FCCV标准-Zinc Gluconate葡萄糖酸锌.pdf

FCC VMonographs Zinc Gluconate 511 TESTS Assay Protein Determine as directed under Nitrogen De termination Appendix IIIC Calculate the percent protein P by the equation P 6 25N in which N is the percent nitrogen Amino Nitrogen Total Nitrogen AN TN Percent Ra tioDetermine Amino Nitrogen as directed under Amino Nitrogen Determination Appendix IIIC Determine Total Ni trogen as directed under Nitrogen Determination Appendix IIIC Calculate the AN TN percent ratio in which AN is the percent of amino nitrogen and TN is the percent of total nitrogen Ammonia NitrogenDetermine as directed under Ammonia Nitrogen Appendix IIIC Glutamic AcidDetermine as directed under Glutamic Acid Appendix IIIC Insoluble MatterTransfer about 5 g of sample accurately weighed into a 250 mL Erlenmeyer flask add 75 mL of water cover the flask with a watch glass and boil gently for 2 min Filter the solution through a tared filtering crucible dry at 105 for 1 h cool and weigh LeadDetermineasdirectedintheFlameAtomicAbsorption Spectrophotometric Method under Lead Limit Test Appendix IIIB using a 10 g sample MercuryDetermine as directed under Mercury Limit Test Appendix IIIB Microbial Limits Note Current methods for the following tests may be found online at Aerobic Plate Count Coliforms Salmonella Yeasts and Molds PotassiumProceed as directed in the monograph for Yeast Autolyzed Sodium ChlorideProceed as directed in the monograph for Yeast Autolyzed except to use 50 0 mg of reagent grade sodium chloride to prepare the Standard Solution Packaging and StorageStore in well closed containers Zein CAS 9010 66 6 DESCRIPTION Zein occurs as a very light yellow to tan colored granular or fine powder It comprises the prolamine protein component of corn Zea mays Linne It is produced commercially by extraction from corn gluten with alkaline aqueous isopropyl alcohol The extract is then cooled which causes the Zein to precipitate It is insoluble in water FunctionSurface finishing agent texturizing agent REQUIREMENTS Identification A Dissolve about 0 1 g of sample in 10 mL of 0 1 N sodium hydroxide and add a few drops of cupric sulfate TS Warm in a water bath A purple color appears B Add 1 mL of nitric acid to a test tube containing 25 mg of sample Agitate vigorously The solution turns light yellow Further addition of about 10 mL of 6 N ammonium hydroxide produces an orange color AssayNotlessthan88 0 andnotmorethan96 0 protein calculated on the dried basis LeadNot more than 2 mg kg Loss on DryingNot more than 8 0 Loss on IgnitionNot more than 2 TESTS AssayDetermineasdirectedunderNitrogenDetermination Appendix IIIC Calculate the percent protein P by the equation P 6 25N in which N is the percent nitrogen LeadDetermineasdirectedintheFlameAtomicAbsorption Spectrophotometric Method under Lead Limit Test Appendix IIIB using a 10 g sample Loss on DryingDetermine as directed under Loss on Dry ing Appendix IIC drying a 2 g sample in an air oven at 105 for 2 h Loss on IgnitionDetermine as directed under Ash Total Appendix IIC using a 2 g sample Packaging and StorageStore in well closed containers Zinc Gluconate O ZnHO H OH O HOH OH OHHH H OHHO H OHOHHH O O OH C12H22O14ZnFormula wt 455 68 CAS 4468 02 4 DESCRIPTION Zinc Gluconate occurs as a white or nearly white granular or crystalline powder and as a mixture of various states of 512 Zinc Oxide MonographsFCC V hydration up to the trihydrate depending on the method of isolation It is freely soluble in water and very slightly soluble in alcohol FunctionNutrient REQUIREMENTS LabelingIndicate the powder or granular form of the product Identification A A 1 10 aqueous solution gives positive tests for Zinc Appendix IIIA B Dissolveaquantityofsampleinwater heatinginawater bath at 60 if necessary to obtain a Test Solution containing 10 mg mL Similarly prepare a Standard Solution of USP Potassium Gluconate Reference Standard in water diluting to 10 mg mL Apply separate 5 L portions of the Test Solu tion and the Standard Solution on a suitable thin layer chro matographic plate see Thin Layer Chromatography Appen dix IIA coated with a 0 25 mm layer of chromatographic silica gel and allow to dry Develop the chromatogram in a solvent system consisting of a mixture of alcohol water ammonium hydroxide and ethyl acetate 50 30 10 10 until the solvent front has moved about three fourths of the length of the plate Remove the plate from the chamber and dry at 110 for 20 min Allow to cool and spray with a spray reagent prepared as follows Dissolve 2 5 g of ammonium molybdate in about 50 mL of 2 N sulfuric acid in a 100 mL volumetric flask add 1 0 g of ceric sulfate swirl to dissolve dilute with 2 N sulfuric acid to volume and mix After spraying heat the plate at 110 for about 10 min The principal spot obtained from the Test Solution corresponds in color size and Rfvalue to that obtained from the Standard Solution AssayNot less than 97 0 and not more than 102 0 of C12H22O14Zn calculated on the anhydrous basis CadmiumNot more than 2 mg kg ChlorideNot more than 0 05 LeadNot more than 2 mg kg Reducing SubstancesNot more than 1 0 SulfateNot more than 0 05 WaterNot more than 11 6 TESTS AssayDissolve about 700 mg of sample accurately weighed in 100 mL of water warming if necessary to aid dissolution and add 5 mL of ammonia ammonium chloride buffer TS and 0 1 mL of eriochrome black TS Titrate with 0 05 M disodium EDTA until the solution turns blue Each milliliter of 0 05 M disodium EDTA is equivalent to 22 78 mg of C12H22O14Zn CadmiumDetermine as directed under Cadmium Limit Test Appendix IIIB ChlorideDetermine as directed in the Chloride Limit Test under Chloride and Sulfate Limit Tests Appendix IIIB Any turbidity produced by a 40 mg sample does not exceed that shown in a control containing 20 g of chloride Cl ion LeadDetermineasdirectedintheFlameAtomicAbsorption Spectrophotometric Method under Lead Limit Test Appendix IIIB using a 5 g sample Reducing SubstancesTransfer about 1 g of sample accu rately weighed into a 250 mL Erlenmeyer flask dissolve in 10 mL of water and add 25 mL of alkaline cupric citrate TS Cover the flask with a small beaker boil gently for exactly 5 min and cool rapidly to room temperature Add 25 mL of a 1 10 acetic acid solution 10 0 mL of 0 1 N iodine 10 mL of 2 7 N hydrochloric acid and 3 mL of starch TS and titrate with 0 1 N sodium thiosulfate to the disappearance of the blue color Calculate the weight in milligrams of reducing substances asD glucose by the formula 27 V1N1 V2N2 in which 27 is an empirically determined equivalence factor forD glucose V1and N1are the volume in milliliters and the normality of the iodine solution respectively and V2and N2are the volume in milliliters and the normality of the sodium thiosulfate solution respectively SulfateDetermineasdirectedintheSulfateLimitTestunder ChlorideandSulfateLimitTests AppendixIIIB Anyturbidity producedbya500 mgsampledoesnotexceedthatinacontrol containing 250 g of sulfate SO4 ion Wa