Printed on: Fri Jan 06 2023, 01:33:21 AM(EST) Status: Currently Official on 06-Jan-2023 DocId: GUID-580C591A-B6AA-4FC0-97E5-5339E134700F_3_en-US

Printed by: Wisang Seta Geni Official Date: Official as of 01-May-2018 Document Type: USP & NF @2023 USPC
Do Not Distribute DOI Ref: fgz6d DOI: https://doi.org/10.31003/USPNF_M76040_03_01
1

Instrumental conditions
Sodium Chloride (See Fluorescence Spectroscopy á853ñ.)
Portions of this monograph that are national USP text, and are Mode: Fluorescence
not part of the harmonized text, are marked with symbols Excitation wavelength: 392 nm
(◆ ◆) to specify this fact. Emission wavelength: 518 nm
Analysis
NaCl 58.44 Samples: Sample solution, Standard solution, and Blank
Sodium Chloride CAS RN®: 7647-14-5. solution. Use the Blank solution to set the instrument
to zero.
DEFINITION
Determine the fluorescence intensities of the Sample
Sodium Chloride contains NLT 99.0% and NMT 100.5% of
solution and Standard solution.
sodium chloride (NaCl), calculated on the dried basis.
Acceptance criteria: The fluorescence of the Sample
IDENTIFICATION solution does not exceed that of the Standard solution
• A. IDENTIFICATION TESTS—GENERAL á191ñ, Sodium: Meets (0.2 ppm).
the requirements • ◆ ARSENIC á211ñ, Method I: NMT 1 ppm◆
• B. CHLORIDE • BARIUM
Sample solution: 3 mg of Sodium Chloride in 2 mL of water Analysis: To 5 mL of the solution prepared for the test for
Analysis: Acidify the Sample solution with diluted nitric acid, Appearance of Solution add 2 mL of 2 N sulfuric acid and
and add 0.4 mL of silver nitrate TS. Shake, and allow to 5 mL of water, as test solution. To another 5 mL of the
stand. A curdled, white precipitate is formed. Centrifuge, solution prepared for the test for Appearance of Solution add
wash the precipitate with three 1-mL portions of water, and 7 mL of water, as reference solution. Let stand for 2 h.
discard the washings. Carry out this operation rapidly in Acceptance criteria: Any opalescence in the test solution is

al
subdued light, disregarding the fact that the supernatant not more intense than that in the reference solution.
may not become perfectly clear. Suspend the precipitate in • FERROCYANIDES
2 mL of water, and add 1.5 mL of 10 N ammonium Sample solution: Dissolve 2.0 g in 6 mL of water.
hydroxide. Analysis: To the Sample solution add 0.5 mL of a mixture of
Acceptance criteria: The precipitate dissolves easily with 5 mL of ferric ammonium sulfate solution (10 mg/mL in
the possible exception of a few large particles, which 2.5 g/L (0.05 N) of sulfuric acid) and 95 mL of ferrous sulfate
dissolve more slowly.
ASSAY
ci solution (10 mg/mL in water).
Acceptance criteria: No blue color develops in 10 min.
• IODIDES
• PROCEDURE Sample: 5 g of Sodium Chloride
Sample: 50 mg of Sodium Chloride Analysis: Moisten the Sample by the dropwise addition of a
ffi
Analysis: Dissolve the Sample in 50 mL of water, and titrate freshly prepared mixture of 0.15 mL of sodium nitrite
with 0.1 N silver nitrate VS (see Titrimetry á541ñ), solution (100 mg/mL), 2 mL of 1 N sulfuric acid, 25 mL of
determining the endpoint potentiometrically. Each mL of iodide-free starch TS, and 25 mL of water. After 5 min,
0.1 N silver nitrate is equivalent to 5.844 mg of sodium examine the substance in natural light.
chloride (NaCl). Acceptance criteria: No blue color is observed.
Acceptance criteria: 99.0%–100.5% on the dried basis • IRON
O

IMPURITIES Sample solution: Use a 10-mL portion of the solution

• ALUMINUM (where it is labeled as intended for use in the prepared for the test for Appearance of Solution.
manufacture of peritoneal dialysis solutions, hemodialysis Standard solution: Immediately before use, dilute Standard
solutions, or hemofiltration solutions) Iron Solution (see Iron á241ñ) 1 to 10 with water. This
Buffer: Dissolve 50 g of ammonium acetate in 150 mL of solution contains the equivalent of 1 µg/mL of iron.
water, adjust with glacial acetic acid to a pH of 6.0, and Combine 4 mL of this solution and 6 mL of water.
dilute with water to 250 mL. Analysis: To each of the solutions add 2 mL of a
Aluminum standard solution: To 352 mg of aluminum 200-mg/mL solution of citric acid and 0.1 mL of
potassium sulfate in a 100-mL volumetric flask add a few thioglycolic acid. Mix, make alkaline with stronger
mL of water, and swirl to dissolve. Add 20 mL of diluted ammonia water, and dilute with water to 20 mL.
sulfuric acid, dilute with water to volume, and mix. Acceptance criteria: After 5 min, any pink color in the
Immediately before use, transfer 1.0 mL of this solution to a Sample solution is not more intense than that from the
100-mL volumetric flask, and dilute with water to volume. Standard solution (NMT 2 ppm).
Sample solution: Dissolve 20.0 g of Sodium Chloride in • LIMIT OF BROMIDES
100 mL of water, and add 10 mL of Buffer. Extract this [NOTE—Prepare the Sample solution and the Standard
solution with successive portions of 20, 20, and 10 mL of a solution concomitantly.]
0.5% solution of 8-hydroxyquinoline in chloroform, Standard solution: To 5.0 mL of a solution containing 3 µg/
combining the chloroform extracts in a 50-mL volumetric mL of potassium bromide add 2.0 mL of pH 4.7 phenol
flask. Dilute the combined extracts with chloroform to red TS and 1.0 mL of chloramine T solution (0.1 mg/mL),
volume. and mix immediately. After 2 min, add 0.15 mL of 0.1 N
Standard solution: Prepare a mixture of 2.0 mL of sodium thiosulfate, mix, and dilute with water to 10.0 mL.
Aluminum standard solution, 10.0 mL of Buffer, and 98 mL Sample solution: To 0.5 mL of the solution prepared for the
of water. Extract this mixture as described for the Sample test for Appearance of Solution add 4.0 mL of water, 2.0 mL
solution, and dilute the combined extracts with chloroform of pH 4.7 phenol red TS, and 1.0 mL of chloramine T
to volume. solution (0.1 mg/mL), and mix immediately. After 2 min,
Blank solution: Prepare a mixture of 10 mL of Buffer and add 0.15 mL of 0.1 N sodium thiosulfate, mix, and dilute
100 mL of water. Extract this mixture as described for with water to 10.0 mL.
Sample solution, and dilute the combined extracts with Instrumental conditions
chloroform to volume. (See Ultraviolet-Visible Spectroscopy á857ñ.)
Mode: UV-Vis

https://online.uspnf.com/uspnf/document/1_GUID-580C591A-B6AA-4FC0-97E5-5339E134700F_3_en-US 1/3
Printed on: Fri Jan 06 2023, 01:33:21 AM(EST) Status: Currently Official on 06-Jan-2023 DocId: GUID-580C591A-B6AA-4FC0-97E5-5339E134700F_3_en-US
Printed by: Wisang Seta Geni Official Date: Official as of 01-May-2018 Document Type: USP & NF @2023 USPC
Do Not Distribute DOI Ref: fgz6d DOI: https://doi.org/10.31003/USPNF_M76040_03_01
2

Analytical wavelength: 590 nm 10.0 g of Sodium Chloride dissolved in 100 mL of water. If

Comparison liquid: Water the color changes to violet, titrate the solution with 0.01 M
Analysis edetate disodium VS to a deep blue endpoint.
Samples: Standard solution and Sample solution Acceptance criteria: The volume of 0.01 M edetate
Acceptance criteria: The absorbance of the Sample solution disodium consumed in the second titration does not exceed
is not greater than that of the Standard solution (NMT 2.5 mL (NMT 100 ppm, calculated as Ca).
100 ppm). • NITRITES
• LIMIT OF PHOSPHATES Sample solution: To 10 mL of the solution prepared in the
Sulfomolybdic acid solution: Dissolve with heating 2.5 g of test for Appearance of Solution add 10 mL of water.
ammonium molybdate in 20 mL of water. Dilute 28 mL of Instrumental conditions
sulfuric acid in 50 mL of water, then cool. Mix the two (See Ultraviolet-Visible Spectroscopy á857ñ.)
solutions, and dilute with water to 100 mL. Mode: UV-Vis
Phosphate standard stock solution: 0.716 mg/mL of Analytical wavelength: 354 nm
monobasic potassium phosphate in water Cell: 1 cm
Phosphate standard solution: 7.16 µg/mL from Phosphate Analysis
standard stock solution in water. [NOTE—Prepare this Sample: Sample solution
solution fresh.] Acceptance criteria: Absorbance is NMT 0.01.
Standard solution: Dilute 2 mL of the Phosphate standard • SULFATE
solution with water to 100 mL. [NOTE—All solutions used for this test must be prepared
Sample solution: Dilute 2 mL of the solution prepared in with distilled water.]
the test for Appearance of Solution with water to 100 mL. Sulfate standard solution A: To 181 mg of potassium
Analysis: To the Standard solution and the Sample solution sulfate in a 100-mL volumetric flask add a few mL of 30%

al
add 4 mL of Sulfomolybdic acid solution, and add 0.1 mL of a alcohol. Swirl to dissolve, dilute with 30% alcohol to
mixture of 1 mL of stronger acid stannous chloride TS and volume, and mix. Immediately before use, transfer 10.0 mL
10 mL of 2 N hydrochloric acid. After 10 min, compare the of this solution to a 1000-mL volumetric flask, and dilute
colors of 20 mL of each solution. with 30% alcohol to volume (10 µg/mL of sulfate).
Acceptance criteria: Any color in the Sample solution is not Sulfate standard solution B: To 181 mg of potassium
more intense than that in the Standard solution (NMT sulfate in a 100-mL volumetric flask add a few mL of water.
25 ppm).
• LIMIT OF POTASSIUM (where it is labeled as intended for use
in the manufacture of injectable dosage forms, peritoneal
ci Swirl to dissolve, dilute with water to volume, and mix.
Immediately before use, transfer 10.0 mL of this solution
to a 1000-mL volumetric flask, and dilute with water to
dialysis solutions, hemodialysis solutions, or hemofiltration volume (10 µg/mL of sulfate).
solutions) Sodium chloride solution: 50 mg/mL of Sodium Chloride
ffi
[NOTE—The Standard solution and the Sample solution in water
may be modified, if necessary, to obtain solutions of Barium chloride solution: 250 mg/mL of barium chloride
suitable concentrations adaptable to the linear or in water
working range of the instrument.] Standard solution: To 1.5 mL of Sulfate standard solution A
Standard solutions: Dissolve 1.144 g of potassium chloride, add 1 mL of Barium chloride solution. Shake, and allow to
previously dried at 105° for 3 h, in water. Dilute with water stand for 1 min. To 2.5 mL of the resulting suspension add
O

to 1000 mL, and mix. This solution contains the equivalent 15 mL of Sulfate standard solution B and 0.5 mL of 5 N
of 600 µg/mL of potassium. Dilute as required to obtain acetic acid, and mix.
NLT 3 solutions at concentrations that span the expected Sample solution: To 1.5 mL of Sulfate standard solution A
value in the Sample solution. add 1 mL of Barium chloride solution. Shake, and allow to
Sample solution: Transfer 1.00 g of Sodium Chloride to a stand for 1 min. To 2.5 mL of the resulting suspension add
100-mL volumetric flask. Add water and swirl to dissolve, 15 mL of Sodium chloride solution and 0.5 mL of 5 N acetic
dilute with water to volume, and mix. acid, and mix.
Instrumental conditions Acceptance criteria: Any opalescence produced in the
(See Atomic Absorption Spectroscopy á852ñ.) Sample solution after 5 min standing is NMT that produced
Mode: Atomic emission spectroscopy in the Standard solution (200 ppm).
Analytical wavelength: 766.5 nm
Flame: Air–acetylene SPECIFIC TESTS
Analysis • ◆APPEARANCE OF SOLUTION: Dissolve 20.0 g of Sodium
Samples: Standard solutions and Sample solution Chloride in carbon dioxide-free water, and dilute with the
Measure, at least three times, the emission intensity of the same solvent to 100.0 mL. This solution is clear and
Sample solution and the Standard solutions. Prepare a colorless.◆
calibration curve from the mean of the readings • ACIDITY OR ALKALINITY
obtained with the Standard solutions, and determine the Analysis: To 20 mL of the solution prepared for the test for
concentration of potassium in the Sample solution. Appearance of Solution add 0.1 mL of bromothymol blue TS.
Acceptance criteria: NMT 500 ppm Acceptance criteria: NMT 0.5 mL of 0.01 N
• MAGNESIUM AND ALKALINE-EARTH METALS hydrochloric acid or 0.01 N sodium hydroxide is required
Buffer: Prepare pH 10.0 ammonia–ammonium chloride to change the color of this solution.
buffer by dissolving 5.4 g of ammonium chloride in 20 mL • LOSS ON DRYING á731ñ
of water, adding 20 mL of ammonium hydroxide, and Sample: 1.000 g
diluting with water to 100 mL. Analysis: Dry the Sample in an oven at 105° for 2 h.
Analysis: To 200 mL of water add 0.1 g of hydroxylamine Acceptance criteria: NMT 0.5%
hydrochloride, 10 mL of Buffer, 1 mL of 0.1 M zinc sulfate, • ◆ BACTERIAL ENDOTOXINS TEST á85ñ: The level of bacterial
and 0.15 g of eriochrome black T trituration. Heat to 40°. endotoxins is such that the requirement under the relevant
Titrate this solution with 0.01 M edetate disodium VS until dosage form monograph(s) in which Sodium Chloride is
the violet color changes to deep blue. To this solution add used can be met. Where the label states that Sodium
Chloride must be subjected to further processing during

https://online.uspnf.com/uspnf/document/1_GUID-580C591A-B6AA-4FC0-97E5-5339E134700F_3_en-US 2/3
Printed on: Fri Jan 06 2023, 01:33:21 AM(EST) Status: Currently Official on 06-Jan-2023 DocId: GUID-580C591A-B6AA-4FC0-97E5-5339E134700F_3_en-US
Printed by: Wisang Seta Geni Official Date: Official as of 01-May-2018 Document Type: USP & NF @2023 USPC
Do Not Distribute DOI Ref: fgz6d DOI: https://doi.org/10.31003/USPNF_M76040_03_01
3

the preparation of injectable dosage forms, the level of • ◆LABELING: Where Sodium Chloride is intended for use in
bacterial endotoxins is such that the requirement under the the manufacture of injectable dosage forms, peritoneal
relevant dosage form monograph(s) in which Sodium dialysis solutions, hemodialysis solutions, or hemofiltration
Chloride is used can be met.◆ solutions, it is so labeled. Where Sodium Chloride must be
• ◆ STERILITY TESTS á71ñ: Where the label states that Sodium subjected to further processing during the preparation of
Chloride is sterile, it meets the requirements for Sterility injectable dosage forms to ensure acceptable levels of
under the relevant dosage form monograph(s) in which bacterial endotoxins, it is so labeled. Where Sodium
Sodium Chloride is used.◆ Chloride is sterile, it is so labeled.◆
ADDITIONAL REQUIREMENTS
• ◆PACKAGING AND STORAGE: Preserve in well-closed
containers.◆

al
ci
ffi
O

https://online.uspnf.com/uspnf/document/1_GUID-580C591A-B6AA-4FC0-97E5-5339E134700F_3_en-US 3/3