Residue Monograph prepared by the meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA), 82 nd meeting 2016.

Similar documents
Residue Monograph prepared by the meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA), 82 nd meeting 2016.

1 out of 8. Residue Monograph prepared by the meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA), 86th Meeting 2018 ERYTHROSINE

Residue Monograph prepared by the meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA), 82 nd meeting 2016.

Lutein Esters from Tagetes Erecta

Rebaudioside a From Multiple Gene Donors Expressed in Yarrowia Lipolytica

Jagua (Genipin-Glycine) Blue (Tentative)

PAPRIKA EXTRACT SYNONYMS DEFINITION DESCRIPTION FUNCTIONAL USES CHARACTERISTICS

ISOMALT. Chemical formula 6-O-alpha-D-Glucopyranosyl-D-sorbitol: C 12 H 24 O 11 1-O-alpha-D-Glucopyranosyl-D-mannitol dihydrate: C 12 H 24 O 11 2H 2 O

Steviol Glycosides from Stevia rebaudiana Bertoni

TENOFOVIR TABLETS: Final text for addition to The International Pharmacopoeia (June 2010)

Sucrose Esters of Fatty Acids

The Amendment of Standards for Specification, Scope, Application and Limitation of Food Additives

Tenofovir disoproxil fumarate (Tenofoviri disoproxili fumaras)

SUCROSE OLIGOESTERS TYPE I

FAO 2017 BRILLIANT BLUE FCF. Chemical and Technical Assessment (CTA) Prepared by Julie N. Barrows, Ph.D., and reviewed by Eugenia Dessipri, Ph.D.

β-carotene-rich Extract From Dunaliella Salina

ARTENIMOLUM ARTENIMOL. Adopted revised text for addition to The International Pharmacopoeia

THERMALLY OXIDIZED SOYA BEAN OIL interacted with MONO- and DIGLYCERIDES of FATTY ACIDS

ARTESUNATE TABLETS: Final text for revision of The International Pharmacopoeia (December 2009) ARTESUNATI COMPRESSI ARTESUNATE TABLETS

THERMALLY OXIDIZED SOYA BEAN OIL

Hydroxypropyl Starch (Tentative)

INTERNATIONAL PHARMACOPOEIA MONOGRAPH ON LAMIVUDINE TABLETS

Methotrexate. (Ph. Eur. monograph 0560) C 20 H 22 N 8 O Action and use. Dihydrofolate reductase inhibitor; cytostatic.

CYCLOSERINE Proposal for revision of The International Pharmacopoeia (August 2012)

Title Revision n date

Pectins. Residue Monograph prepared by the meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA), 82 nd meeting 2016

TENOFOVIRI DISOPROXILIS FUMARAS TENOFOVIR DISOPROXIL FUMARATE

The Draft Amendment of Standards for Specification, Scope, Application and Limitation of Food Additives

RITONAVIRI COMPRESSI RITONAVIR TABLETS. Final text for addition to The International Pharmacopoeia (July 2012)

DRAFT PROPOSAL FOR THE INTERNATIONAL PHARMACOPOEIA: CARBAMAZEPINI COMPRESSI - CARBAMAZEPINE TABLETS

ABACAVIR SULFATE Proposal for revision of The International Pharmacopoeia (August 2012)

Quetiapine Tablets. Expert Committee Monographs Chemical Medicines 4 Reason for Revision Compliance

ASSAY AND IMPURITY METHOD FOR DURACOR TABLETS BY HPLC

This revision also necessitates a change in the table numbering in the test for Organic Impurities.

Yeast Extracts containing Mannoproteins (Tentative)

IJPAR Vol.3 Issue 4 Oct-Dec-2014 Journal Home page:

Revision of monograph in the 4 th Edition of The International Pharmacopoeia (August 2008)

The International Pharmacopoeia TENOFOVIR DISOPROXIL FUMARATE (JULY 2012)

Purity Tests for Modified Starches

REVISED DRAFT MONOGRAPH FOR THE INTERNATIONAL PHARMACOPOEIA RETINOL CONCENTRATE, OILY FORM. (August 2010)

Draft proposal for The International Pharmacopoeia

CYCLOSERINI CAPSULAE - CYCLOSERINE CAPSULES (AUGUST 2015)

PROPOSAL FOR REVISION OF MONOGRAPH IN THE FOURTH EDITION OF The International Pharmacopoeia MEFLOQUINE HYDROCHLORIDE (JANUARY 2012) DRAFT FOR COMMENT

DEVELOPMENT AND VALIDATION OF RP-HPLC METHOD ESTIMATION OF TOLVAPTAN IN BULK PHARMACEUTICAL FORMULATION

RP-HPLC Method Development and Validation of Abacavir Sulphate in Bulk and Tablet Dosage Form

Draft monograph for inclusion in. The International Pharmacopoeia. Dextromethorphani solutionum peroralum - Dextromethorphan oral solution

Flupyradifurone. HPLC Method

DEVELOPMENT AND VALIDATION OF RP-HPLC METHOD FOR ESTIMATION OF LACOSAMIDE IN BULK AND ITS PHARMACEUTICAL FORMULATION

The Nitrofurantoin Capsules Revision Bulletin supersedes the currently official monograph.

10 Sulfaquinoxaline H N O S O. 4-amino-N-quinoxalin-2-ylbenzenesulfonamide C 14 H 12 N 4 O 2 S MW: CAS No.:

ISOMALT. Stage 4. C 12 H 24 O 11 M r C 12 H 24 O 11, 2H 2 O M r DEFINITION

FLUNITRAZEPAM Latest Revision: January 24, 2006

HEPARIN SODIUM. Heparinum natricum

Analytical Method for 2, 4, 5-T (Targeted to Agricultural, Animal and Fishery Products)

An Investigative Study of Reactions Involving Glucosinolates and Isothiocyanates

PROPOSAL FOR REVISION OF MONOGRAPH PUBLISHED IN The International Pharmacopoeia: REVISION OF ph test ABACAVIR ORAL SOLUTION (JULY 2012)

Electronic Supporting Information

Analytical and Preparative SFC Columns

CLINDAMYCIN PHOSPHATE (CLINDAMYCINI PHOSPHAS) REVISED DRAFT MONOGRAPH FOR INCLUSION IN The International Pharmacopoeia (August 2016)

ZIDOVUDINE, LAMIVUDINE AND ABACAVIR TABLETS Draft proposal for The International Pharmacopoeia (September 2006)

Tramadol Hydrochloride Extended-Release Tablets. Expert Committee Chemical Medicines Monographs 2 Reason for Revision Compliance

LYCOPENE FROM BLAKESLEA TRISPORA CHEMICAL AND TECHNICAL ASSESSMENT (CTA)

STANDARD OPERATING PROTOCOL (SOP)

EUDRAGIT E 100, EUDRAGIT E PO and

ABSINTHIUM FOR HOMOEOPATHIC PREPARATIONS ABSINTHIUM FOR HOMOEOPATHIC PREPARATIONS

Amendment of Standards for Specification, Scope, Application and Limitation of Food Additives

contents of the monograph in effect today. Please refer to the current edition of the USP NF for official text.

RP- HPLC and Visible Spectrophotometric methods for the Estimation of Meropenem in Pure and Pharmaceutical Formulations

Impurity Profiling of Carbamazepine by HPLC/UV

ANALYSIS OF -HYDROXYBUTYRATE (GHB) AND -BUTYROLACTONE (GBL) IN LIQUIDS PERFORMED AT NATIONAL LABORATORY OF FORENSIC SCIENCE (SKL), SWEDEN

SUMMARY, CONCLUSION & RECOMMENDATIONS

Analysis of HMF by HPLC

Asian Journal of Pharmaceutical Analysis and Medicinal Chemistry Journal home page:

CHAPTER-6 IDENTIFICATION, AND CHARACTERISATION OF DEGRADATION IMPURITY IN VALSARTAN TABLETS

ABSINTHIUM FOR HOMOEOPATHIC PREPARATIONS ABSINTHIUM FOR HOMOEOPATHIC PREPARATIONS

DRAFT MONOGRAPH FOR THE INTERNATIONAL PHARMACOPOEIA PAEDIATRIC RETINOL ORAL SOLUTION (August 2010)

OLEANDER FOR HOMOEOPATHIC PREPARATIONS NERIUM OLEANDER FOR HOMOEOPATHIC PREPARATIONS

PHCH 402: Analytical Quality Control Different methods of analysis of some groups of drugs in common use in Nigeria (8 hrs)

CLINDAMYCIN PALMITATE

Sepax Technologies, Inc.

SMOKE FLAVOURINGS. Wood smoke flavour, Smoke condensate

Relative Measurement of Zeaxanthin Stereoisomers by Chiral HPLC

COMMISSION DIRECTIVE 2011/3/EU

DRAFT MONOGRAPH FOR THE INTERNATIONAL PHARMACOPOEIA EFAVIRENZ, EMTRICITABINE AND TENOFOVIR TABLETS

SIMAROUBA CEDRON FOR HOMOEOPATHIC PREPARATIONS CEDRON FOR HOMOEOPATHIC PREPARATIONS

Continuation of Reversed-Phase HPLC Analysis Studies of Steviol Glycosides Isolated From Stevia rebaudiana Bertoni

SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLETS Draft proposal for The International Pharmacopoeia (September 2010)

Compliance. Should you have any questions, please contact Behnaz Almasi, Associate Scientific Liaison ( or

Application Note Soy for Isoflavones by HPLC. Botanical Name: Glycine max L. Common Names: Parts of Plant Used: Beans.

Revision Bulletin 28 Jul Aug 2017 Chemical Medicines Monographs 3

Journal of Pharmacreations

Journal of Chemical and Pharmaceutical Research

CHAPTER 8 HIGH PERFORMANCE LIQUID CHROMATOGRAPHY (HPLC) ANALYSIS OF PHYTOCHEMICAL CONSTITUENTS OF M. ROXBURGHIANUS AND P. FRATERNUS PLANT EXTRACTS

Draft Indian Standard SODIUM HYDROXIDE, FOOD GRADE SPECIFICATION

Analytical Method Development for USP Related Compounds in Paclitaxel Using an Agilent Poroshell 120 PFP

Available online Research Article

Revision Bulletin 23 Feb Mar 2018 Chemical Medicines Monographs 3 Compliance

Available online Research Article

PROPOSAL FOR REVISION OF MONOGRAPH PUBLISHED IN THE FOURTH EDITION OF The International Pharmacopoeia

Transcription:

Residue Monograph prepared by the meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA), 82 nd meeting 2016 Quinoline Yellow This monograph was also published in: Compendium of Food Additive Specifications. Joint FAO/WHO Expert Committee on Food Additives (JECFA), 82 nd meeting 2016. FAO JECFA Monographs 19

1 of 5 QUINOLINE YELLOW Prepared at the 82 nd JECFA (2016) and published in FAO JECFA Monograph 19 (2016), superseding tentative specifications prepared at the 74 th JECFA (2011) and published in FAO JECFA Monographs 11 (2011). An ADI of ADI of 0 3 mg/kg bw was established at the 82nd JECFA (2016). SYNONYMS INS No. 104; CI Food Yellow 13; CI (1982) No. 47005 DEFINITION Quinoline Yellow is manufactured by sulfonating 2-(2-quinolyl)-1,3- indandione. It consists predominantly of sodium salts of disulfonates of 2- (2-quinolyl)-1,3-indandione with smaller amounts of monosulfonates and trisulfonates; and subsidiary colouring matters, sodium chloride and/or sodium sulfate. Quinoline Yellow may be converted to the corresponding aluminium lake, in which case only the General Specifications for Aluminium Lakes of Colouring Matters apply. Chemical name C.A.S. number Chemical formula Structural formula Disodium 2-(2-quinolyl)indan-1,3-dionedisulphonate (principal component) 80583-08-0 (principal component) C 18H 9NO 8S 2Na 2 (principal component) (Principal component) (NaO 3 S) 2 N O O Formula weight Assay DESCRIPTION 477.38 (Principal component) Not less than 70% total colouring matters. Of the total colouring matters present: - not less than 80% of disodium 2-(2-quinolyl)-indan-1,3-dionedisulfonates; - not more than 15% of sodium 2-(2-quinolyl)-indan-1,3-dionemonosulfonates; - not more than 7% of trisodium 2-(2-quinolyl)-indan-1,3-dione-trisulfonate Yellow powder or granules

2 of 5 FUNCTIONAL USES Colour CHARACTERISTICS IDENTIFICATION Solubility Spectrophotometry (Vol.4) Freely soluble in water; sparingly soluble in ethanol The UV-visible absorption spectrum of an aqueous solution of the sample shows a maximum wavelength approximately at 414 nm. PURITY Loss on drying at 135 o, chloride and sulfate as sodium salts Water-insoluble matter Subsidiary colouring matters Organic compounds other than colouring matters Unsulfonated primary aromatic amines Not more than 30% Determine according to Loss on drying in Volume 4 (under Specific Methods, Food Colours ). Not more than 0.2% Not more than 4 mg/kg of 2-(2-quinolyl)-1,3-indandione and 2-[2-(6- methylquinolyl)]-1,3-indandione See description under TESTS Not more than 0.5%, sum of 2-methylquinoline, 2- methylquinolinesulfonic acid and phthalic acid See description under TESTS Not more than 0.01% calculated as aniline Ether-extractable matter Not more than 0.2% Lead Zinc Not more than 2 mg/kg Determine using a method appropriate to the specified level. The selection of sample size and method of sample preparation may be based on the principles of the method described in Volume 4 (under General Methods, Metallic Impurities ). Not more than 50 mg/kg Determine using a method appropriate to the specified level. The selection of sample size and method of sample preparation may be based on the principles of the method described in Volume 4 (under General Methods, Metallic Impurities ).

3 of 5 TESTS PURITY TESTS Subsidiary colouring matters Determine 2-(2-quinolyl)-1,3-indandione and 2-[2-(6-methyl-quinolyl)]- 1,3-indandione by reversed-phase HPLC (Vol.4) using the following conditions: Solvent A: 0.05 M ammonium acetate Solvent B; acetonitrile Injection volume: 100 μl Column: C18 (250 mm x 4.6 mm i.d., 5 µm particle size) Detector: UV-Vis/PDA at 436 nm Flow rate: 1 ml/min Gradient: Min %A %B 0 40 60 19.9 40 60 20.0 0 100 35.0 0 100 Standards: 2-(2-quinolyl)-1,3-indandione, Sigma 01354 or equivalent; 2- [2-(6-methyl-quinolyl)]-1,3-indandione, Chemos GmbH or equivalent. Sample preparation: Dissolve 1 g of sample in 10 ml of hot water. Allow solution to cool to room temperature. Extract analytes using chloroform, evaporate the solvent and dissolve the residue in acetonitrile. Organic compounds other than colouring matters Determine sum of 2-methylquinoline, 2-methylquinolinesulfonic acid and phthalic acid by reversed-phase HPLC (under Specific Methods, Food Colours ) using the following conditions: Solvent A: 0.2 M ammonium acetate in water/methanol (95:5, v/v) Solvent B: methanol Injection volume: 20 μl Detector wavelength: UV/PDA at 254 nm Flow rate: 1 ml/min Gradient: Min %A %B 0 100 0 8.8 80 20 9.0 0 100 12.0 0 100 Note: A general gradient for the separation of organic compounds other than colouring matters in several food colours is given in Vol. 4. The above gradient may be use for the analytes in Quinoline Yellow. Standard solution: 0.1% of quinaldine-6-sulfonic acid, quinaldine-6,8- disulfonic acid, trisodium salt of 4-sulfophthalic acid and 3-sulfophthalic acid in Solvent A

4 of 5 Sample solution: 100 mg (± 5 mg) of sample in 10 ml of water METHOD OF ASSAY Determine total colouring matters using Procedure 1 in Volume 4 (under Specific Methods, Food Colours ) and mono-, di- and trisulfonates of 2- (2-quinolyl)-indan-1,3-dione by reversed-phase HPLC (Vol.4). Total colouring matters Solvent: Water Absorptivity (a) = 87.9 L/(g cm) Wavelength of maximum absorbance = 414 nm Mono-, di- and trisulfonates Determine sodium salts of mono-, di- and trisulfonates of 2-(2-quinolyl)- indan-1,3-dione by reversed-phase HPLC using the following conditions: Solvent A: 0.1 M ammonium acetate in water/methanol (95:5, v/v) Solvent B: methanol Injection volume: 20 μl Column: Hypersil RP C8 (250 mm x 4.6 mm i.d.,5 µm particle size) or equivalent. Column temperature: 25 º Detector: UV-Vis/PDA at 414 nm Flow rate: 1 ml/min Gradient: Min %A %B 0 90 10 30 0 100 Standard solution (for retention times): 10 mg of Quinoline Yellow containing mono-, di-, and trisulfonates in 100 ml of water/methanol (75:25). Sample solution: 10 mg of sample in 100 ml of water/methanol (75:25). Calculation: Express the results as percentage of the peak area of each components/the peak area of total peaks on the chromatogram.

5 of 5 Appendix Typical HPLC chromatogram of Quinoline Yellow Time (min) mono-sa: sodium 2-(2-quinolyl)-indan-1,3-dione-monosulfonates di-sa: disodium 2-(2-quinolyl)-indan-1,3-dione-disulfonates tri-sa: trisodium 2-(2-quinolyl)-indan-1,3-dione-trisulfonate [Reference] A. Weisz, E. P. Mazzola, and Y. Ito, Preparative Separation of Di- and Trisulfonated Components of Quinoline Yellow Using Affinity-Ligand ph-zone-refining Counter-Current Chromatography, J. Chromatography A, 1216, 4161-4168 (2009).