Tragacanth
(traj' a kanth).
DEFINITION
Tragacanth is the dried gummy exudation from Astragalus gummifer Labillardière, 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.
IMPURITIES
•  Lead 251: NMT 10 ppm
•  Heavy Metals, Method II 231: NMT 20 ppm
SPECIFIC TESTS
•  Microbial Enumeration Tests 61 and Tests for Specified Microorganisms 62: 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 50. 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.
ADDITIONAL REQUIREMENTS
•  Packaging and Storage: Preserve in well-closed containers.
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Topic/Question Contact Expert Committee
Monograph Robert H. Lafaver, M.S.
Scientific Liaison
1-301-816-8335
(EXC2010) Monographs - Excipients
61 Radhakrishna S Tirumalai, Ph.D.
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1-301-816-8339
(GCM2010) General Chapters - Microbiology
62 Radhakrishna S Tirumalai, Ph.D.
Principal Scientific Liaison
1-301-816-8339
(GCM2010) General Chapters - Microbiology
USP35–NF30 Page 2006