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Dietary Supplement Analytical Methods and Reference Materials Program (AMRM)

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Reference Materials for Dietary Supplement Analysis

NIST Standard Reference Material vials for omega-3 fatty acidsReference materials (RMs) are important resources for optimizing and verifying analytical measurements. An RM is a material that is homogenous and stable with respect to one or more specified properties. For food and dietary supplement RMs, the specified properties are often quantified values with uncertainties for select macro- and micronutrients, marker compounds, toxins, contaminants, and/or adulterants (1). Matrix-based and calibration RMs are therefore powerful tools for developing new analytical methods, verifying measurements of unknown samples, supporting quality assurance, and performing instrument calibrations.   

The AMRM Program makes available certified reference materials (CRMs), primarily through collaborative work with the National Institute of Standards and Technology (NIST)external link disclaimer, in which the target constituents are generally quantified by multiple analytical methods. In developing CRMs for botanical dietary supplements, NIST often engages with private sector suppliers and manufacturers to procure kilogram quantities of authenticated natural-matrix materials (e.g., vouchered whole plants or powdered plant parts). To the extent possible, NIST dietary supplement CRMs are designed as suites of materials representing the different manufacturing stages, such as a plant part (e.g., leaves or roots), an extract, and an oral dosage formulation.  To date, the AMRM Program has worked with NIST to develop more than 30 dietary supplement CRMsexternal link disclaimer.

NIH and NIST identify and prioritize needs for RMs by assessing biomedical research, methodological gaps, safety concerns, and market reports. AMRM-produced CRMs for dietary ingredients and supplements are not intended to represent an ideal or “gold standard” preparation. Although the CRMs must be derived from authenticated sources, their composition is not intended to set an industry standard, meet a given company’s specifications, or elicit a specific biological response. Rather, AMRM-produced CRMs are designed to represent the types of challenges that analysts might encounter with real-world samples when verifying ingredients or formulations or measuring clinical samples.

Through expanded use of RMs, dietary supplement stakeholders in academia, government, and industry can better advance biomedical research, protect public safety, ensure quality control, and promote public health (2).

1. SA Wise and MM Phillips. 2019. Anal Bioanal Chem 411(1):97-127external link disclaimer.
2. CA Rimmer, KE Sharpless, SA Wise, JM Betz, PM Coates. 2013. Anal Bioanal Chem 405(13):4337-44external link disclaimer.

The NIST Web site provides additional information about the dietary supplement reference materials program:

AMRM Supported NIST matrix Standard Reference Materials (SRM)external link disclaimer relevant for dietary supplements
NIST dietary supplement RMs have quantified values with uncertainties for select macro- and micronutrients, marker compounds, toxins, contaminants, and/or adulterants. These matrix-based RMs are powerful tools for developing new analytical methods, verifying measurements of unknown samples, supporting quality assurance, and performing instrument calibrations.

SRM

Description

Analytes with Certified or Reference Values

3232external link disclaimer

Kelp Powder (Thallus laminariae)

vitamins, elements

3235external link disclaimer

Soy Milk

vitamins, fatty acids, elements, amino acids

3236external link disclaimer

Soy Protein Isolate

flavonoid aglycones, isoflavones

3237external link disclaimer

Soy Protein Concentrate

isoflavones

3238external link disclaimer

Soy-Containing Solid Oral Dosage Form

flavonoid aglycones, isoflavones

3246external link disclaimer

Ginkgo biloba (Leaves)

flavonoid aglycones, terpene lactones (Ginkgolides), elements, DNA sequence

3247external link disclaimer

Ginkgo biloba (Extract)

flavonoid aglycones, terpene lactones (Ginkgolides), elements

3248external link disclaimer

Ginkgo-Containing Tablets

flavonoid aglycones, terpene lactones (Ginkgolides), elements

3250external link disclaimer

Saw Palmetto (Serenoa repens) Fruit

fatty acids

3251external link disclaimer

Saw Palmetto (Serenoa repens) Extract

fatty acids, carotenoids

3252external link disclaimer

Protein Drink Mix†

vitamins, fatty acids, elements, cholesterol, amino acids, protein, dietary fiber, carbohydrates

3253external link disclaimer

Yerba Mate Leaves

polycyclic aromatic hydrocarbons (PAHs), proximates

3254external link disclaimer

Green Tea (Camellia sinensis) Leaves

caffeine, catechins, theobromine, elements, amino acids

3255external link disclaimer

Green Tea (Camellia sinensis) Extract

caffeine, catechins, theobromine, elements, amino acids

3256external link disclaimer

Green Tea-Containing Solid Oral Dosage Form

caffeine, catechins, theobromine, elements, amino acids

3262external link disclaimer

St. John's Wort (Hypericum perforatum L.) Aerial Parts

flavonoid aglycones, elements, DNA sequence

3274external link disclaimer

Botanical Oils Containing Omega-3 and -6 Fatty Acids

fatty acids

3275external link disclaimer

Omega-3 and Omega-6 Fatty Acids in Fish Oil

fatty acids

3278external link disclaimer

Tocopherols in Edible Oils†

tocopherols

3280external link disclaimer

Multivitamin/Multielement Tablets

vitamins, elements, carotenoids

3281external link disclaimer

Cranberry (Fruit)

organic acids, sugars, elements, carbohydrates, antioxidant capacity

3282external link disclaimer

Low-Calorie Cranberry Juice Cocktail

organic acids, sugars, elements, phosphate, sulfate

3283external link disclaimer

Cranberry Extract

organic acids, antioxidant capacity

3284external link disclaimer

Cranberry-Containing Solid Oral Dosage Form

organic acids, antioxidant capacity

3285external link disclaimer

Mixed-Berry Containing Solid Oral Dosage Form

organic acids, antioxidant capacity

3291external link disclaimer

Bilberry Extract

organic acids, anions

3299external link disclaimer

Ground Turmeric (Curcuma longa L.) Rhizome

curcuminoids

3530external link disclaimer

Iodized Table Salt (Iodide)

elements

3532external link disclaimer

Calcium-Containing Solid Oral Dosage Form

vitamins, elements

Development not supported by NIH Office of Dietary Supplements