Printed on: Fri Jan 05 2024, 09:25:16 PM(EST) Status: Currently Official on 06-Jan-2024 DocId: GUID-D88A5BC1-B3E2-4BF7-828B-B80D9E11E014_6_en-US

Printed by: USP NF Official Date: Official as of 01-Jun-2023 Document Type: USP @2024 USPC
Do Not Distribute DOI Ref: xgb1z DOI: https://doi.org/10.31003/USPNF_M47040_06_01
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Relative standard deviation: NMT 1.0%, Standard

Magnesium Sulfate solution
MgSO4 · xH2O Analysis
Samples: Standard solution and Sample solution
Sulfuric acid magnesium salt (1:1), hydrate;
Calculate the percentage of magnesium sulfate (MgSO4) in
Magnesium sulfate (1:1) monohydrate 138.36
CAS RN®: 14168-73-1; UNII: E2L2TK027P. the portion of the ignited Magnesium Sulfate taken:
Magnesium sulfate (1:1) heptahydrate 246.47 Result = (rU/rS) × (CS/CU) × 100
CAS RN®: 10034-99-8; UNII: SK47B8698T.
Anhydrous 120.37 rU = peak response of magnesium from the Sample
CAS RN®: 7487-88-9; UNII: ML30MJ2U7I. solution
DEFINITION rS = peak response of magnesium from the Standard
Magnesium Sulfate, rendered anhydrous by ignition, contains solution
NLT 98.0% and NMT 102.0% of magnesium sulfate CS = concentration of USP Magnesium Sulfate RS in
(MgSO4). the Standard solution (µg/mL)
CU = concentration of Magnesium Sulfate in the
IDENTIFICATION Sample solution (µg/mL)
• A. IDENTIFICATION TESTS—GENERAL á191ñ, Chemical
Identification Tests, Sulfate Acceptance criteria: 98.0%–102.0% on the anhydrous by
Sample solution: 50 mg/mL ignition basis
Acceptance criteria: Meets the requirements
• B. The retention time of the magnesium peak of the IMPURITIES
Sample solution corresponds to that of the Standard • CHLORIDE AND SULFATE á221ñ, Chloride

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solution, as obtained in the Assay. Sample: 1.0 g
Acceptance criteria: The Sample shows no more chloride
ASSAY than corresponds to 0.20 mL of 0.020 N hydrochloric acid
• PROCEDURE (0.014%).
Use water with a resistivity of NLT 18 megohm-cm to prepare ci
the solutions. Change to read:
Mobile phase: 48 mM methanesulfonic acid. [NOTE—It is
recommended to use suitable cation trapping techniques • ▲IRON á241ñ, Procedures, Procedure 1▲ (CN 1-Jun-2023)
to ensure the Mobile phase is free of all cationic impurities.] Magnesium Sulfate intended for use in preparing
Diluent: 0.02 N hydrochloric acid nonparenteral dosage forms
Standard stock solution: 5 mg/mL of USP Magnesium Sample solution: Dissolve 0.50 g in 40 mL of water.
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Sulfate RS prepared as follows. Transfer an appropriate Analysis: Proceed as directed in the chapter.
portion of USP Magnesium Sulfate RS to a suitable Acceptance criteria: NMT 20 µg/g
volumetric flask. Add about 10% of the final volume of 6 N Magnesium Sulfate intended for use in preparing
hydrochloric acid, and dissolve. Dilute with water to parenteral dosage forms
volume. [NOTE—Rinse all glassware used in this test with Dilute
[NOTE—The Standard stock solution may be used to hydrochloric acid.]
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prepare the System suitability solution.] Dilute hydrochloric acid: 1 mL of hydrochloric acid
Standard solution: 100 µg/mL of USP Magnesium Sulfate diluted with water to 1000 mL
RS in water from the Standard stock solution Solution A: 500 mg/mL of ammonium acetate in water
System suitability solution: 100 µg/mL of USP Magnesium Solution B: 13.4 mg/mL of ascorbic acid in water. Use this
Sulfate RS and 5 µg/mL of USP Calcium Carbonate RS in solution on the day prepared.
Diluent Color reagent: 3.8 mg/mL of 3-(2-pyridyl)-
Sample stock solution: Prepare 5 mg/mL of Magnesium 5,6-di-(2-furyl)-1,2,4-triazine-5′,5′′-disulfonic acid,
Sulfate from the previously ignited Magnesium Sulfate as disodium salt in Solution A. Shake by mechanical means,
directed in the Standard stock solution. if necessary. Use this solution on the day prepared.
Sample solution: 100 µg/mL of Magnesium Sulfate in water Standard stock solution: 1.0 µg/mL of iron, from
from the Sample stock solution Standard Iron Solution in Dilute hydrochloric acid
Chromatographic system Standard solutions: To 3 separate 50-mL volumetric flasks
(See Chromatography á621ñ, System Suitability.) transfer 2.0, 5.0, and 10.0 mL of Standard stock solution,
Mode: LC and dilute each with Dilute hydrochloric acid to 35 mL.
Detector: Conductivity with suppression These solutions contain 2.0, 5.0, and 10.0 µg of iron,
Columns respectively.
Guard: 5-mm × 5-cm; 5.5-µm packing L84 Sample solution: Transfer 10.0 g of Magnesium Sulfate
Analytical: 5-mm × 25-cm; 5.5-µm packing L84 to a 50-mL volumetric flask, add Dilute hydrochloric acid to
Column temperature: 40° 35 mL, and sonicate, if necessary, to dissolve.
Flow rate: 1.0 mL/min Blank: Transfer 35 mL of Dilute hydrochloric acid to a 50-mL
Injection volume: 10 µL volumetric flask.
Run time: NLT 2 times the retention time of magnesium Instrumental conditions
System suitability (See Ultraviolet-Visible Spectroscopy á857ñ.)
Samples: Standard solution and System suitability solution Mode: UV-Vis
[NOTE—The relative retention times for the magnesium Analytical wavelength: 594 nm
and calcium ions are 1.0 and 1.3, respectively.] Analysis
Suitability requirements Samples: Standard solutions, Sample solution, and Blank
Resolution: NLT 3.0 between the magnesium and To each of the flasks containing the Standard solutions,
calcium ions, System suitability solution Sample solution, and the Blank add 5 mL of Solution B
Tailing factor: NMT 2.0, Standard solution and 5 mL of Color reagent. Dilute each solution with

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Printed on: Fri Jan 05 2024, 09:25:16 PM(EST) Status: Currently Official on 06-Jan-2024 DocId: GUID-D88A5BC1-B3E2-4BF7-828B-B80D9E11E014_6_en-US
Printed by: USP NF Official Date: Official as of 01-Jun-2023 Document Type: USP @2024 USPC
Do Not Distribute DOI Ref: xgb1z DOI: https://doi.org/10.31003/USPNF_M47040_06_01
2

Dilute hydrochloric acid to volume, mix, and allow to • LOSS ON DRYING á731ñ
stand for 10 min. Analysis: Dry at 105° for 2 h.
Plot the absorbance values of the Standard solutions versus Acceptance criteria: NMT 2% for the anhydrous form
their iron contents, in µg, and draw the straight line best • LOSS ON IGNITION á733ñ
fitting the 3 plotted points. From the graph, determine Sample: 1 g
the iron content, C, in µg, of the Sample solution. Analysis: Weigh the Sample in a crucible, heat at 105° for
Calculate the content, in µg/g, of iron in the portion of 2 h, then ignite in a muffle furnace at 450 ± 25° to constant
Magnesium Sulfate taken: weight.
Acceptance criteria
Result = C/W Monohydrate: 13.0%–16.0%
Dried form: 22.0%–28.0%
C = content of iron in the Sample solution (µg) Heptahydrate: 40.0%–52.0%
W = weight of Magnesium Sulfate in the Sample
solution (g) ADDITIONAL REQUIREMENTS
• PACKAGING AND STORAGE: Preserve in tight containers.
Acceptance criteria: NMT 0.5 µg/g • LABELING: The label states whether it is the monohydrate,
the dried form, or the heptahydrate. Magnesium Sulfate
Change to read: intended for use in preparing parenteral dosage forms is so
labeled. Magnesium Sulfate not intended for use in
• ▲SELENIUM á291ñ, Procedures, Procedure 1▲ (CN 1-Jun-2023) preparing parenteral dosage forms is so labeled. In
Test solution: 200 mg in 50 mL of 0.25 N nitric acid addition, it may be labeled also as intended for use in
Acceptance criteria: NMT 30 µg/g preparing nonparenteral dosage forms.
• USP REFERENCE STANDARDS á11ñ

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SPECIFIC TESTS USP Calcium Carbonate RS
• PH á791ñ USP Magnesium Sulfate RS
Sample solution: 50 mg/mL
Acceptance criteria: 5.0–9.2
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