Dietary Supplements with Proline—A Comprehensive Assessment of Their Quality
Abstract
:1. Introduction
2. Materials and Methods
2.1. Samples
2.2. Reagents
2.3. Sample Preparation
2.4. Qualitative Analysis
2.5. Quantitative Analysis
2.6. Dissolution Test for Tablets or Capsules
2.7. Expanded Uncertainty
- —mean [mg] Pro content determined in tablet/capsule (n = 3);
- —mean [mg] amount of Pro released;
- —standard uncertainties of the measured values: and determined according to the formula:
- —standard deviation of the amount of Pro in dosage unit [mg] or standard deviation of the released amount of Pro [mg];
- n—the number of tablets or capsules used for analysed.
3. Results and Discussion
3.1. Tentative Contaminants Present in Pro Supplements
3.2. Determination of Pro in Dietary Supplements
3.3. Dissolution Test for Pro Tablets and Capsules
4. Conclusions
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Conflicts of Interest
References
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Code | Formula | Neutral Mass Calculated from the Formula [Da] | Δ Mass [Da] | Δ Mass [ppm] | RDBE a | H/C b | SFit c [%] | PC d [%] | X/Pro e [%] | Fragments [m/z] | Dietary Supplements Containing Contaminant (% of the Analysed) | Tentative Name |
---|---|---|---|---|---|---|---|---|---|---|---|---|
A1 | C9 H12 O2 | 152.08373 | 0.00002 | 0.16 | 4 | 1.3 | 81.54 | 99.48 | 3.51–7.61 | 83.04901; 93.06975; 107.08539; 111.04391; 125.05946; 135.07991 | All (100%) | 4-ethylguaiacol |
A2 | C6 H7 N O3 S | 173.01466 | 0.00005 | 0.27 | 4 | 1.2 | 70.72 | 98.46 | 2.18 | 93.05725 | Pro7 (14%) | 4-methylpyridine-3-sulfonic acid |
A3 | C11 H13 N3 O3 S | 267.06776 | −0.00027 | −1.01 | 7 | 1.2 | 63.45 | 100.00 | 2.53 | 92.04922; 108.04426; 113.07071; 156.01105 | Pro7 (14%) | Sulfisoxazole |
A4 | C18 H37 N O | 283.28751 | −0.00002 | −0.07 | 1 | 2.1 | 91.29 | 99.90 | 5.65 | 88.07558; 102.09121; 116.10651 | Pro3 (14%) | Stearamide |
A5 | C22 H43 N O | 337.33446 | 0.00003 | 0.08 | 2 | 2.0 | 65.66 | 99.82 | 0.94–1.25 | 83.08537; 97.10140; 109.10137; 149.13242; 303.30444; 321.31512 | Pro3, Pro5 (28%) | Erucamide |
Code | Dosage Form | Source | Declared Pro Content [mg/unit] | Determined Pro Content [mg/unit] a | Maximum Difference [%] |
---|---|---|---|---|---|
Pro1 | Capsule | Poland | 520 | 546 (CV = 9.9%) | 15 |
Pro2 | Capsule | Poland | 500 | 375 (CV = 2.0%) | −27 |
Pro3 | Capsule | United States | 500 | 522 (CV = 5.9%) | 9 |
Pro4 | Capsule | Germany | 400 | 375 (CV = 9.8%) | −16 |
Pro5 | Capsule | United States | 500 | 587 (CV = 2.6%) | 21 |
Pro6 | Capsule | Poland | 270 | 263 (CV = 7.2%) | −11 |
Pro7 | Tablet | United States | 25 | 33 (CV = 16.4%) | 56 |
Code | The Average Percentage of Pro Amount Released from a Dosage Form (Standard Deviation n = 6) | Expanded Uncertainty Parameters | ||||||
---|---|---|---|---|---|---|---|---|
pH 1.2 | pH 6.8 | |||||||
pH 1.2 | pH 6.8 | Equal a | Equal a | |||||
Pro1 | 47 (42) | 85.0 (7.4) | 300.1 | 187.6 | No | 104.4 | 70.1 | No |
Pro2 | 82 (13) | 79 (16) | 33.2 | 52.3 | Yes | 19.1 | 61.9 | Yes |
Pro3 | 90.0 (5.2) | 74.9 (4.8) | 71.8 | 41.5 | No | 147.4 | 40.7 | No |
Pro4 | 11 (12) | 10 (10) | 328.9 | 57.6 | No | 334.6 | 52.9 | No |
Pro5 | 131 (30) | 118.6 (5.9) | 65.4 | 122.5 | Yes | 5.8 | 29.5 | Yes |
Pro6 | 91 (12) | 2.0 (1.1) | 17.8 | 32.9 | Yes | 257.9 | 21.9 | No |
Pro7 | 105 (19) | 77 (12) | 6.7 | 7.3 | Yes | 13.9 | 6.7 | No |
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Stępień, K.A.; Krawczyk, W.; Giebułtowicz, J. Dietary Supplements with Proline—A Comprehensive Assessment of Their Quality. Life 2023, 13, 263. https://doi.org/10.3390/life13020263
Stępień KA, Krawczyk W, Giebułtowicz J. Dietary Supplements with Proline—A Comprehensive Assessment of Their Quality. Life. 2023; 13(2):263. https://doi.org/10.3390/life13020263
Chicago/Turabian StyleStępień, Krzysztof Adam, Weronika Krawczyk, and Joanna Giebułtowicz. 2023. "Dietary Supplements with Proline—A Comprehensive Assessment of Their Quality" Life 13, no. 2: 263. https://doi.org/10.3390/life13020263