AXIO | Proficiency Testing schemes 2025
AXIO Proficiency Testing sample PT-PH-21 is designed to assess the compliance with labelling
Sample
Quantity
Supplied as
Target Analyte(s)
PT-PH-21 Potency of multielement
15g
Multielement supplement
Calcium; Zinc; Magnesium; Copper; Manganese; Potassium; Iron; Total Chromium; Selenium; Compliance with labelling.
In this unique PT sample, AXIO provides a means for laboratories to assess the compliance of a dietary supplement product with the claims or information provided on the label. Based on the label provided in the instruction sheet, their obtained testing results (including the uncertainty of measurement) and the guidance documents, laboratories must decide whether they would consider the product compliant or not.
How does Proficiency test assess the compliance with labelling? The PT Test material comprises of 2 parts:
1 label
1 foil bag containing multi-element tablets (approximately 15g)
After testing the tablets, laboratories will determine the value for each analyte, including uncertainty of measurement. Laboratories will assess their values against the label value, using the Code of Federal Regulation Title 21 (21 CFR 101.9(g)(3)) and (g)(4)). *
Laboratory result
Label
Value (mg per g)
Uncertainty
Range
Label (mg per 1.3g)
Label (mg per g)
Compliance
Calcium
162.59
15.3
147.29
177.89
200
153.846
YES YES YES
Zinc
5.03
1.1
3.93
6.13
10
7.692
Magnesium
51.66
8.2
43.46
59.86
75
57.692
Potassium
2.25
0.3
1.95
2.55
1.3
1.000
NO
Copper
0.79
0.08
0.71
0.87
1
0.769
YES
Selenium
0.05
0.01
0.04
0.06
0.15
0.115
NO
*Non-US participants will possibly use other assessment rules, e.g. EU: Guidance document for competent authorities for the control of compliance with EU Regulation (EU) No 1169/2011 of the European Parliament and of the Council of 25 October 2011 on the provision of food information to consumers (2012)
lgcstandards.com/AXIO 37
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