Alginic Acid
(al jin' ik as' id).
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(C6H8O6)n
Alginic acid     [9005-32-7].
DEFINITION
Alginic Acid is a hydrophilic colloidal carbohydrate extracted with dilute alkali from various species of brown seaweeds (Phaeophyceae).
IDENTIFICATION
•  A.
Analysis:  To 5 mL of a 1-in-150 solution in 0.1 N sodium hydroxide add 1 mL of calcium chloride TS.
Acceptance criteria:  A voluminous, gelatinous precipitate is formed.
•  B.
Analysis:  To 5 mL of a 1-in-150 solution in 0.1 N sodium hydroxide add 1 mL of 4 N sulfuric acid.
Acceptance criteria:  A heavy, gelatinous precipitate is formed.
•  C.
Analysis:  To 5 mg in a test tube add 5 mL of water, 1 mL of a freshly prepared 1-in-100 solution of 1,3-naphthalenediol in alcohol, and 5 mL of hydrochloric acid. Heat the mixture to boiling, boil gently for 3 min, then cool to 15. Transfer the contents of the test tube to a 30-mL separator with the aid of 5 mL of water, and extract with 15 mL of isopropyl ether.
Acceptance criteria:  The isopropyl ether extract exhibits a deeper purplish hue than that from a blank, similarly prepared.
IMPURITIES
•  Arsenic, Method II 211: NMT 3 ppm
•  Lead 251
Standard solution:  5 mL of Diluted Standard Lead Solution
Test preparation:  Add 1.0 g to 20 mL of nitric acid in a 250-mL conical flask, mix, and heat carefully until the Alginic Acid is dissolved. Continue heating until the volume is reduced to 7 mL. Cool rapidly to room temperature, transfer to a 100-mL volumetric flask, and dilute with water to volume.
Analysis:  Use 50.0 mL of the Test preparation, and proceed as directed in the chapter, using 15 mL of ammonium citrate solution, 3 mL of potassium cyanide solution, and 0.5 mL of hydroxylamine hydrochloride solution. After the first dithizone extraction, wash the combined chloroform layers with 5 mL of water, discarding the water layer and continuing in the usual manner by extracting with 20 mL of 0.2 N nitric acid.
Acceptance criteria:  NMT 5 µg of lead (corresponding to NMT 10 ppm)
•  Heavy Metals, Method II 231
Analysis:  Use a platinum crucible for the ignition, and use nitric acid in place of sulfuric acid to wet the test specimen.
Acceptance criteria:  NMT 40 ppm
SPECIFIC TESTS
•  Microbial Enumeration Tests 61 and Tests for Specified Microorganisms 62: The total aerobic microbial count does not exceed 2 × 102 cfu/g, and the tests for Salmonella species and Escherichia coli are negative.
•  pH 791: 1.5–3.5, in a 3-in-100 dispersion in water
•  Loss on Drying 731: Dry a sample at 105 for 4 h: it loses NMT 15.0% of its weight.
•  Articles of Botanical Origin, Total Ash 561
Sample:  4 g of Alginic Acid
Analysis:  Proceed as directed in the chapter, carefully igniting the Sample in a tared platinum dish, until the residue is thoroughly carbonized (5 min). Then ignite in a muffle furnace at a temperature of 800 ± 25 until the carbon is completely burned off (20–35 min).
Acceptance criteria:  NMT 4.0% of ash
•  Fats and Fixed Oils, Acid Value 401
Sample:  1 g of Alginic Acid
Analysis:  Suspend the Sample in a mixture of 50 mL of water and 30.0 mL of calcium acetate solution (11 in 250). Shake thoroughly, allow the mixture to stand for 1 h, and add phenolphthalein TS. Titrate the liberated acetic acid with 0.1 N sodium hydroxide VS. Perform a blank determination, and calculate the Acid Value:
Result = [(VS VB) × N × F]/W
VS== volume of 0.1 N sodium hydroxide VS consumed in the titration of the Sample (mL)
VB== volume of 0.1 N sodium hydroxide VS consumed in the titration of the blank (mL)
N== normality of sodium hydroxide VS (mEq/mL)
F== equivalency factor of potassium hydroxide, 56.11 (mg/mEq)
W== weight of Alginic Acid taken (g)
Acceptance criteria:  NLT 230 on the dried basis
ADDITIONAL REQUIREMENTS
•  Packaging and Storage: Preserve in well-closed containers.
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(EXC2010) Monographs - Excipients
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(GCM2010) General Chapters - Microbiology
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(GCM2010) General Chapters - Microbiology
USP35–NF30 Page 1690