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for Active Substance to be imported into European Union (EU).Iron Gluconate or Ferrous Gluconate Anhydrous and Dihydrate USP BP Ph Eur FCC Food Grade Manufacturers
Anmol Chemicals is a manufacturer supplier exporter of Iron Gluconate or Ferrous Gluconate Anhydrous and Dihydrate and it offers materials as per IP BP EP Ph Eur USP NF JP FCC Food Grade as per the the latest monograph at best prices. Anmol Chemicals Group, established in 1976, is the pioneer manufacturer of Specialty Chemicals, Pharmaceutical Excipients, Some API, Food Chemicals in India. Anmol Chemicals Group has manufacturing facilities spread across Western India, representatives in Houston, Chicago USA and Dubai, UAE. We also have toll manufacturing units for processing chemicals in a few countries around the world. We make IP, BP, EP, USP, NF, Ph. Eur., JP, FCC or Food Grade, Analytical Reagent Grade, LR or Laboratory Reagent Grades and Pure Grades of various chemicals. All our items are analyzed to meet the required standards. We can supply the product in grams for your laboratory trial and in tons for your plant scale jobs.
We manufacture Bulk Drugs / API, Excipients, Pharmaceuticals (IP BP USP NF Ph Eur EP JP), Specialty Chemicals (Pure/Reagent), Mineral Fortifiers (FCC). Our manufacturing facility is FDA approved and GLP, cGMP, ISO9001, ISO14001, ISO/IEC 17025, ISO22000, FSSC 22000, ISO45001, FSSAI, Kosher, HALAL, COPP, WHO-GMP certified and Written Confirmation (WC) is available. Solid materials can be customized for particle size, shape, and bulk density. We observe WHO Good Manufacturing Practices and Good Laboratory Practices. We are a government-recognized STAR Export House and "Authorised Economic Operator (AEO)" per Indian Customs.
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Iron Gluconate or Ferrous Gluconate SDS of Manufacturers
Synonyms: Iron Gluconate or Ferrous Gluconate Anhydrous and Dihydrate
CAS Number: 299-29-6 Anhydrous and 12389-15-0 Dihydrate, Molecular Weight: 446.15 Anhydrous, Chemical Formula: C12H22FeO14 Anhydrous, EINECS EC Number: ----, FEMA: ----,Ferrous Gluconate BP Grade Ph Eur
Ferrous GluconateDEFINITION
Iron (II) di(D-gluconate).
Content: 11.8 per cent to 12.5 per cent of iron(II) (dried substance). It contains a variable amount of water.CHARACTERS
Appearance: Greenish-yellow or grey powder or granules.
Solubility: Freely but slowly soluble in water giving a greenish-brown solution, more readily soluble in hot water, practically insoluble in ethanol (96 per cent).IDENTIFICATION
A. Thin-layer chromatography.
B. 1 ml of solution S (see Tests) gives reaction of iron.TESTS
Solution S: Dissolve 5.0 g in carbon dioxide-free water prepared from distilled water and heated to about 60C, allow to cool and dilute to 50 ml with carbon dioxide-free water prepared from distilled water.
Appearance of solution: The solution is clear.
pH: 4.0 to 5.5 for solution S, measured 3-4 h after preparation.
Sucrose and reducing sugars: To pass the test.
Chlorides: Maximum 0.06 per cent.
Oxalates: To pass the test.
Sulphates: Maximum 500 ppm.
Arsenic: Maximum 2 ppm, determined on 0.5 g.
Barium: To pass the test.
Ferric ion: Maximum 1.0 per cent.
Heavy metals: Maximum 20 ppm.
Loss on drying: 5.0 per cent to 10.5 per cent, determined on 0.500 g by drying in an oven at 105C for 5 h.
Microbial contamination: Total viable aerobic count not more than 103 micro-organisms per gram, determined by plate count.
Ferrous Gluconate USP Grade
C12H22FeO142H2O -- 482.17
D-Gluconic acid, iron(2+) salt (2:1), dihydrate.
Iron (2+) gluconate (1:2) dihydrate CAS 12389-15-0
Anhydrous 446.15 CAS 299-29-6Ferrous Gluconate contains not less than 97.0 percent and not more than 102.0 percent of C12H22FeO14, calculated on the dried basis.
Identification:
A: It responds to Identification test B under Calcium Gluconate.
B: A solution (1 in 200) yields a dark blue precipitate with potassium ferricyanide TS.
Loss on drying: Dry it at 105 for 16 hours: it loses between 6.5% and 10.0% of its weight.
Chloride: A 1.0-g portion shows no more chloride than corresponds to 1.0 mL of 0.020 N hydrochloric acid (0.07%).
Oxalic acid: Dissolve 1.0 g in 10 mL of water, add 2 mL of hydrochloric acid, and transfer to a separator. Extract successively with 50 mL and 20 mL of ether. Combine the ether extracts, add 10 mL of water, and evaporate the ether on a steam bath. Add 1 drop of 6 N acetic acid and 1 mL of calcium acetate solution (1 in 20): no turbidity is produced within 5 minutes.
Sulfate: A 1.0-g portion shows no more sulfate than corresponds to 1.0 mL of 0.020 N sulfuric acid (0.1%).
Arsenic: he limit is 3 ppm.
Limit of ferric iron: Ferrous Gluconate contains not more than 2.0% of ferric iron.
Limit of lead: To pass the test by atomic absorption spectrophotometer. (0.001%).
Mercury: 3 ppm.
Reducing sugars: to pass the test.
Ferrous Gluconate FCC Food Grade
Iron (II) Gluconate
C12H22FeO14-2H2O --- Formula weight 482.18
INS: 579 ---CAS: 299-29-6DESCRIPTION
Ferrous Gluconate occurs as a fine, yellow-gray or pale green-yellow powder or granules. One gram dissolves in about 10 mL of water with slight heating. It is practically insoluble in
alcohol. A 1:20 aqueous solution is acid to litmus.
Function: Nutrient; color adjunct.REQUIREMENTS
Identification:
A. Dissolve a quantity of sample in water, heating in a water bath at 60C if necessary, to obtain a Test Solution containing 10 mg/mL. Similarly, prepare a Standard Solution of USP Ferrous Gluconate Reference Standard in water, diluting to 10 mg/mL. Apply separate 5- L portions of the Test Solution and the Standard Solution on a suitable thin-layer chromatographic
plate 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 110C for 20
minutes 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 110C for about 10 minutes The principal spot obtained from the Test Solution corresponds in color, size, and Rf value to that obtained from the Standard Solution.
B. A 1:20 aqueous solution gives positive tests for Ferrous Salts (Iron).
Assay: Not less than 97.0% and not more than 102.0% of C12H22FeO14, calculated on the dried basis.
Chloride: Not more than 0.07%.
Ferric Iron: Not more than 2.0%.
Lead: Not more than 2 mg/kg.
Loss on Drying: Between 6.5% and 10.0%.
Mercury: Not more than 3 mg/kg.
Oxalic Acid: To pass the test.
Reducing Sugars: To pass the test.
Sulfate: Not more than 0.1%.Keywords: Iron Gluconate or Ferrous Gluconate Anhydrous and Dihydrate IP BP Ph Eur EP USP Analytical Reagent FCC Food Grade CAS Number 299-29-6 Anhydrous 12389-15-0 Dihydrate Manufacturer Supplier Exporter Monograph Uses Chemical Molecular Formula Weight.
Manufacturer Supplier Exporter
ANMOL CHEMICALS
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Taloja Navi Mumbai, INDIAe-mail: info@anmol.org
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