta-glucan D3-D10 Dextrose Easily assimilated carbohydrates Fructooligosaccharides Fructose Galactose Glucose Non-soluble fibres Inulin Lactose Malto-dextrin Maltose Maltotriose Raffinose Rhamnose Saccrose Soluble fiber Starch Total carbohydrates Total fiber Total sugars

Lipids Acid value Cholesterol CLA EPA/DHA Fat acidity Fatty acids Free fatty acids Insoluble impurities in hexane Iodine value Melting point

Monounsatured fatty acids Omega-3 and -6 fatty acids Peroxide value Phytosterol + / - Polarized compound Polyunsatured fatty acid Saponification value Saturated fatty acid Smoke point Total sterol Trans fatty acid Unsaponifiable matter Wax

Minerals Ashes Cadmium Calcium Chorids Chromium Cobalt Copper Iodine Iron Lead Magnesium Manganese Mercury Phosphorus Potassium Sodium Total sulphur Zinc

Proteins 5-hydroxytryptophan Ammonia Ammonia nitrogen

Probiotics Quantitative Testing As your R&D partner, the Silliker Food Science Center can help you identify potential quality and safety issues prior to product launch. Silliker can provide independent third party validation of probiotic viability and stability through the product’s expiration date. Common enumeration tests include total viable count, Bifidobacterium count, and Lactobacillus count. The total viable count reports all live bacteria regardless of genus. The Bifidobacterium and Lactobacillus results are reported at the genus level regardless of species. 4

Collagen (l-hydroxyproline) Creatinine Free amino acid Gamma-aminobutyric acid N-acetylcysteine N-acetyltyrosine Nitrate Nitrite Protein Soluble proteins Taurine Total amino acid Total nitrogen Total nitrogen matter Total protein Total volatile basic nitrogen Tryptophan Urea Whey protein nitrogen

Proximates Ash Calcium Dry matter Easily assimilated carbohydrates Fat Magnesium Moisture Nutritional value Phosphorus Potassium Protein Sodium Total carbohydrates Total fiber Vitamin B1 (Thiamin) Vitamin B12 (Riboflavin)

Vitamin B2 Vitamin B3 or PP Vitamin B5 Vitamin B6 (Pyridoxine) Vitamin B9 Vitamin C Vitamin H or B8 Vitamin K1 Vitamin K3 Vitamin P Vitamin A Zinc

Vitamins Ascorbyl palmitate Beta-carotene Para-amino benzoic acid Vitamin A Vitamin B1 (thiamin) Vitamin B12 Vitamin B2 (riboflavin) Vitamin B3 or PP (nicotinamide and niacin) Vitamin B4 (choline) Vitamin B5 (pantothenic acid) Vitamin B6 (pyridoxine hydrochloride) Vitamin B9 (folic acid) Vitamin C (L-ascorbic acid) Vitamin D2 (calciferol) Vitamin D3 (cholecalciferol) Vitamin E Vitamin H or B8 (biotin) Vitamin K1 Vitamin K2-7 Vitamin K3 Vitamin P (rutin)

Identification Technologies Through its “Microbial Identification Program,” the Silliker Food Science Center can provide you with accurate and reliable source tracking services utilizing state-of-the-art technologies. These services offer a reliable tool for strain differentiation and comparison. uuGene Sequencing Gene sequencing is considered the “gold standard” for microbial identification. The main benefit of this technology over traditional phenotypic methods is the ability to quickly generate accurate and reproducible results at the genus and species level. This saves time and money during product development when rapid definitive results are needed. uuRep-PCR by DiversiLab Repetitive sequence based – Polymerase Chain Reaction (Rep-PCR) allows verification of the probiotic strain integrity over time, which provides scientific substantiation for any strain associated label claims. An initial probiotic sample

is analyzed via Rep-PCR to get a DNA fingerprint master, which is stored in a database. Fingerprints of subsequent samples are compared against the master sample to determine production lot acceptance or rejection. uudHPLC The denatured High Performance Liquid Chromatography (dHPLC) is a new tool for DNA fragment analysis of mixed bacterial species in various environments. This high speed, high resolution, and automated technology can detect polymorphism in DNA, allowing differentiation between similar probiotic strains. The dHPLC method offers the ability to determine the population dynamics of microbial communities without a culture step. In yogurt, for example, this application allows users to track the probiotic population dynamics throughout the product’s shelf life.

Additive and Technological Enhancements Antioxidants

Coloring Agent

Ascorbic acid Butylated hydroxyanisole Butylated hydroxytoluene Dodecyl gallate Erythorbic acid Octyl gallate Propyl gallate Tocopherols (a, g, s) Vitamin E (alpha tocopherol)

Allura red AC Amaranth Anthocyanin Astaxanthin Azorubine Beta-carotene Betanin Bixin Brilliant blue FCF Canthaxanthin Capsanthine Carminic acid Erythrosin Indigo carmine Licopene Lutein Patente blue V Ponceau 4R Quinoline yellow Red 2G Riboflavin Sunset yellow FCF Tartrazine Total carotenoid Total Xantophyll

Flavors Vanillin

Preservatives and Acidifiers Acetic acid Benzoic acid Boric acid Calcium benzoate Calcium propionate Calcium sorbate Citric acid Formic acid Lactic acid Malic acid Natamycin Nitrate, Nitrite Parabens Potassium benzoate Potassium metabisulfite Potassium nitrate Potassium nitrite Potassium propionate Potassium sorbate Propionic acid Sodium benzoate Sodium bisulfite Sodium metabisulfite Sodium nitrate Sodium nitrite Sodium propionate Sodium sulfite Sorbic acid Sulfur dioxide Tartaric acid Total sulfur dioxide

Sweetners

Acesulfame K Aspartamine Cyclamate Isomalt Lactitol Maltitol Manitol Neohesperidin DC Saccharin Sorbitol Sucralase Sugar alcohol Xylitol

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Bioactives & Plant Extract Analyses 1,2-Octanediol 5-hydroxytryptophen A Aflatoxin Alcohol - assay Alcohol - Volatile Impurities Aloe: For isobarbaloin and barbaloin by HPLC Alpha Lipoic Acid Aminophylline Anyhydrous assay Andrographolide Anisidine Value in Oil Aristolochic acids Artichoke: Caffeylquinic acids Ascorbic Acid - assay in powders (USP) Ascorbic Acid - ID A Ascorbic Acid – ID B Ascorbic Acid assay (USP) in tablets Ash Ash - acid insoluble Ash - Acid insoluble and sulfated (USP) Ash - sulfated (BP) Ash by USP Aspartame - assay Aspirin - assay Atropine Sulfate Aucubin assay B Baicalin Banaba extract:corosolic acid Bee propolis: pinocembrin Bee Propolis - ID Beta Carotene Beta carotene assay Betaine Bilberry: Anthocyanosides & anthocyanidin Bilberry: bilberry* Biotin Bisacodyl assay Bismuth Subsalicylate - Assay for Salicylic acid Black Currant: gamma-linolenic acid (GLA), linoleic acid (LA) & other fatty acids Black Pepper: piperine

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Boswellia - ID Boswellia serrata: boswellic acids - (titration) Boswellia serrata: boswellic acids - (HPLC) Brix / Refractive Index Broccoli Sulforaphane Bromelain C Caffeine: Caffeine Camphor Carvacrol** Cayenne: Capsaicin Chasteberry - Vitexin Chlorophyllin Choline Bitartrate Chondroitin Sulfate Chondroitin: Chondroitin electrophoresis Cineol Cinnamon Bark:Cinnamon Citric acid - assay Citrus: aurantium synephrine Citrus: bioflavonoids - HPLC Citrus: hesperidin CLA Cocoa:theobromine Coenzyme 10 Cordyceps - assay: mannitol Cranberry:anthocyanosides Cranberry:organic acids (quinic, malic, citric and shikimic acids) Cranberry:proanthocyanidins Creatine Curcurma Cysteine D Devils Claw: Harpagoside Dioscorea villosa (Wild yam)– assay Diosmin D-mannose Dong Quai: Ligustilide Dong Quai (Chinese Angelica): Ferulic acid E Echinacea - ID A Echinacea - ID C Echinacea: total phenolics Ellagic Acid Ethylene Oxide

F Fatty Acid profile - (USP 30) Fatty Acid Profile - (AOAC, AOCS) Fish Oil: EPA and DHA Fish Oil: Total Omega-3 Flax Oil: linoleic acid (LA), alpha-linolenic acid (ALA), oleic acid and Gamma linolenic acid (GLA) Folic Acid Folic acid dissolution Fructooligosaccharides G Gallic acid Gamma linolenic acid (GLA) Garcinia cambogia: hydroxycitric acid Garlic: Allicin yield in acid Garlic: Alliinase Garlic: allicin Garlic: allicin & thiosulfinates Garlic: alliin Garlic: diallyl disulfide, diallyl trisulfide and methyl allyl trisulfide Garlic: (E,Z) - ajoene, vinyl dithiins, diallyl disulfide, diallyl trisulfide and methyl allyl trisulfide Garlic: S-methyl gammaglutamylcysteine, S-allyl gamma-glutamylcysteine and S-trans-1-propenyl gamma-glutamylcysteine Ginger: gingerols, shogaols and total pungent compounds Ginger: total gingerols Ginkgo: flavone glycosides Ginkgo: Rutin Ginkgo: terpene lactones Ginseng Siberian: eleutherosides B and E Ginseng American: total ginsenosides Ginseng Korean: total ginsenosides Glucosamine Glutamic Acid Glutamine Glycerine Glycerol

Glyceryl behenate Glycine Assay Goldenseal: hydrastine and berberine Grape Seed or Skin: proanthocyanidins Grape Seed or Skin: resveratrol Grape Seed or Skin: total polyphenols Green Tea: 6 total catechins Griffonia simplicifolia - assay Guaifenesin assay H Hawthorn assay Heavy Metals - ACS method Heavy metals - FCC method Heavy Metals - USP method I Heavy Metals - USP Method II Hesperidin Hydroxycitric Acid I ID by IR Identification Inositol Inositol Hexanicotinate Inulin assay Iodine Content (USP) Iodine in drug products Iodine Value Isoflavons K Kudzu: Total isoflavones L L-arginine L-Cystine assay (HPLC method) Licorice – assay Limit of non volatile residues Lipoic Acid Loss on Drying - ACS Loss on Drying (USP) Loss on Ignition l-Taurine - ID Lutein Lycopene

Bioactives & Plant Extract Analyses M Magnolia: honokiol and / or magnolol Malic Acid Mannitol Melatonin Menthol Metal analysis by ICP/MS Milk Thistle - ID B Milk Thistle (UV) Milk Thistle: HPLC Moisture Moisture by Karl Fischer MSM N N-Acetyl L-Cysteine N-acetyl-glucosamine Niacin Niacinamide O Olive leaf - assay Organic acids P Pantothenic Acid Peppermint oil assay Pesticide package Phytosterol profile (oil based products) Phytosterol profile (powders) Phytosterols Phytosterols - total Polyphenols Polysaccharides Pomegranate: ellagic acid Potassium benzoate Potassium sorbate Proanthyocanidins Psyllium Husk - Swell volume Psyllium husk- ID Pycnogenol Pygeum: beta-sitosterol Pygeum: total fatty acids Pygeum: total sterols Pyridoxide

Q Quercetin R Red Clover – assay Residue on Evaporation Residue on Ignition Resveratrol Riboflavin Ribose (sugar) Rosemary:carnosol and carnosic acid Rosemary oil: 1,8-cineole, camphor and safrole Rosemary: Rosmarinic acid Royal Jelly S Salicylic Acid Saw Palmetto: Free fatty acids Saw Palmetto: Total and free fatty acids Saw Palmetto: Total fatty acids Saw Palmetto: Total sterols Saw Pametto raw - ID Siberian ginseng - ID Soy: total isoflavones Specific Gravity (USP) St Johns Wort: hypericins Sterols Stevia - assay by HPLC Sucralose Sucrose & Glucose Sugars Sulforaphane Synephrine

(continued)

T Taurine (pure) Tea Tree Oil: terpinen-4-ol and 1,8-cineole content Theobromine Thiamin Total Bioflavonoid (Citrus) Turmeric - ID Turmeric: curcuminoids Tyrosine V Valerian: Valerenic acids Valine Vanilla Vinpocetine Vitamin A Vitamin A palmitate Vitamin B1 - assay Vitamin B12 Vitamin B2 Vitamin B3 Vitamin B5 Vitamin B6 Vitamin C Vitamin D Vitamin E Vitamin H1 Volatile Oil Content - (USP) Volatile Oil Content - (AOAC)

W Water Determination, Method 1, Karl Fischer Weight variation - fill weight Weight variation - USP Wild yam Diosgenin X Xanthan gum Z Zeaxanthin

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Contaminant Analyses Allergens (Detection) Almond–Qualitative Celery–Qualitative Egg–Quantitative (Ovalbumine) Fish–Qualitative Gluten–Quantitative (Gliadin) Hazelnut–Qualitative Milk ( ßlacto )–Quantitative de ß.lactoglobuline Milk ( caseine )–Quantitative (caséine) Milk ( lactose )–Detection and Dosage Mustard–Qualitative Nut package–Qualitative: Almond, hazelnut, pistachio, walnut, pecan nut, cashew, macadamia nut, Brazil nut Peanut–Qualitative Pistachio–Qualitative Sesame–Quantitative Sesame–Qualitative Shellfish Mollusk–Quantitative Soybean–Qualitative Sulfites–Detection Limit 3 mg/kg Lupin–Quantitative Walnut–Qualitative Wheat–Qualitative

Heavy Metals Antimony Arsenic Cadmium Chromium Lead Mercury Selenium

Mycotoxins

Aflatoxin B1 Aflatoxin M1 Aflatoxin M2 Aflatoxins B1-B2-G1-G2 Citrinin Deoxynivalenol Ergosterol Fumonisin B1 Ochratoxin A Patulin T2 toxin Trichotecenes Zearalenone

Pesticides Insecticides Aldrin Amitraz Carbamates Disulfoton Fluvalinate Malathion

Metidathion Organochlorine compound Organophosphate Pentachlorophenol Phosphide Pyrethroid Tetradifon Triazophos Herbicides Dicamba Glyphosate Isoxaben Mecoprop Pentachlorophenol Triazines and metabolites Trifluralin Fungicides Benomyl Captan Carbendazim Dinocap Fluazinam Folpet Imazalil Iprodione Myclobutanil Propamocarb Quintozene Tecnazene Thiabendazole Total dithiocarbamate

Other Contaminants Rotencide - Coumafene (warfarine) - Coumarine Polycyclic Aromatic Hydrocarbons - Benzo-apyrene Acrylamide Rotencide - Coumafene (warfarine) - Coumarine Dioxins - Polychlorobiphenyl type dioxins Radioactivity - Radioactivity (Radionucleids research)

Microbiology Analyses Qualitative Pathogens

Quantitative Pathogens

Given the proper environmental conditions, hazardous pathogens can grow, proliferate, and take harborage in your processing plant. With an exceptional knowledge of food matrices and regulatory requirements, Silliker microbiologists employ approved analytical methods to isolate and identify foodborne pathogens.

Spoilage organisms are a leading and annual cause of product waste and lost revenues in the global food industry. Protecting your product, bottom line, and valued customers against costly spoilage organisms requires accurate analytical data from a reputable resource. Our services include, but are not limited to:

Bacillus cereus Campylobacter Clostridium botulinum Clostridium perfringens Hemorraghic Escherichia coli Enteropathogenic E. coli E. sakazaki Listeria monocytogenes Salmonella Shigella Staphylococcus aureus Vibrio species Yersinia enterocolitica

Aerobic / Anaerobic plate counts Coliforms Escherichia coli Enterococci Yeast and mold counts Acidophiles Anaerobes Psychrotrophs Spore counts Thermophiles

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Stability Studies (Shelf-life and Challenge Studies) Shelf-life studies are essential tools to anticipate the behavior of products throughout their life. In addition to the shelf-life of products, they also allow companies to detect and correct formulation problems before they are sold to consumers. Silliker uses ICH standards (International Conference on Harmonization) for stability studies. ICH Standards are technical requirements within the pharmaceutical industry for development, manufacture, and pharmaceutical product analysis.

What is a stability study? Study during which a product is kept in the laboratory under set experimental conditions of temperature and humidity to detect any change in behavior or its components.

What are the advantages of stability studies?

uuTo establish the best-by, sell-by, or expiration date. uuReport of the minimum temperature during storage, transport and handling which must be respected. uuTo reduce costs due to the quality deterioration of a product on the market. uuTo identify product weaknesses and introduce the necessary changes in order to prolong shelf-life.

Objectives: The stability study can control the qualitative and quantitative evolution of the packaging, active ingredients and product microbial stability (raw materials, finished products). It aims to validate or determine the shelf-life before product selling.

History: The samples are stored in an environmental chamber where temperature and humidity are defined and controlled.

Study duration:

Example of planning under the specified guidance on the ICHQ1A standard:

Study

Storage conditions

Recommended Testing Frequency



Long-term Medium Accelerated

25°C ± 2°C / 60% RH ± 5% 30°C ± 2°C / 65% RH ± 5% 40°C ± 2°C / 75% RH ± 5%

0, 3, 6, 9, 12, 18, 24 and 36 months 0, 3, 6, 9 and 12 months 0, 3 and 6 months

Depending on the individual product stability, tests are conducted at frequencies defined in advance. In addition, light condition studies following the ICHQ1B (photostability testing) can also be performed.

Studies to determine shelf-life: uuChallenge Study: Study of the critical evolution of micro-organisms inoculated in the product at the worst possible doses. uuStudy of Critical Attributes Not Uniformly Distributed: evidence of the defect study on several representative batches of the product, having been stored under optimum conditions for the defect emergence. uuValidation Shelf-life Studies: They are based on the product evaluation at the end of its shelf life monitoring the stored samples regularly. uuSecondary Shelf-life Studies: Information on the period during which the product quality attributes remain unchanged, once the consumer has opened the package in accordance with the instructions on it.

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Biofortis - Providen Nutritional Clinical Studies Regulators are tightening their scrutiny and enforcement efforts in order to ensure health claims are reliable. Consumers are also becoming more demanding. As a result, food and pharmaceutical companies involved in nutrition need additional expertise and support to accelerate the development and commercialization of new products focused on health and wellness. Biofortis is a the leading global contract research organization performing clinical human nutrition studies. We provide clients with the ability to obtain scientific proof of claims for food, ingredients, nutritional supplements, drugs and medical nutrition products. Design the right protocol in order to achieve the desired results. This critical first step in completing an effective human nutrition study is a key competency of our experienced team. Exploration of the details for the study including the scientific approach, sample size calculation, placebo or control product definition, and development of a biostatistical plan will be part of the consultation. Biofortis has a unique expertise to design protocols for nutrition.

we ensure the highest standards in our work. We have been authorized by the health authorities in Europe for biomedical research in the field of nutrition on healthy human volunteers. To assure the accuracy of our assays, our central laboratory participates in proficiency testing programs and is registered on the list of clinical laboratories certified by the Cholesterol Reference Method Laboratory Network. Biofortis performs e-CRF11 and validated web solutions.

Conduct clinical trials under the highest quality standards. Closely connected to the expertise of in Europe, our team performs clinical trials in our own dedicated clinical investigation centers. Larger studies which span beyond a mono-centric approach are managed through qualified investigators including international locations. A large panel of healthy volunteers means that studies are completed quickly.

Study types

Assays to monitor the targeted biological system are central to outcome of any study. Through a central lab which specializes in metabolism disorders, we possess the capability to integrate the most recent biomarkers. Fully integrated processes provide a guarantee for quality control. Contract Research of new biochemical and genetic bacteria markers and exploration of intestinal metabolism also represent an important part of our Research & Development activities. In partnership with universities, Biofortis continues to explore in vitro assay development. Our DHPLC explores all mechanism of gut microflora.

A Quality Approach Biofortis is certified to the ICH E9 and ISO 9001:2008 standard, applying this quality-centric approach to the design, set-up and management of clinical studies. Applying Good Clinical Practices including detailed Standard Operating Procedures is another way

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uuWeight management satiety uuGastroenterology, gut microbiota uuMetabolism, cardiovascular health uuCognition, aging uuGlycemic and insulinemic index uuImmune defense

Central Lab uuBone – the measurement of hormones related to the mineralization through radiography (DEXA method) uuOxidative stress uuInflammation markers [not inflammatory] uuSatiety hormones and mediators uuLipids and lipoproteins uuMarkers of metabolic disorders uuBioavailability of vitamins and minerals uuIntestinal flora analysis

Services Performed Outside North America Genetically Modified Organisms (GMO)

(performed in Nantes,FR)

Products of Concern uuRaw products (seeds, cereals, …) uuPrimary processing products (starch, lecithin, cobbler, gluten, semolina, flour…) uuComplex finished products (ready-made dish, pudding, meal replacement, animal feeding…)

Analyses uuEndogenous target:corn, soybean, canola seed, wheat, tomato, rice uuScreening test: P35s, Tnos, Pnos, BAR, PAT, RR uuIdentification test : soja RRS, maïs Bt11, Bt176, Mon810, T25, GA21, Starlink, Herculex, NK603, Mon863, DAS 55122, riz LL601 and 62, canola seed... uuRegulatory analyses: package analysis evolving with European legislation uuVirus specific test: CAMV

Mixed Bacterial Species by dHPLC

(performed in Nantes,FR)

The Denaturing High Performance Liquid Chromatography (dHPLC) is a tool for the analysis of mixed bacterial species in various environments. This high speed and automated technology can analyze DNA fragments derived from human, animal, plant and microbial origins. Due to its speed and high resolution, this method is particularly useful for detecting polymorphisms in DNA. The dHPLC method can follow the evolution of microbial communities without a culture step. Diversity of Complex Flora Analyzed by dHPLC uuFood pathogen flora uuClinic disease flora uuIntestinal flora uuMouth flora uuSkin flora uuTechnology flora (ferments, probiotics) uuBeverages flora (bottled water, beer) Applications The dHPLC offers a wide range of applications regarding quality control, authenticity control and clinical studies: uuReal time evolution follow-up of specific flora (ex: impact of probiotic on target bacteria from intestinal flora) uuIdentification of bacterial species cultivable and noncultivable uuBacterial species differentiation in complex flora uuBacterial composition purity checking of manufacturing batches uuShelf life studies uuClinical studies uuTechnological flora studies uuFerments characterization uuAnalysis of antibiotics impact on flora

Target Products uuRaw food uuManufactured goods or finished products uuFermented food products (cheese, fresh dairy products)

wwBottled water wwInfant food (milk powders) wwBeer wwRobiotics wwSupplements uuSurface sample uuRinse water uuClinical sampling Advantages uuRapid and automated approach for identification of bacteria and fungi uuMonitor changes of microbial communities over time uuEasy handling uuSimplicity uuReproducible results uuSensitivity and accuracy

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Silliker, Inc. 111 E. Wacker Drive, Ste. 2300 Chicago, IL 60601 / USA Tel. +1 312 938 5151 email. [email protected] www.silliker.com 12