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Printed by: Le Tran Official Date: Official as of 01-Jan-2018 Document Type: NF @2021 USPC
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Sample to one of the beakers and the Control to the other
beaker at the point of maximum agitation. Stir until the solution (mg/mL)
mixtures dissolve, and then continue stirring for 30 min CU = concentration of the Sample solution (mg/mL)
longer. Do not allow the temperature of the mixtures to
drop below 60° during the stirring. Discontinue stirring, Acceptance criteria: NMT 0.075%
and allow the mixtures to cool at room temperature for • PYRUVIC ACID
NLT 2 h.
Acceptance criteria: A firm, rubbery gel forms with the
Sample after the temperature drops below 40°, but no such
ci Solution A: 5 mg/mL of 2,4-dinitrophenylhydrazine in 2 N
hydrochloric acid
Standard stock solution: 90 µg/mL of pyruvic acid
gel forms with the Control. Standard solution: Transfer 10.0 mL of the Standard stock
solution to a glass-stoppered, 50-mL flask. Add 20.0 mL of
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ASSAY 1 N hydrochloric acid, weigh the flask, and reflux for 3 h,
• PROCEDURE taking precautions to prevent loss of vapors. Cool, and add
Sample: 1.2 g water to make up for any weight loss during refluxing.
Analysis: Proceed as directed in Alginates Assay á311ñ. Transfer 2.0 mL of this solution to a 30-mL separator
Acceptance criteria: 4.2%–5.0% of carbon dioxide on the containing 1.0 mL of Solution A. Mix, and allow to stand for
dried basis, corresponding to 91.0%–108.0% of 5 min. Extract the mixture with 5 mL of ethyl acetate, and
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Xanthan Gum discard the aqueous layer. Extract the hydrazone from the
IMPURITIES ethyl acetate with three 5-mL portions of sodium carbonate
• ARSENIC, Method II á211ñ: NMT 3 µg/g TS, collect the extracts in a 50-mL volumetric flask, and
• LEAD á251ñ dilute with sodium carbonate TS to volume.
Sample: Prepare a Test Preparation as directed in the chapter Sample stock solution: 6 mg/mL of Xanthan Gum
Control: Use 5 mL of Diluted Standard Lead Solution (5 µg Sample solution: Transfer 10.0 mL of the Sample stock
of Pb). solution to a glass-stoppered, 50-mL flask. Proceed as
Analysis: Proceed as directed in the chapter. directed in the Standard solution, beginning with “Add
Acceptance criteria: NMT 5 µg/g 20.0 mL of 1 N hydrochloric acid…”.
• LIMIT OF ISOPROPYL ALCOHOL Blank: Sodium carbonate TS
Internal standard solution: 1 mg/mL of tertiary butyl Instrumental conditions
alcohol (See Ultraviolet-Visible Spectroscopy á857ñ.)
Standard stock solution: 1 mg/mL of isopropyl alcohol Mode: Spectrophotometry
Standard solution: Pipet 4 mL of the Standard stock Analytical wavelength: 375 nm
solution and 4 mL of the Internal standard solution into a Cell: 1 cm
100-mL volumetric flask, and dilute with water to volume. Analysis
Sample solution: Disperse 1 mL of a suitable antifoam Samples: Standard solution, Sample solution, and Blank
emulsion in 200 mL of water contained in a 1000-mL, Acceptance criteria: The absorbance of the Sample solution
round-bottom distilling flask having a 24/40 standard taper is NLT that of the Standard solution, corresponding to NLT
ground joint. Add 5 g of Xanthan Gum, and shake for 1 h 1.5% of pyruvic acid.
on a wrist-action mechanical shaker. Connect the flask to a SPECIFIC TESTS
fractionating column, and distill 100 mL, adjusting the heat • MICROBIAL ENUMERATION TESTS á61ñ and TESTS FOR
so that foam does not enter the column. Add by pipet 4 mL SPECIFIED MICROORGANISMS á62ñ: It meets the
of the Internal standard solution. requirements of the tests for Salmonella species and
Chromatographic system Escherichia coli.
(See Chromatography á621ñ, System Suitability.) • LOSS ON DRYING á731ñ
Mode: GC Analysis: Dry at 105° for 2.5 h.
Detector: Flame ionization Acceptance criteria: NMT 15.0%
• ASH
Sample: Weigh 3 g in a tared crucible.
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Printed on: Wed Aug 04 2021, 06:29:41 PM Official Status: Currently Official on 04-Aug-2021 DocId: 1_GUID-19CE56D5-FD93-4814-A4E4-8A232ED922F6_3_en-US
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Printed by: Le Tran Official Date: Official as of 01-Jan-2018 Document Type: NF @2021 USPC
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Analysis: Incinerate the Sample at 650° until free from rinsing the walls of the beaker. Approximately 10 min after
carbon. Cool the crucible and its contents in a desiccator, the addition of the Sample to the water, remove the beaker
and weigh. from the propeller-type stirrer, and vigorously stir the
Acceptance criteria: The weight of the ash is between solution by hand to ensure that all the particles around the
6.5%–16.0%, calculated on the dried basis. edge of the beaker are in solution. Return the beaker to the
• VISCOSITY—ROTATIONAL METHODS á912ñ stirrer, and agitate at 800 rpm for a total mixing time of 2 h.
Sample: Prepare a dry blend of 3.0 g of Xanthan Gum and Adjust the temperature to 24 ± 1°, and stir by hand in a
3.0 g of potassium chloride. vertical motion to eliminate any thixotropic effects or
Instrumental conditions layering. Each hand mixing should be NMT 15–30 s, and
Instrument: Rotational viscometer the last hand mixing should occur immediately before
Spindle cylinder dimensions measuring the viscosity. With the spindle rotating at
Diameter: 1.27 cm 60 rpm, immediately observe and record the scale reading.
Height: 0.16 cm Convert the scale readings to centipoises by multiplying the
Shaft diameter: 0.32 cm readings by the constant for the viscometer spindle and
Distance from top of cylinder to lower lip of shaft: speed used.
2.54 cm Acceptance criteria: NLT 600 centipoises at 24°
Immersion depth: 5.00 cm (No. 3 spindle)
Spindle rotation speed: 60 rpm ADDITIONAL REQUIREMENTS
Analysis: To a 400-mL beaker add 250 mL of water. Add the • PACKAGING AND STORAGE: Preserve in well-closed
Sample slowly while stirring at 800 rpm, using a containers.
low-pitched, propeller-type stirrer. Add 44 mL of water,
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