Gum Tragacanth USP NF BP Ph Eur FCC Food Grade Manufacturers

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Gum Tragacanth USP NF BP Ph Eur FCC Food Grade Manufacturers

Anmol Chemicals is a manufacturer supplier exporter of Gum Tragacanth 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.

Synonyms: Gum Tragacanth or Tragacanth Gum
CAS Number: 9000-65-1, EINECS EC Number: 232-552-5, FEMA: ----,

Gum tragacanth is a viscous, odorless, tasteless, water-soluble mixture of polysaccharides obtained from sap that is drained from the root of the plant and dried. It is used in pharmaceuticals and foods as an emulsifier, thickener, stabilizer, and texturant additive (E number E413).

DEFINITION
Tragacanth is the dried gummy exudation from Astragalus gummifer Labill, or other Asiatic species of Astragalus (Fam. Leguminosae).

IDENTIFICATION
A. Add 1 g to 50 mL of water: it swells and forms a smooth, nearly uniform, stiff, opalescent mucilage free from cellular fragments.

Lead: NMT 10 ppm
Microbial Enumeration Tests and Tests for Specified Microorganisms: It meets the requirements for absence of Salmonella species and Escherichia coli.
Botanic Characteristics:
Tragacanth: It is flattened, lamellated, frequently curved fragments or straight or spirally twisted linear pieces from 0.5 to 2.5 mm in thickness. It is white to weak yellow in color, translucent, and horny in texture. Its fracture is short. It is rendered more easily pulverizable by heating to 50C. It is odorless.
Histology: Pieces of Tragacanth softened in water and mounted in water or glycerin show numerous lamellae and a few starch grains.
Powdered tragacanth: It is white to yellowish white. When examined in water mounts, it shows numerous angular fragments of mucilage with circular or irregular lamellae, and occasional starch grains up to 25 µm in diameter, mostly simple, spherical to elliptical, with occasional two- to four-compound grains, a few of the grains being swollen and more or less altered. The powder shows few or no fragments of lignified vegetable tissue (Indian gum).
Karaya Gum:
Sample solution: 1 g in 20 mL of water
Analysis: Boil the Sample solution until a mucilage is formed, add 5 mL of hydrochloric acid, and again boil the mixture for 5 min.
Acceptance criteria: No pink or red color develops.
Packaging and Storage: Preserve in well-closed containers.

When Powdered Tragacanth is prescribed or demanded, material complying with the requirements below except for Identification test A shall be dispensed or supplied.

DEFINITION
Air-hardened, gummy exudate, flowing naturally or obtained by incision from the trunk and branches of Astragalus gummifer Labill. and certain other species of Astragalus from western Asia.

IDENTIFICATION
A. Tragacanth occurs in thin, flattened, ribbon-like, white or pale yellow, translucent strips, about 30 mm long and 10 mm wide and up to 1 mm thick, more or less curved, horny, with a short fracture; the surface is marked by fine longitudinal striae and concentric transverse ridges. It may also contain pieces similar in shape but somewhat thicker, opaquer and more difficult to fracture.
B. Microscopic examination. The powder is white or almost white and forms a mucilaginous gel with about 10 times its mass of water. Examine under a microscope using a 50 per cent V/V solution of glycerol. The powder shows in the gummy mass numerous stratified cellular membranes that turn slowly violet when treated with iodinated zinc chloride solution. The gummy mass includes starch grains, isolated or in small groups, usually rounded in shape and sometimes deformed, with diameters varying between 4 µm and 10 micro-m, occasionally up to 20 µm, and a central hilum visible between crossed nicol prisms.
C. Examine the chromatograms obtained in the test for acacia.
Results The chromatogram obtained with the test solution shows 3 zones due to galactose, arabinose and xylose. A faint yellowish zone at the solvent front and a greyish-green zone between the zones due to galactose and arabinose may be present.
D. Moisten 0.5 g of the powdered herbal drug with 1 mL of ethanol (96 per cent) and add gradually, while shaking, 50 mL of water until a homogeneous mucilage is obtained. To 5 mL of the mucilage add 5 mL of water and 2 mL of barium hydroxide solution. A slight flocculent precipitate is formed. Heat on a water-bath for 10 min. An intense yellow colour develops.

TESTS
Acacia: To pass the test by Thin-layer chromatography.
Methylcellulose: Examine the chromatograms obtained in the test for acacia.
Results The chromatogram obtained with the test solution does not show a red zone near the solvent front.
Sterculia gum:
A. Place 0.2 g of the powdered herbal drug in a 10 mL ground-glass-stoppered cylinder graduated in 0.1 mL. Add 10 mL of ethanol (60 per cent V/V) and shake. Any gel formed occupies not more than 1.5 mL.
B. To 1.0 g of the powdered herbal drug add 100 mL of water and shake. Add 0.1 mL of methyl red solution. Not more than 5.0 mL of 0.01 M sodium hydroxide is required to change the colour of the indicator.
Foreign matter: Maximum 1.0 per cent.
Place 2.0 g of the powdered herbal drug in a 250 mL round-bottomed flask and add 95 mL of methanol. Swirl to moisten the powder and add 60 mL of hydrochloric acid. Add a few glass beads about 4 mm in diameter and heat on a water-bath under a reflux condenser for 3 h, shaking occasionally. Remove the glass beads and filter the hot suspension in vacuo through a sintered-glass filter (160). Rinse the flask with a small quantity of water and pass the rinsings through the filter. Wash the residue on the filter with about 40 mL of methanol and dry to constant mass at 110C (about 1 h). Allow to cool in a desiccator and weigh. The residue weighs a maximum of 20 mg.
Flow time: Minimum 10 s, or minimum 50 s if the substance to be examined is to be used for the preparation of emulsions.
Place 1.0 g of the powdered herbal drug (125-250) in a 1000 mL round-bottomed flask with a ground-glass stopper, add 8.0 mL of ethanol (96 per cent) and close the flask. Disperse the suspension over the inner surface of the flask by shaking, taking care not to wet the stopper. Open the flask and add as a single portion 72.0 mL of water. Stopper the flask and shake vigorously for 3 min. Allow to stand for 24 h and shake vigorously again for 3 min. Eliminate air bubbles by applying vacuum above the mucilage for 5 min. Transfer the mucilage to a 50 mL cylinder. Dip in the mucilage a piece of glass tubing 200 mm long and 6.0 mm in internal diameter and graduated at 20 mm and 120 mm from the lower end; the tubing must not be rinsed with surface-active substances. When the mucilage has reached the upper mark, close the tube with a finger. Withdraw the closed tube, remove the finger and measure with a stopwatch the time needed for the meniscus to reach the lower graduation. Carry out this operation 4 times and determine the average value of the last 3 determinations.
Total ash: Maximum 4.0 per cent.
Microbial contamination:
TAMC: acceptance criterion 10000 CFU/g.
TYMC: acceptance criterion 100 CFU/g.
Absence of Escherichia coli.
Absence of Salmonella.

Specifications of Tragacanth FCC Food Grade:
Gum Tragacanth; Tragacanth Gum
INS: 413 CAS 9000-65-1

DESCRIPTION
Tragacanth is a dried, gummy exudation obtained from the stems and branches of Astragalus gummifer Labillardiere, or other Asiatic species of Astragalus (Fam. Leguminosae). It consists mainly of high-molecular-weight polysaccharides (arabinogalactans and acidic polysaccharides) that, on hydrolysis, yield galacturonic acid, galactose, arabinose, xylose, and fucose; small amounts of rhammnose and of glucose (derived from traces of starch and/or cellulose) may also be present. Unground Tragacanth occurs as flattened, lamellated, frequently curved fragments or straight or spirally twisted linear pieces from 0.5 to 2.5 mm in thickness. It is white to weak yellow (although some pieces may have a red tinge) and translucent, with a horny texture and a short fracture. It is easier to pulverize if heated to 50C. Powdered Tragacanth is white to yellow-white or pink brown.
Function: Stabilizer; thickener; emulsifier.

REQUIREMENTS
Identification:
A. Microscopic examination of an unground sample in water mounts reveals numerous angular fragments with circular or irregular lamellae, and starch grains up to 25 _m in diameter. There should be very few or no fragments of lignified vegetable tissue.
B. Add iodinated zinc chloride solution to a representative sample. Cellular membranes turn violet.
C. One gram of sample in 50 mL of water swells to form a smooth, stiff, opalescent mucilage free from cellular fragments. The same amount of sample does not swell in 60% (w/v) aqueous ethanol.
Ash (Total): Not more than 3.0%.
Ash (Acid-Insoluble): Not more than 0.5%.
Karaya Gum: Passes test.
Lead: Not more than 2 mg/kg.
Viscosity of a 1% Solution: Not less than 250 centipoises.

Keywords: Gum Tragacanth IP BP Ph Eur EP USP Analytical Reagent FCC Food Grade CAS Number 9000-65-1 Manufacturer Supplier Exporter Monograph Uses Chemical Molecular Formula Weight.

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