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Article ; Online: Use of qNMR to determine HPLC relative response factors for botanical reference standards used in pharmacopeial monographs.

Ma, Cuiying / Liu, Yang / Xu, Qun / Giancaspro, Gabriel I / Tan, Shane

Journal of pharmaceutical and biomedical analysis

2022 Volume 212, Page(s) 114618

Abstract: In modern botanical pharmacopeial monographs, one measurement of content is the quantitation of relevant constituents as marker compounds. The use of suitable reference standards (RSs) to quantify multiple compounds by HPLC is recommended in the U.S. ... ...

Abstract	In modern botanical pharmacopeial monographs, one measurement of content is the quantitation of relevant constituents as marker compounds. The use of suitable reference standards (RSs) to quantify multiple compounds by HPLC is recommended in the U.S. Pharmacopeial (USP) botanical monographs. However, these substances may be expensive and difficult to develop into an RS. Surrogate RSs could be used instead of the actual constituents, provided that the relative response factors (RRFs) of each analyte to the selected surrogate RS are known. USP monographs of both Sichuan Lovage Rhizome and Dong Quai Root recognize Z-ligustilide as a major characteristic marker compound, making quantitation of Z-ligustilide and its analog(s) relevant for quality control. However, because Z-ligustilide is unstable, it is difficult to develop it into a quantitative RS. Instead, oxybenzone was selected as a surrogate external quantitative RS because of its similar chromatographic behavior to Z-ligustilide, its stability, and affordable cost. The RRF determination of Z-ligustilide to oxybenzone by the conventional HPLC procedure is challenging due to both the instability of the purified Z-ligustilide at ambient temperature and the difficulty of determining its purity. Therefore, a qNMR method was used to overcome these challenges as it enables to directly measure the mass ratio of Z-ligustilide to oxybenzone in the stock solution without the need for weighing and purity information. In the present study, RRF values of 1.01, 0.46, and 0.89 for Z-ligustilide, senkyunolide A, and ferulic acid relative to oxybenzone, respectively, were determined using the qNMR-based methodology.
MeSH term(s)	Chromatography, High Pressure Liquid/methods ; Ligusticum/chemistry ; Quality Control ; Reference Standards ; Rhizome
Language	English
Publishing date	2022-01-26
Publishing country	England
Document type	Journal Article
ZDB-ID	604917-5
ISSN	1873-264X ; 0731-7085
ISSN (online)	1873-264X
ISSN	0731-7085
DOI	10.1016/j.jpba.2022.114618
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Article: An Effective Workflow for Differentiating the Same Genus Herbs of Chrysanthemum morifolium Flower and Chrysanthemum Indicum Flower.

He, Jiao / Zhang, Qian / Ma, Cuiying / Giancaspro, Gabriel I / Bi, Kaishun / Li, Qing

Frontiers in pharmacology

2021 Volume 12, Page(s) 575726

Abstract: ... ...

Abstract	C
Language	English
Publishing date	2021-04-22
Publishing country	Switzerland
Document type	Journal Article
ZDB-ID	2587355-6
ISSN	1663-9812
ISSN	1663-9812
DOI	10.3389/fphar.2021.575726
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Article ; Online: What Should Clinicians Know About Dietary Supplement Quality?

Brykman, Marissa Chaet / Streusand Goldman, Virginia / Sarma, Nandakumara / Oketch-Rabah, Hellen A / Biswas, Deborah / Giancaspro, Gabriel I

AMA journal of ethics

2022 Volume 24, Issue 5, Page(s) E382–389

Abstract: Increase in dietary supplement use in the United States suggests a great need for clinicians to be aware of the range of supplements' quality parameters. Regulatory requirements exist, but specific quality parameters for each ingredient are not set by ... ...

Abstract	Increase in dietary supplement use in the United States suggests a great need for clinicians to be aware of the range of supplements' quality parameters. Regulatory requirements exist, but specific quality parameters for each ingredient are not set by regulators. This article considers how clinicians can evaluate dietary supplement product quality, assess manufacturers' adherence to public quality standards, and encourage use of verification and certification programs.
MeSH term(s)	Dietary Supplements ; Humans ; Reference Standards ; United States ; United States Food and Drug Administration
Language	English
Publishing date	2022-05-01
Publishing country	United States
Document type	Journal Article
ISSN	2376-6980
ISSN (online)	2376-6980
DOI	10.1001/amajethics.2022.382
Database	MEDical Literature Analysis and Retrieval System OnLINE

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Article ; Online: Pharmaceutical analysis by NMR can accommodate strict impurity thresholds: The case of choline.

Achanta, Prabhakar S / Niemitz, Matthias / Friesen, J Brent / Tadjimukhamedov, Fatkhulla K / Bzhelyansky, Anton / Giancaspro, Gabriel I / Chen, Shao-Nong / Pauli, Guido F

Journal of pharmaceutical and biomedical analysis

2022 Volume 214, Page(s) 114709

Abstract: The ICH guidelines recommend reporting thresholds for regular impurities in drug substances at the level of 0.05% or 0.03% (w/w) depending on the maximum daily intake. Therefore, any instrumental method of analysis applicable to the impurity analysis ... ...

Abstract	The ICH guidelines recommend reporting thresholds for regular impurities in drug substances at the level of 0.05% or 0.03% (w/w) depending on the maximum daily intake. Therefore, any instrumental method of analysis applicable to the impurity analysis should be able to detect and quantify the analytes at those levels. This investigation was designed to verify the suitability of
MeSH term(s)	Choline ; Chromatography, High Pressure Liquid/methods ; Drug Contamination ; Magnetic Resonance Imaging/methods ; Magnetic Resonance Spectroscopy/methods ; Pharmaceutical Preparations
Chemical Substances	Pharmaceutical Preparations ; Choline (N91BDP6H0X)
Language	English
Publishing date	2022-03-05
Publishing country	England
Document type	Journal Article
ZDB-ID	604917-5
ISSN	1873-264X ; 0731-7085
ISSN (online)	1873-264X
ISSN	0731-7085
DOI	10.1016/j.jpba.2022.114709
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Article ; Online: NMR-Based Quantum Mechanical Analysis Builds Trust and Orthogonality in Structural Analysis: The Case of a Bisdesmosidic Triglycoside as

Bhavaraju, Sitaram / Taylor, David / Niemitz, Matthias / Lankin, David C / Bzhelyansky, Anton / Giancaspro, Gabriel I / Liu, Yang / Pauli, Guido F

Journal of natural products

2021 Volume 84, Issue 3, Page(s) 836–845

Abstract: The present study demonstrates the relationship between conventional and quantum mechanical (QM) NMR spectroscopic analyses, shown here to assist in building a convincingly orthogonal platform for the solution and documentation of demanding structures. ... ...

Abstract	The present study demonstrates the relationship between conventional and quantum mechanical (QM) NMR spectroscopic analyses, shown here to assist in building a convincingly orthogonal platform for the solution and documentation of demanding structures. Kaempferol-3-
MeSH term(s)	Flavonols/analysis ; Glycosides/analysis ; Kaempferols/analysis ; Magnetic Resonance Spectroscopy/standards ; Monosaccharides/analysis ; Plant Components, Aerial/chemistry ; Withania/chemistry
Chemical Substances	Flavonols ; Glycosides ; Kaempferols ; Monosaccharides ; kaempferol-3-O-glucoside
Language	English
Publishing date	2021-02-24
Publishing country	United States
Document type	Journal Article ; Research Support, N.I.H., Extramural ; Research Support, Non-U.S. Gov't
ZDB-ID	304325-3
ISSN	1520-6025 ; 0163-3864
ISSN (online)	1520-6025
ISSN	0163-3864
DOI	10.1021/acs.jnatprod.0c01131
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Article: NMR-Based Quantum Mechanical Analysis Builds Trust and Orthogonality in Structural Analysis: The Case of a Bisdesmosidic Triglycoside as Withania somnifera Aerial Parts Marker

Bhavaraju, Sitaram / Taylor, David / Niemitz, Matthias / Lankin, David C / Bzhelyansky, Anton / Giancaspro, Gabriel I / Liu, Yang / Pauli, Guido F

Journal of natural products. 2021 Feb. 24, v. 84, no. 3

2021

Abstract	The present study demonstrates the relationship between conventional and quantum mechanical (QM) NMR spectroscopic analyses, shown here to assist in building a convincingly orthogonal platform for the solution and documentation of demanding structures. Kaempferol-3-O-robinoside-7-O-glucoside, a bisdesmosidic flavonol triglycoside and botanical marker for the aerial parts of Withania somnifera, served as an exemplary case. As demonstrated, QM-based ¹H iterative full spin analysis (HiFSA) advances the understanding of both individual nuclear resonance spin patterns and the entire ¹H NMR spectrum of a molecule and establishes structurally determinant, numerical HiFSA profiles. The combination of HiFSA with regular 1D ¹H NMR spectra allows for simplified yet specific identification tests via comparison of high-quality experimental with QM-calculated spectra. HiFSA accounts for all features encountered in ¹H NMR spectra: nonlinear high-order effects, complex multiplets, and their usually overlapped signals. As HiFSA replicates spectrum patterns from field-independent parameters with high accuracy, this methodology can be ported to low-field NMR instruments (40–100 MHz). With its reliance on experimental NMR evidence, the QM approach builds up confidence in structural characterization and potentially reduces identity analyses to simple 1D ¹H NMR experiments. This approach may lead to efficient implementation of conclusive identification tests in pharmacopeial and regulatory analyses: from simple organics to complex natural products.
Keywords	Withania somnifera ; flavonols ; quantum mechanics
Language	English
Dates of publication	2021-0224
Size	p. 836-845.
Publishing place	American Chemical Society and American Society of Pharmacognosy
Document type	Article
Note	NAL-AP-2-clean
ZDB-ID	304325-3
ISSN	1520-6025 ; 0163-3864
ISSN (online)	1520-6025
ISSN	0163-3864
DOI	10.1021/acs.jnatprod.0c01131
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Article ; Online: Challenges and Opportunities for Improving the Safety Assessment of Botanical Dietary Supplements: A United States Pharmacopeia Perspective.

Oketch-Rabah, Hellen A / Roe, Amy L / Muldoon-Jacobs, Kristi / Giancaspro, Gabriel I

Clinical pharmacology and therapeutics

2018 Volume 104, Issue 3, Page(s) 426–429

Abstract: The United States Pharmacopeia (USP) is an independent, nonprofit, science-based organization whose mission is to improve global health through public quality standards for dietary supplements, medicines, and food ingredients. ...

Abstract	The United States Pharmacopeia (USP) is an independent, nonprofit, science-based organization whose mission is to improve global health through public quality standards for dietary supplements, medicines, and food ingredients.
MeSH term(s)	Animals ; Consumer Product Safety/standards ; Dietary Supplements/adverse effects ; Dietary Supplements/standards ; Humans ; Patient Safety/standards ; Pharmacopoeias as Topic/standards ; Phytotherapy/adverse effects ; Phytotherapy/standards ; Plant Preparations/adverse effects ; Plant Preparations/standards ; Quality Control ; Quality Improvement/standards ; Risk Assessment ; United States
Chemical Substances	Plant Preparations
Language	English
Publishing date	2018-07-31
Publishing country	United States
Document type	Journal Article
ZDB-ID	123793-7
ISSN	1532-6535 ; 0009-9236
ISSN (online)	1532-6535
ISSN	0009-9236
DOI	10.1002/cpt.1113
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Article ; Online: Letter to the Editor in response to "Adulteration of Ginkgo biloba products and a simple method to improve its detection" by Wohlmuth et al.

Bzhelyansky, Anton / Sarma, Nandakumara / Giancaspro, Gabriel I

Phytomedicine : international journal of phytotherapy and phytopharmacology

2014 Volume 21, Issue 12, Page(s) 1497

MeSH term(s)	Drug Contamination ; Flavonols/analysis ; Genistein/analysis ; Ginkgo biloba/chemistry ; Glycosides/analysis ; Plant Extracts/chemistry
Chemical Substances	Flavonols ; Glycosides ; Plant Extracts ; Genistein (DH2M523P0H)
Language	English
Publishing date	2014-10-15
Publishing country	Germany
Document type	Comment ; Letter
ZDB-ID	1205240-1
ISSN	1618-095X ; 0944-7113
ISSN (online)	1618-095X
ISSN	0944-7113
DOI	10.1016/j.phymed.2014.06.020
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Article ; Online: The Importance of Quality Specifications in Safety Assessments of Amino Acids: The Cases of l-Tryptophan and l-Citrulline.

Oketch-Rabah, Hellen A / Roe, Amy L / Gurley, Bill J / Griffiths, James C / Giancaspro, Gabriel I

The Journal of nutrition

2016 Volume 146, Issue 12, Page(s) 2643S–2651S

Abstract: The increasing consumption of amino acids from a wide variety of sources, including dietary supplements, natural health products, medical foods, infant formulas, athletic and work-out products, herbal medicines, and other national and international ... ...

Abstract	The increasing consumption of amino acids from a wide variety of sources, including dietary supplements, natural health products, medical foods, infant formulas, athletic and work-out products, herbal medicines, and other national and international categories of nutritional and functional food products, increases the exposure to amino acids to amounts far beyond those normally obtained from the diet, thereby necessitating appropriate and robust safety assessments of these ingredients. Safety assessments of amino acids, similar to all food constituents, largely rely on the establishment of an upper limit [Tolerable Upper Intake Level (UL)] considered to be a guide for avoiding high intake, above which adverse or toxic effects might occur. However, reliable ULs have been difficult or impossible to define for amino acids because of inadequate toxicity studies in animals and scarce or missing clinical data, as well as a paucity or absence of adverse event reporting data. This review examines 2 amino acids that have been associated with in-market adverse events to show how quality specifications might have helped prevent the adverse clinical outcomes. We further highlight the importance of various factors that should be incorporated into an overall safety assessment of these and other amino acids. In addition to the traditional reliance on the established UL, well-defined quality specifications, review of synthesis and production strategies, potential interactions with drugs, contraindications with certain disease states, and cautionary use within certain age groups should all be taken into consideration.
MeSH term(s)	Citrulline/adverse effects ; Dietary Supplements ; Humans ; Quality Control ; Toxicity Tests ; Tryptophan/adverse effects
Chemical Substances	Citrulline (29VT07BGDA) ; Tryptophan (8DUH1N11BX)
Language	English
Publishing date	2016-11-09
Publishing country	United States
Document type	Journal Article ; Review
ZDB-ID	218373-0
ISSN	1541-6100 ; 0022-3166
ISSN (online)	1541-6100
ISSN	0022-3166
DOI	10.3945/jn.115.227280
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Article: Multi-Criteria Decision Analysis Model for Assessing the Risk from Multi-Ingredient Dietary Supplements (MIDS)

Oketch-Rabah, Hellen A / Hardy, Mary L / Patton, Allison P / Chung, Mei / Sarma, Nandakumara D / Yoe, Charlie / Ayyadurai, V. A. Shiva / Fox, Mary A / Jordan, Scott A / Mwamburi, Mkaya / Mould, Diane R / Osterberg, Robert E / Hilmas, Corey / Tiwari, Ram / Valerio, Luis / Jones, Donnamaria / Deuster, Patricia A / Giancaspro, Gabriel I

Journal of dietary supplements. 2021 May 4, v. 18, no. 3

2021

Abstract: Military personnel use dietary supplements (DS) for performance enhancement, bodybuilding, weight loss, and to maintain health. Adverse events, including cardiovascular (CV) effects, have been reported in military personnel taking supplements. Previous ... ...

Abstract	Military personnel use dietary supplements (DS) for performance enhancement, bodybuilding, weight loss, and to maintain health. Adverse events, including cardiovascular (CV) effects, have been reported in military personnel taking supplements. Previous research determined that ingestion of multi-ingredient dietary supplements (MIDS), can lead to signals of safety concerns. Therefore, to assess the safety of MIDS, the Department of Defense via a contractor explored the development of a model-based risk assessment tool. We present a strategy and preliminary novel multi-criteria decision analysis (MCDA)-based tool for assessing the risk of adverse CV effects from MIDS. The tool integrates toxicology and other relevant data available on MIDS; likelihood of exposure, and biologic plausibility that could contribute to specific aspects of risk. Inputs for the model are values of four measures assigned based on the available evidence supplemented with the opinion of experts in toxicology, modeling, risk assessment etc. Measures were weighted based on the experts’ assessment of measures’ relative importance. Finally, all data for the four measures were integrated to provide a risk potential of 0 (low risk) to 100 (high risk) that defines the relative risk of a MIDS to cause adverse reactions. We conclude that the best available evidence must be supplemented with the opinion of experts in medicine, toxicology and pharmacology. Model-based approaches are useful to inform risk assessment in the absence of data. This MCDA model provides a foundation for refinement and validation of accuracy of the model predictions as new evidence becomes available.
Keywords	ingestion ; medicine ; military personnel ; models ; multi-criteria decision making ; pharmacology ; relative risk ; risk assessment ; strength training ; toxicology ; weight loss
Language	English
Dates of publication	2021-0504
Size	p. 293-315.
Publishing place	Taylor & Francis
Document type	Article
Note	NAL-AP-2-clean
ZDB-ID	2460305-3
ISSN	1939-022X ; 1939-0211
ISSN (online)	1939-022X
ISSN	1939-0211
DOI	10.1080/19390211.2020.1741485
Database	NAL-Catalogue (AGRICOLA)

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