Roc iy 270 / Cardamom Gil / Monographs ‘00 Fec 19 wavenumbers (em) ‘Cardamom. ee Carmine First Published: Prior to FCC 6 Ccarminic Acid ory on wy - CatinOw Formula we 492.39 Ns. "120 CAS! (1390-65-4] UNI: TZBZ31835M [cochineal] DESCRIPTION Carmine occurs as bright red, friable pieces or as a dark red powder. Iti the aluminum or the calcium-aluminum fake, Shan aluminum hydroxide substrate, of the coloring principles obtained by an aqueous extraction of cochinea Cochineal consists of the dried female insects Dactylopius coccus costa (Coccus cacti .), enclosing young larvae; the Coloring principles thus derived consist mainly of catminic Seid (CasHasO1). It is soluble in alkali solutions, slightly Soluble in hot water, and practically insoluble in cold water and in dilute acids. Carminic acid crystallizes from water as bright red crystals ‘hat darken at 130° and decompose at 250°; its freely Soluble in water, in alcohol, in ether, in concentrated Sulfuric acid, and in solutions of alkali hydroxides; i is, insoluble in petroleum ether and in chloroform. Its aque solutions at pH 4.8 ate red-orange to yellow, and at 6.2 are dark red to violet. [NoTE—Before use in food, Carmine must be pasteurized of otherwise treated to destroy all viable Salmonella microorganisms. According to the pertinent U.S. color additive regulation (21 CFR 73.100(b)@2), ".. pasteurization or such other treatment js deemed to perm The adding of safe and suitable substances (other than chemical preservatives) that are essential to the method: pasteurization or other treatment used.”"] {Note—The specifications and tests in this monograph ref to Carmine without any added substances for pasteurization or any other such treatment] Funetion: Color Packaging and Storage: Store in wel-losed containers in a cool, dry place. IDENTIFICATION : ROCEDURE ‘Semple solution: Mix 333 mg of sample with 44 ml | ‘water, 0.15 mL of @ 1:10 sodium hydroxide solution, ‘and 0.2 mL of ammonium hydroxide in a 500ml Volumetric flask. Warm the mixture to dissolve the sample, allow the solution to cool, dilute to volume ‘with water, and mix. Pipet 10.0 mL of this solution inte 2 250-mL. volumetric flask, dilute to volume with wate: and mix. Analysis: Using a suitable spectrophotometer and a 1 ‘cm cell, measure the absorbance of the Sample solutior use water as a blank. in Ti ii) Acceptance criteria: The Sample solution exhibits Mporption maxima at 520 nm and SSO nm and the Spsorbance at 520 nm is not les than 0.30. SAY. (0.100 g (-52% carminic acid content) jolution: Dissolve the Sample in 30 ml of 2N “iydrochloric acid and heat to a boil for 30's. After Boling, dilute to a volume of one liter. if a black or brown precipitate forms, fiter the solution, alysis: Using a suitable spectrophotometer and a 1- Tem call, measure the absorbance of the Sample solution it the wavelength maximum of about 494 nm; use a ‘aqueous dilution of 2.N hydrochloric acid as the fank. [NoTE—To obtain accurate results, the ince must be in the range of 0.650 to 0.750. tthe starting weight as necessary to achieve this ince_] Calculate the percent carminic acid in the smple taken by the formula: = 1004/13.9W Resul bsorbance of the Sample solution "weight of the sample taken (g) LT 50.0% of carminic acid imple: 3.0.9 mple solution: Transfer the Sample into a SO0-mt | fask equipped with a steam trap, add 5.9 of sulfate and 75 mL of hydrochloric acid, and “ix, Connect the flask with the steam trap and with a fener, the delivery tube of which consists of a ized straight adapter and extends to slightly the bottom of a 500-ml. Erlenmeyer flask ining 100 mL of water. Begin heating the Kjeldahl ‘and collect about 40 mL of dstilate in the yer flask. Pour the distillate mixture into a 600- beaker, and add 20 ml of bromine TS (bromine ),and heat on a hot plate until the volume is dito about 2 mL. Transfer the residual liquid into emi. arsine generator flask (see Figure 11) with fe aid of 35 mL of water, and continue as directed in fe Procedure beginning with “Add 20 ml. of 1:5 ie acid.” Kceptance criteria: NMT 1 mg/kg ead Limit Test, Appendix IIB mple solution: Prepare as directed for organic nds. 2g Pb (2 mi. of Diluted Standard Lead on) tance crite NMT 2 mg/kg Monographs / Carnauba Wax / 271 ‘Analysis: Transfer the Sample into a tared, previously ignited and cooled porcelain crucible, and ignite red- hhot with a Meker burner to constant weight. Acceptance criteria: NVT 12.0% ‘+ Loss on Drvinc, Appendix IC: 135° for 3h ‘Sample: 1g ‘Acceptance criteria: ‘+ MicrosiaL Liwrs [Nore—Current methods for the following tests may be found by accessing the US Food and Drug ‘Administration's Bacteriological Analytical Manual (BAM) online at wwwfda.gov/Food/default.htm.} Acceptance criteria Salmonella: Negative in 25.9 ‘= PRoTEM, Nitrogen Determination, Method 1, Appendix IC ‘Analysis: Calculate the protein content, in percent, by the forrmula: NMT 20.0% Result = (F x N/W) x 100 F = conversion factor from nitrogen to protein, 6.25 N= weight of nitrogen (mg) weight of sample taken (mg) ‘Acceptance criteria: NMT 25% Carnauba Wax First Published: Prior to FCC 6 INS: 903 CAS: [8015-869] UNII: RIZCBMOEIZ [carnauba wax] DESCRIPTION CCarmauba Wax accurs as a hard, brittle substance with a Tesinous fracture and a color ranging from light brown to pale yellow. It is a purified wax obtained from the leaf bbuds and leaves of the Brazilian wax palm Copemicia cereferia (Arruda) Mart. [synonym C. prunifera (Muell.]. Its specific gravity is about 0.997. It is partially soluble in boiling alcohol, is soluble in chloroform and in ether, but is insoluble in water. Function: Anticaking agent; surface-finishing (glazing) agent; release agent; carrier for flavors Packaging and Storage: Store in wellciosed containers IMPURITIES Inorganic Impurities + Leap, Appendix IB Sample solution: Prepare as directed for organic compounds. Control: 5 ug Po (5 mL. of Diluted Standard Lead Solution) ‘Acceptance criteria: NMT 5 mg/kg SPECIFIC TESTS Act VALUE [FATS AND RELATED SUBSTANCES], Method |, ‘Appendix Vil Acceptance criteria: Between 2 and 7