Accuracy of Labeling of Galantamine Generic Drugs and Dietary Supplements

Cohen, Pieter A.; Jacobs, Bram; Van Hoorde, Koenraad; Vanhee, Céline

doi:10.1001/jama.2024.0328

Cited by 2 publications

(2 citation statements)

References 8 publications

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“…The corresponding concentrations were calculated from the measured peak areas using the calibration curve. These calculated concentrations (i.e., the 5 concentration levels) were used to determine, for this concentration range and this compound, the applicability of a linear relationship between the measured and theoretical concentrations, the trueness, precision (repeatability and intermediated precision), and accuracy, by means of a validated Excel spreadsheet that was used previously [ 38 , 39 ]. The linearity of the generated method was deemed acceptable as the obtained R 2 values were above 0.999 and the p -values of the lack of fit (LOF) test were above 0.05.…”

Section: Methodsmentioning

confidence: 99%

“…Abbreviation: D3 = trideuterated compound, LLOQ = lower limit of quantification, ULOQ = upper limit of quantification, SIL = stable isotope labeled (C13). Validation of the quantification methodology: Validation of the monacolin quantitation method was performed based on ICH guidelines [35] and the total error approach [36,37], as was performed previously by our research group when analyzing food supplements [38,39]. Briefly, the selectivity and specificity of the method were assessed by comparing the 3 blank matrices and those same matrices spiked with the different compounds.…”

Section: Quantification Of Citrinin and Monacolin Kmentioning

confidence: 99%

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Quality Control and Safety Assessment of Online-Purchased Food Supplements Containing Red Yeast Rice (RYR)

Vanhee,

Jacobs,

Canfyn

et al. 2024

Foods

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Dietary supplements containing red yeast rice (RYR), a fermentation product of the fungus Monascus purpureus grown on white rice, remain popular in Europe as proclaimed cholesterol-lowering aids. The cholesterol-lowering effects are due to the occurrence of monacolin K, which is often present as a mixture of monacolin K lactone (MK) and as monacolin K hydroxy acid (MKA). MK is structurally similar to the cholesterol-lowering medicine lovastatin. Recently, due to safety concerns linked to the use of statins, the European Commission prohibited RYR supplements with a maximum serving exceeding 3 mg of total monacolins per day. Moreover, the amount of the mycotoxin citrinin, potentially produced by M. purpureus, was also reduced to 100 µg/kg. Evidently, manufacturers that offer their products on the European market, including the online market, must also be compliant with these limits in order to guarantee the safety of their products. Therefore, thirty-five different RYR supplements, purchased from an EU-bound e-commerce platform or from registered online pharmacies, were screened for their compliance to the European legislation for citrinin content and the amount of total monacolin K. This was conducted by means of a newly developed LC-MS/MS methodology that was validated according to ISO 17025. Moreover, these supplements were also screened for possible adulteration and any contamination by micro-organisms and/or mycotoxins. It was found that at least four of the thirty-five RYR supplements (≈11%) might have reason for concern for the safety of the consumer either due to high total monacolin K concentrations exceeding the European predefined limits for total monacolins or severe bacterial contamination. Moreover, three samples (≈9%) were likely adulterated, and the labeling of six of the seventeen samples (≈35%) originating from an EU-based e-commerce platform was not compliant, as either the mandatory warning was missing or incomplete or the total amount of monacolins was not mentioned.

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Section: Methodsmentioning

confidence: 99%