Acacia
(a kay' sha).
DEFINITION
Acacia is the dried gummy exudate from the stems and branches of Acacia senegal (L.) Willd. or of other related African species of Acacia (Fam. Leguminosae).
IDENTIFICATION
•  A.
Analysis:  To 10 mL of a cold solution (1 in 50) add 0.2 mL of diluted lead subacetate TS.
Acceptance criteria:  A flocculent, or curdy, white precipitate is formed immediately.
IMPURITIES
•  Arsenic, Method II 211: NMT 3 ppm
•  Lead 251: NMT 10 ppm
•  Heavy Metals, Method II 231: NMT 40 ppm
SPECIFIC TESTS
•  Botanic Characteristics
Acacia:  Spheroidal tears up to 32 mm in diameter or in angular fragments of white to yellowish white color. It is translucent or somewhat opaque from the presence of numerous minute fissures; very brittle, the fractured surface glassy and occasionally iridescent. It is almost odorless and produces a mucilaginous sensation on the tongue.
Flake Acacia:  White to yellowish white, thin flakes, appearing under the microscope as colorless, striated fragments
Powdered Acacia:  White to yellowish white, angular microscopic fragments with only traces of starch or vegetable tissues present
Granular Acacia:  White to pale yellowish white, fine granules. Under the microscope it appears as colorless, glassy, irregularly angular fragments up to 100 µm in thickness, some of which exhibit parallel linear streaks.
Spray-dried Acacia:  White to off-white compacted microscopic fragments or whole spheres
•  Microbial Enumeration Tests 61 and Tests for Specified Microorganisms 62: Meets the requirements of the tests for absence of Salmonella species
•  Water Determination, Method III (Gravimetric) 921
Analysis:  For unground Acacia, crush in a mortar until it passes through a No. 40 sieve, and mix the ground material before weighing the test specimen. Dry a sample at 105 for 5 h.
Acceptance criteria:  NMT 15.0% of its weight
•  Insoluble Residue
Sample solution:  Dissolve 5.0 g of powdered or finely ground Acacia in 100 mL of water. Add 10 mL of 3 N hydrochloric acid.
Analysis:  Boil the Sample solution gently for 15 min. Pass by suction, while hot, through a tared filtering crucible. Wash thoroughly with hot water, dry at 105 for 1 h, and weigh.
Acceptance criteria:  The weight of the residue thus obtained does not exceed 50 mg.
•  Starch or Dextrin
Sample solution:  A solution (1 in 50)
Analysis:  Boil the Sample solution cool, and add iodine TS.
Acceptance criteria:  No bluish or reddish color is produced.
•  Solubility and Reaction
Sample:  1 g
Analysis:  Dissolve the Sample in 2 mL of water.
Acceptance criteria:  The resulting solution flows readily and is acid to litmus.
•  Tannin-Bearing Gums
Sample solution:  A solution (1 in 50)
Analysis:  To 10 mL of the Sample solution add 0.1 mL of ferric chloride TS.
Acceptance criteria:  No blackish coloration or blackish precipitate is produced.
ADDITIONAL REQUIREMENTS
•  Packaging and Storage: Preserve in tight containers.
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1-301-816-8335
(EXC2010) Monographs - Excipients
61 Radhakrishna S Tirumalai, Ph.D.
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(GCM2010) General Chapters - Microbiology
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(GCM2010) General Chapters - Microbiology
USP35–NF30 Page 1679