AOAC Stakeholder Panel on Dietary Supplements: Background and Fitness for Purpose for

Anton Bzhelyansky AOAC 2016 Annual Meeting – Dallas, TX, USA SPDS September 16, 2016

Ginger

The ginger plant is a herbaceous perennial grown as an annual crop. The plant is erect, has many fibrous roots, aerial shoots (pseudostem) with leaves, and the underground stem ().

Ginger ( officinale Roscoe) is a sterile, reed-like plant with a pungenttd and aromati tihic rhizome on w hihitlifhich it relies for vege ttitative propagation. The plant is a cultigen, that is, it is only known from cultivation. Its wild origins are not known with certainty but are believed to be India or South-East Asia.

Ginger rhizome, known as Rhizoma Zingiberis in pharmacy is used in several traditional systems of medicine, including Traditional Chinese Medicine, and Western . Its traditional uses cover a great variety of complaints including dyspepsia, flatulence and colic, nausea and vomiting, colds and flu, migraine, as well as muscular and rheumatic disorders.

Wohlmuth, H 2008, 'Phytochemistry and pharmacology of from the ginger family, ', PhD thesis, Southern Cross University, Lismore, NSW. Ginger Rhizome Production, Processing and Chemical Composition

Ginger Production*

Ginger is one of the earliest important species grown in the Western hemisphere reported to be a native of Southeast Asia. Gingqger requires a warm tem perature (29-35 degree Celsius) and a humid climate for growth. It also requires a distinctive pattern of rainfall of at least 150 to 200 cm during the growing period and no rainfall a month prior to harvest.

In 2013, world production of ginger was reported to be 2.14 ton; the major producers, India and China, accounting for hlffthhalf of the wor ld’s ou tpu t.

Indonesia, Nepal, Nigeria and Thailand account for additional 36%.

The United States’ production of ginger amounts to about 0.04%, or 774 tons.

*Data from FAOSTAT, retrieved Tue Sep 06 01:34:37 CEST 2016 Ginger Processing

Ginger is harvested when stalks exhibit yellowing and withering, about nine (9) months after planting. Maximum oil and content is typically reached between 150 and 170 days.

POST HARVEST HANDLING A. Washing – are washed, cleaned from debris, shoots and roots. B. “Killing” – 10-min. immersion in boiling water, to terminate enzymatic processes. C.Drying to 8-10% moisture. D.Dry storage at 10-15 ⁰C. E. Solvent extraction is conducted preferably on unpeeled ginger. Dried powdered rhizomes extracted by percolation, and the extract Is then distilled at 45-55 ⁰C. Typical extraction solvents: ethyl acetate, hexane, or

supercritical CO2.

FAO: Ginger: Post-Production Management for Improved Market Access

Two-Stage Extraction of Ginger

Two-Stage Extraction: Ginger is ground and first steam distilled to obtain the volatile oil. This oil represents the aroma of the spice. The de-oiled spice is then subjected to solvent extraction to recover the nonvolatile principles. The aroma and taste fractions are proportionately blended to give the oleoresin of the spice. Since the aroma and pungency fractions are isolated individually, their relative percentages in the end product can be adjusted at will.

Acetone, methanol, isopropanol, methylene chloride, ethyyyl acetate, and ethyl alcohol are popular extraction solvents for ginger. Ethylene dichloride is an efficient extractant; however, its use is restricted due to alleged carcinogenicity. Ginger Chemical Composition

Ginger Constituents (WHO)

Major constituents The rhizome contains 1–4% essential oil and an oleoresin.

The composition of the essential oil varies as a function of geographical origin, but the chief constituent sesquiterpene hydrocarbons (responsible for the aroma) seem to remain constant. These compounds include (-)-zingiberene, (+)-ar-curcumene, (-)-β- sesquiphellandrene, and β-bisabolene. Monoterpene aldehydes and alcohols are also present.

The constituents responsible for the pungent taste of the drug and possibly part of its anti-emetic properties have been identified as 1-(3- methoxy-4-hydroxyphenyl)-5-hydroxyalkan-3-ones, known as [3–6]-, [8]-, [10]-, and [12]- (having a side-chain with 7–10, 12, 14, or 16 carbon atoms, respectively) and their corresponding dehydration products, which are known as . Gingerols

O OH Gingerols are homologues of 1-(3- H3CO 2 4 1 3 5 methoxy-4-hydroxyphenyl)-3-keto-5- CH3 [6]- hhdydroxy hexane an d iildthbnclude the subgroup HO methylgingerols.

O OH Universally acknowledged as major H3CO CH3 constituents of ginger “pungent principles”.

(5S)-[8]-Gingerol Gingerols are thermally labile and undergo HO chemical changes during processing and O OH storage.

H3CO CH3 (5R)-[8]-Gingerol HO

O OH

H3CO CH3

[10]-Gingerol HO

Shogaols

O Shogaols are dehydration products of the H3CO CH3 gingerols. [6]- HO Sometimes considered the degradation

O products of gingerols, shogaols, in fact were found to readily interconvert into H3CO CH3 gingerols at specific conditions. [8]-Shogaol HO Shogaols are strong contributors to ginger O “pungent principles”. Thermal treatment of

H3CO ginger rhizome is commonly undertaken to CH3 enhance content of shogaols . [6]-Shogaol [10]-Shogaol HO is considered a more “pungent” constituent relative to [6]-gingerol, and in numerous bioactivity studies was shown to outperform the latter.

Content of shogaols increases significantly in ginger extracts.

O Paradols are β-ketone hydroxyl H3CO CH3 deoxygenation products of gggingerols. [6]- HO Paradols represent another subclass of O ginger ‘pungent principles’, and possess

H3CO marked bioactivity. CH3 [8]-Paradol HO The content of paradols is more pronounced in ginger extracts as opposed to the fresh O plant material.

H3CO CH3 [10]-Paradol HO

Gingerdiols and Gingerdiones

OH OH O O

H3CO H3CO CH3 CH3 (3R,5S)-[6]-Gingerdiol [6]-Gingerdione HO HO

OH OH O O

H3CO H3CO CH3 CH3 (3S,5S)-[6]-Gingerdiol [8]-Gingerdione HO HO

OH OH O O H CO H3CO 3 CH CH3 3 [10]-Gingerdione (3R,5S)-[10]-Gingerdiol HO HO

OH OH O O

H3CO H CO CH 3 3 (CH2)nCH3 (3S,5S)-[10]-Gingerdiol 1-Dehydro-gingerdiones HO HO

Gingerdiols are ketone reduction products Gingerdiones are β-ketone hydroxyl dehydrogenation products of gingerols; of gingerols. include the subgroup of 1-dehydroginger- diones. Major Ginger Sesquiterpenes

Sesquiterpenes are primarily contained in ggginger volatile oil, but also in the oleoresin.

The six major ginger sesquiterpenes are shown here.

Zerumbone is the constituent of recent intense interest, with a number of investigations regarding its bioactivity publis he d.

Zingerone (Vanillylacetone)

Zingerone is absent in fresh ginger but cooking or heating transforms gingerol to zingerone.

Zingerone has antiinflammatory, antidiabetic, antilipolytic, antidiarrhoeic, and antispasmodic properties. Besides, it enhances growth and stimulate immune system. It behaves as appetite stimulant, anxiolytic, antithrombotic, radiation protective, and antimicrobial. Pungent Principles as a Function of Ginger Cultivar

Ginger Pungent Principles as a Function of the Extraction Solvent Ginger in Pharmacopeial and Related Texts

The Pharmacopœia of the United States of America, 6th Edition, 1882 The United States Homeopathic Pharmacopœia, 1878

British Pharmacopoeia 16th Edition, 2016

Ginger (Ph. Eur. monograph 1522) Content: Minimum 15 mL/kg of essential oil (anhydrous drug). Identification: Macroscopic, microscopic, TLC Tests: Water (NMT 100 mL/kg), Total Ash (NMT 6.0%) Assay: Essential oil (NLT 15 mL/kg) Use 20.0 g of the freshly, coarsely powdered herbal drug, a 1000 mL round-bottomed flask, 10 drops of liquid paraffin R or other antifoam, 500 mL of water R as distillation liquid and 0.5 mL of xylene R in the graduated tube. Distil at a rate of 2-3 mL/min for 4 h.

Strong Ginger Tincture Tests: Ethanol content (80 – 88%), Dry residue (2.0 – 3.0%), Relative density (0.832 – 0.846)

Weak Ginger Tincture Tests: Ethanol content (86 – 90%), Dry residue (NLT 0.4%), Relative density (0.825 – 0.835) European Pharmacopoeia 9th Edition, 2017

Ginger (Zingiberis rhizoma) Content: Minimum 15 mL/kg of essential oil (anhydrous drug). Identification: Macroscopic, microscopic, TLC (against citral and resorcinol) Tests: Water (NMT 100 mL/kg), Total Ash (NMT 6.0%) Assay: Essential oil (NLT 15 mL/kg) Use 20.0 g of the freshly, coarsely powdered herbal drug, a 1000 mL round-bottomed flask, 10 drops of liquid paraffin R or other antifoam, 500 mL of water R as distillation liquid and 0.5 mL of xylene R in the graduated tube. Distil at a rate of 2-3 mL/min for 4 h.

Japanese Pharmacopoeia 16th Edition, 2011

GgeGinger (Zingbegiberis s Rhizomaoa) Description: Macroscopy, microscopy, organoleptic Identification: TLC against [6]-gingerol Purity: Heavy metals (NMT 10 ppm), Arsenic (NMT 5 ppm), Total ash (NMT 8.0%)

Powdered Ginger (Zingiberis Rhizoma Pulveratum) Description: Macroscopy, microscopy, organoleptic Identification: TLC against [6]- gingerol Purity: Heavy metals (NMT 10 ppm), Arsenic (NMT 5 ppm), Total ash (NMT 8.0%)

Processed Ginger (Zingiberis Processum Rhizoma) Description: Macroscopy, microscopy, organoleptic Identification: TLC against [6]- shogaol Purity: Arsenic (NMT 5 ppm), LOD (NMT 15.0%), Total ash (NMT 6.5%), Acid- insoluble ash (NMT 1.5%), Ethanol extractive (NLT 8.0%) The Korean Pharmacopoeia, 10th Edition, 2012

Ginger (Zingiberis Rhizoma) – Description: Macroscopic, microscopic, organoleptic – Identification: TLC against [6]-gingerol – Purity: Heavy metals (Lead, Arsenic, Mercury, Cadmium), Pesticides, Sulfur dioxide (NMT 30 ppm), Ash (NMT 8.0%) – Assay: Isocratic HPLC against [6]-gingerol, at 280 nm, (NLT 0.4%)

Chinese Pharmacopoeia 15th Edition, 2015

Dry Ginger (Zingiberis Rhizoma) – Description: Macroscopy, organoleptic – Identification: Microscopy, TLC against [6]-gingerol – Purity: Water content (NMT 19%), Total ash (NMT 6%), Water-soluble Extractives (NLT 22%) – Assay: HPLC against [6]-gingerol, at 280 nm (NLT 0.6%) Ginger Monographs in USP39-NF34, 2016

Ginger Identification: Turbidity with ammonium oxalate, blue color with and sulfuric acid, HPTLC against [6]-gingerol and [6]-shogaol Composition: Content of Gingerols and Gingerdiones against (NLT 0.8%) Contaminants: Elemental Impurities, Pesticides, Microbiology Specific tests: Macroscopy, Microscopy, Limit of Shogaols (NMT 0.18%), Alcohol-Soluble Extractives (NLT 4.5%), Starch (NLT 42%), Foreign Organic Matter (NMT 1 .0%) , Total Ash (NMT 8. 0%), Acid-Insoluble Ash (NMT 2 .0%) , Water -Soluble Ash (NLT 1.9%), Volatile Oil (NLT 1.8 mL/100g), Water-Soluble Extractives (NLT 10.0%), Water (NMT 10%)

Powdered Ginger Identification: Turbidity with ammonium oxalate, blue with vanillin and sulfuric acid, HPTLC against [6]-gingerol and [6]-shogaol Composition: Content of Gingerols and Gingerdiones against capsaicin (NLT 0.8%) Contaminants: Elemental Impurities, Pesticides, Microbiology Specific tests: Microscopy, Limit of Shogaols (NMT 0.18%), Alcohol-Soluble Extractives (NLT 4.5%), Starch content (NLT 42%), Total Ash (NMT 8.0%), Acid-Insoluble Ash (NMT 2.0%), Water-Soluble Ash (NLT 1.9%), Volatile Oil (NLT 1.8 mL/100g), Water-Soluble Extractives (NLT 10.0%), Water (NMT 10%)

Ginger Capsules Iden tificati on: Turbidit y w ith ammon ium oxa la te, blue w ith van illin an d su lfur ic ac id, HPTLC agaitinst [6]-gild[6]ingerol and [6]-shlhogaol Strength: Content of Gingerols, Gingerdiones and Shogaols against capsaicin (90.0–110.0%), Volatile Oil (NLT 1.4 mL/100g) Performance: Dissolution (NLT 60% of [6]-gingerol), Weight Variation

Ginger Tincture Identification: HPTLC against [6]-gingerol and [6]-shogaol Composition: Content of Gingerols against capsaicin (NLT 0.10%) Contaminants: Elemental Impurities, Pesticides, Microbiology Specific tests: Limit of Shogaols (NMT 0.034%), Limit of Nonvolatile Residue (NMT 0.5%), Specific Gravity (0.90 – 0.95)

Ginger Monographs in USP39-NF34, 2016 Ginger Monographs in USP39-NF34, 2016

Analytes Specified: 6-gingerol 8-gingerol A 6-shogaol 8-gingerol B 6-gingerdiol 6-gingerdione 10-gingerol 8-shogaol 8-gingerdione 10-shogaol

Reference Standards: USP Capsaicin RS USP Ginger Constituent Mixture RS USP Powdered Ginger RS

WHO Monographs on Selected Medicinal Herbs, Vol. 1, 1999

Rhizoma Zingiberis Description: General description of the plant Identity: Macroscopy, microscopy, organoleptic PitPurity: Microbi ol ogy, F orei gn matter (NMT 2 .0%) , T otal ash (NMT 6 .0%) , Ac id- insoluble ash (NMT 2.0%), Water-soluble extractives (NLT 10%), Alcohol- soluble extractives (NMT 4.5%), Pesticide residues, Heavy metals, Radioactive residues.

Note: Powdered ginger is frequently adulterated with exhausted ginger Compendium of Medicinal Plants Used in Malaysia, Vol. 2, 2002

Ginger ( Zingiberis Rhizoma)

Malaysian Pharmacopeia Name Corrected Name Synonymous to: Medicinal Use

1. Zingiber amaricans Noronha Zingiber amaricans Blume (L.) Roscoe ex Sm. Fever, gastralgia

2. Zingiber aromaticum Valeton Zingiber zerumbet (L.) Roscoe ex Sm Rheumatism, asthma

3. Roxb. (J.Koenig) Link ex A.Dietr. Carminative, stimulant

4. Zingiber chrysostachys Ridley Zingiber chrysostachys Ridl. Antipyretic

5. Zingiber griffithii Baker Poultice, anti-inflammatory

6. Zingiber officinale Roscoe Carminative, stimulant

7. Zingiber ottensii Valeton Sedative

8. Griff. Poultice, anti-inflammatory

9. Zingiber zerumbet (L.) Sm. Zingiber zerumbet (L.) Roscoe ex Sm. Antihypertensive, carminative

Ginger in Other Pharmacopeial Texts Dietary Supplements Containinggg Ginger – an Overview of US Market

Ginger Dietary Supplements in ODS DSLD Overview of Ginger Finished Products*

*Retrieved from iHerb in August 2016

Overview of Ginger Finished Products*

*Retrieved from iHerb in August 2016 Overview of Ginger Finished Products*

*Retrieved from iHerb in August 2016

Overview of Ginger Finished Products*

*Retrieved from iHerb in August 2016 Ginger Clinical Trials

Ginger Clinical Trials (www.clinicaltrials.gov), n=29

NCT01733212 Efficacy of Ginger on Intraoperative and Postoperative Nausea and Vomiting in Elective Cesarean Section Patients Completed NCT00958685 Safety Study of Feeding With Ginger Extract in Acute Respiratory Distress Syndrome Completed NCT02666807 Effects of Ginger Supplementation on NF‐KB in Peripheral Blood Mononuclear Cells in Type 2 Mellitus Completed NCT02742194 Ginger Capsules for the Chronic Treatment of Obesity Recruiting NCT02289235 The Effects of Ginger on Nonalcoholic Fatty Liver Disease Active, not recruiting NCT02491307 Ginger.io Behavioral Health Study Terminated Efficacy Study of Ginger (Zingiber Officinale) Extract "Ginpax" to Manage Nausea in Cancer Patients Receiving High Emetogenic NCT01887314 Treatments and Standard Anti‐emetogenic Therapy Completed NCT02735486 Acute Effects of Ginger Extract Consumption on Risk Markers of Cardiovascular Disease Completed NCT02570633 Ginger Capsules for the Prophylactic Treatment of Migraine Recruiting NCT02568644 Ginger Capsules for the Acute Treatment of Migraine Attacks Completed NCT02032251 Reduction of Sperm DNA Fragmentation by Oral Ginger Completed NCT01344538 Ginger for Prevention Completed NCT01429935 Anti Inflammatory and Analgesic Effect of Ginger Powder in Dental Pain Model Active, not recruiting NCT02701491 Effect of Ginger on Nausea and Vomiting During Acute Gastroenteritis in Children Recruiting NCT02390648 Efficacy of Ginger as an Adjunctive Prophylaxis for Chemotherapy‐induced Nausea and Vomiting Completed NCT00040742 Ginger in Treating Nausea in Patients Receiving Chemotherapy for Cancer Completed NCT00940368 A Study to Assess the Anti‐Emetic Efficacy of Ginger in Children and Adolescents Receiving Chemotherapy Recruiting NCT02809027 Efficacy of Ginger in the Prevention of Abdominal Distention in Post CesarCesareanean Section Patient Not yet recruiting NCT02576808 Study of Efficacy and Safety of Ginger Extract Compared With Loratadine for Treatment of Allergic Rhinitis Recruiting NCT00065221 Ginger Control of Chemotherapy Induced Nausea and Vomiting Completed NCT00064272 UMCCOP 02‐01 Ginger in Treating Nausea and Vomiting in Patients Receiving Chemotherapy for Cancer Completed NCT02213549 Effect of Coadministration of Ume Paste (Prunus Mume) and Ginger Powder Completed NCT01915966 Efficacy Study of a Ginger and Cardamom Gelatin for Xerostomy in Terminally Ill Patients Completed NCT02732379 Effect of on Postoperative Nausea, Vomiting and Quality of Recovery Recruiting NCT02535195 Effect of Ginger Supplement on Non‐alcoholic Fatty Liver Completed NCT00317655 Glucosamine Sulphate, Ginger, Ginger‐Avocado‐Soya and Ginger‐Ibuprofen for Chronic Back Pain Completed NCT00611156 Examination of the Effects of Four Different Spices on Energy Metabolism Completed NCT01085019 Impact of Spices and Herbs on Endothelial Function Completed NCT00537875 Evaluation of the Effect of Zingiber Officinalis on Nausea and Vomiting in Patients Receiving Based Regimens Completed Ginger Clinical Trials (www.clinicaltrials.gov), n=29

Ginger Pharmacology and Medicinal Uses Ginger Medicinal Uses

Pharmacology (WHO)

Cholagogic activity Intraduodenal administration of an extract (mainly essential oils) of ginger root to rats increased bile secretion for 3 hours after dosing. The active constituents of the essential oil were identified as [6]- and [10]-gingerol.

Antiemetic activity The antiemetic action of ginger has been attributed to the combined action of zingerones and shogaols.

Anti-inflammatory activity In vivo studies have shown that oral administration of ginger extracts decreased rat paw edema. The potency of the extracts was comparable to that of acetylsalicylic acid. [6]-Shogaol inhibited carrageenan-induced paw edema in rats by inhibiting cyclooxygenase activity. Medicinal uses (WHO)

Uses supported by clinical data The prophylaxis of nausea and vomiting associated with motion sickness, postoperative nausea, pernicious vomiting in pregnancy, and seasickness.

Uses described in pharmacopoeias and in traditional systems of medicine The treatment of dyspepsia, flatulence, colic, vomiting, diarrhea, spasms, and other stomach complaints. Powdered ginger is further employed in the treatment of colds and flu, to stimulate the appetite, as a narcotic antagonist, and as an anti- inflammatory agent in the treatment of migraine headache and rheumatic and muscular disorders.

Uses described in folk medicine, not supported by experimental or clinical data To treat cataracts, toothache, insomnia, baldness, and haemorrhoids, and to increase longevity.

Medicinal uses (EMA)

Ginger (Zingiberis rhizoma)

Spain Dried root powder hard-shell capsule 280 mg/capsule Dyspepsia, motion sickness

Austria Dried root powder hard-shell capsule 250 mg/capsule Motion sickness (kinetosis)

Germany Dried root powder hard-shell capsule 250 mg/capsule Motion sickness (kinetosis)

UK Dried root powder hard-shell capsule 250 mg/capsule Motion sickness, carminative Assessment Report on Zingiber officinale Roscoe, rhizoma

Ginger – Non-Clinical Data

–Antiemetic Gingerols and shogaols seem to be active components – Anti-inflammatory Gingerols and shogaols seem to be active anti-inflammatory components – Antioxidant The main pungent constituents, 6-gingerol and 6-shogaol, appear to be the main antioxidants – Antithrombotic Primarily 8-gingerol and 8-paradol, may be the major active principles that inhibit platelet activation – Hypolipidaemic The precise mechanism of action and the active constituents are not known – Hypoglycaemic This effect may partially be mediated through 6-gingerol and 6-shogaol – Cardiovascular There is presently not sufficient scientific evidence to suggest a cardiotonic or hypotensive effect – Antineoplastic The exact mechanisms of action are not known (6-gingerol ?) – Anti-infectious The mechanism of action has not been examined sufficiently – Thermogenic There is presently not sufficient scientific evidence to suggest a thermogenic effect (6-gingerol ?) – Analgesic There is presently not sufficient scientific evidence to suggest an analgesic effect (6-shogaol and 6-gingerol ?)

Pharmacology of Ginger Constituents

• Gingerols inhibit proliferation of cell line 10-gingerol > 8-gingerol > 6-gingerol (50-fold) • 6-Shogaol increased TRAIL-induced in renal carcinoma cells, an effect not observed with 6-gingerol • Zerumbone acts as anti-cancer in non-small cell lung, ovarian and cervical lymphoblastic and glioma. •New zerumbone derivatives are being developed and examined as anti-cancer agents, e.g., azazerumbone. Pharmacology of Ginger Constituents

Gastric Cancer: 6-gingerol induced apoptosis of gastric cancer cells; 6- shogaol also reduced the viability of gastric cancer cells by damaging microtubules; zerumbone inhibited cell proliferation, VEGF expression, and NF-ߢB activation : 6-gingerol, 6- shogaol, zerumbone Liver Cancer: 6-gingerol, 6-shogaol, zerumbone

Pharmacology of Ginger Constituents

In different GI cancers, ginger extract inhibits transcription factor NF-ߢB, inflammatory cytokine TNF-ߙ and other and proteins, which include xanthine oxidase and myeloperoxidase, MDA, HMG CoA reductase, free fatty acids, triglycerides, phospholipase A, and phospholipase C. The active ingredients of ginger, particularly, 6-gingerol and 6-shogaol target several cellular processes that contribute to tumorigenesis, cell survival, cell proliferation, invasion, and angiogenesis.

• 6-Gingerol modulates NF-ߢB, STAT3, Rb, MAPK, PI3K, Akt, ERK, cIAP1, cyclin A, Cdk, cathepsin D, and caspase -3/7. • 6-Shogaol targets NF-ߢB, STAT3, MAPK, PI3k/Akt Ca2+ signals, COX-2, cyclin D1, survivin, cIAP-1, XIAP, Bcl-2, MMP-9, caspase activation, ER stress, and eIF2ߙ. • Asian ginger component zerumbone modulates NF-ߢB, p53 VEGF, p21, and CXCR4 expression. Analyygtical Methods for Ginger Pungent Principles

Analytical Methods (LC-MS) Analytical Methods (LC-MS)

Analytical Methods (GC-MS)

[6]-Gingerol

[10]-Paradol

[6]-Gingerdiol Zingerone (E)-[6]-Shogaol Diacetoxy-[6]-gingerdiol ([0]-paradol) Methyl diacetoxy-[6]-gingerdiol [6]-Gingerdione 1-Dehydro-[6]-gingerdione [6]-Paradol [10]-Gingerdione [4]-Gingerol

(E)-[10]-Shogaol Analytical Methods (GC-MS)

Analytical Methods (GC-MS)

NNtote: GC AAtrtef acts t

Under GC conditions, gingerols are decomposed into zingerone, aldehydes, and shogaols. Analytical Methods (LC-UV)

“Amongst the 210 nm analyzed components 6- shogaol was found almost exclusively in 230 nm the extracts of the dietary supplement ginger sample”.

280 nm

310 nm

Analytical Methods (LC-UV)

282 nm 282 nm Analytical Methods (LC-UV)

200 nm

Analytical Methods (LC-UV)

1 – [6]-Gingerol 230 nm 2 – Methyl [6]-gingerol

3 – [8]-Gingerol

4 – Diacetoxy-[6]-gingerdiol Vietnam ginger 5 – [10]-Gingero l

6 – Acetoxy-[8]-gingerol

7 – Diacetoxy-[8]-gingerdiol

8 – 1-Dehydro-[8]-gingerdione

9 – Methyl diacetoxy-[8]-gingerdiol Analytical Methods (HPTLC, LC-UV)

280 nm

Fitness for Purpose Statement Proposed Fitness for Purpose

The method must quantitate the ‘pungent principles’ derived from the rhizome of ginger, Zingiber officinale Roscoe [Fam. Zingiberaceae].

The method must quantitate, at a minimum, [6]-, [8]- and [10]-gingerols, and [6]- shogaol.

The method should preferably quantitate [8]- and [10]-shogaols, as well as [6]-, [8]- and [10]-paradols, [6]- and [10]-gingerdiols, [6]-, [8]- and [10]-gingerdiones, and zingerone.

Individual constituents should be quantifiable within the range of 0.01% - 50% by weight in powdered ginger rhizome, ginger rhizome dry and soft extracts, and ginger-containing finished products, including capsules and tablets, in the presence of common excipients.

The ability to address softgels and tinctures is advantageous, yet optional.

No limit on analysis time is imposed.

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