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Printed by: USP NF Official Date: Official as of 01-Dec-2022 Document Type: NF @2024 USPC
Do Not Distribute DOI Ref: 01ond DOI: https://doi.org/10.31003/USPNF_M77180_05_01
1

Sample solution: Dry Sodium Propionate at 105° for 2 h.

Sodium Propionate After the sample cools to room temperature in a desicooler
or an equivalent device, weigh the sample, and prepare a
Change to read: solution of 2.5 mg/mL in Diluent.
▲ Chromatographic system
(See Chromatography á621ñ, System Suitability.)
Mode: LC
Detector: UV 210 nm
Column: 4.6-mm × 25-cm column; 5-µm packing L1
Column temperature: 45°
▲ (NF 1-Dec-2022) Flow rate: 1.0 mL/min
C3H5NaO2 96.06 Injection volume: 20 µL
Propanoic acid, sodium salt▲▲ (NF 1-Dec-2022); Run time: 35 min
Sodium propionate ▲▲ (NF 1-Dec-2022) CAS RN®: 137-40-6. System suitability
Samples: System suitability solution and Standard solution
[NOTE—The approximate relative retention times for
Change to read: related substances are listed in Table 2.]
Suitability requirements
DEFINITION
Resolution: NLT 1.5 between the sodium propionate
Sodium Propionate, dried at 105° for 2 h, contains ▲NLT
peak and the sodium acrylate peak, System suitability
98.0% and NMT 102.0%▲ (NF 1-Dec-2022) of sodium
solution
propionate (C3H5NaO2). Tailing factor: NMT 2, determined from the sodium

al
IDENTIFICATION propionate peak, Standard solution
• A. SPECTROSCOPIC IDENTIFICATION TESTS á197ñ, Infrared Relative standard deviation: NMT 1%, determined
Spectroscopy: 197K from the sodium propionate peak, Standard solution
Analysis: Perform test on an undried sample. Analysis
Acceptance criteria: Meets the requirements Samples: Standard solution and Sample solution
• B. IDENTIFICATION TESTS—GENERAL á191ñ, Chemical Calculate the percentage of Sodium Propionate in the
Identification Tests, Sodium
Sample solution: 1 in 20
Acceptance criteria: Meets the requirements
ci portion of sample taken:

Result = (rU/rS) × (CS/CU) × 100

rU = peak area of sodium propionate from the Sample

Add the following:
ffi
solution
▲
• C. CHROMATOGRAPHIC IDENTITY rS = peak area of sodium propionate from the
Analysis: Examine the chromatograms obtained in the Standard solution
Assay. CS = concentration of USP Sodium Propionate RS in
Acceptance criteria: The retention time of the major peak the Standard solution (mg/mL)
of the Sample solution corresponds to that of the Standard CU = concentration of Sodium Propionate in the
O

solution.▲ (NF 1-Dec-2022) Sample solution (mg/mL)

ASSAY Acceptance criteria: 98.0%–102.0%▲ (NF 1-Dec-2022)

Change to read:
Add the following:
• PROCEDURE
▲
Solution A: 10 mM potassium phosphate, monobasic,
▲
IMPURITIES
with the pH adjusted to 2.5 using phosphoric acid • ORGANIC IMPURITIES
Solution B: Acetonitrile Mobile phase, Diluent, System suitability solution, and
Mobile phase: See Table 1. Chromatographic system: Proceed as directed in the
Assay.
Table 1 Sensitivity solution: 0.01 mg/mL of USP Sodium
Propionate RS in Diluent
Time Solution A Solution B
(min) (%) (%)
Standard solution: 0.02 mg/mL of USP Sodium
Propionate RS in Diluent
0 100 0 Sample solution: 20 mg/mL of Sodium Propionate in
3.0 100 0 Diluent
System suitability
15.0 70 30 Samples: System suitability solution, Sensitivity solution, and
25.0 50 50 Standard solution.
[NOTE—The approximate relative retention times for
26.0 100 0 related substances are listed in Table 2.]
35.0 100 0
Table 2
Diluent: 2% (v/v) phosphoric acid in water Relative
Retention
System suitability solution: 2.5 mg/mL of USP Sodium Name Time
Propionate RS and 0.01 mg/mL of sodium acrylate in
Diluent Sodium acetate 0.5
Standard solution: 2.5 mg/mL of USP Sodium Propionate Sodium acrylate 0.95
RS in Diluent

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Printed on: Fri Jan 05 2024, 09:22:30 PM(EST) Status: Currently Official on 06-Jan-2024 DocId: GUID-E7FACD22-923A-424A-9B3A-AB743AEEFF6D_5_en-US
Printed by: USP NF Official Date: Official as of 01-Dec-2022 Document Type: NF @2024 USPC
Do Not Distribute DOI Ref: 01ond DOI: https://doi.org/10.31003/USPNF_M77180_05_01
2

Table 2 (continued) F = relative response factor (see Table 3)

Relative
Retention Acceptance criteria: See Table 3.
Name Time
Sodium propionate 1.0 Table 3
Relative Acceptance
Response Criteria,
Suitability requirements Name Factor NMT (%)
Resolution: NLT 1.5 between the sodium propionate
peak and the sodium acrylate peak, System suitability Sodium acetate 1.0 0.3
solution Sodium acrylate 95.3 0.1
Relative standard deviation: NMT 5.0%, determined
Sodium propionate — —
from the sodium propionate peak, Standard solution
Signal-to-noise ratio: NLT 10, determined from the Any unidentified indi-
sodium propionate peak, Sensitivity solution vidual impurity 1.0 0.1
Analysis Total impurities — 1.0▲ (NF 1-Dec-2022)
Samples: Standard solution and Sample solution
[NOTE—The peak eluting at RRT 0.3 is sodium ion peak.
This peak and the peaks eluting before it are exclusive SPECIFIC TESTS
from integration. These peaks are not from organic • WATER DETERMINATION á921ñ, Method I: NMT 1.0%
impurities of sodium propionate.] • ALKALINITY
Calculate the percentage of each individual impurity in the Sample solution: 2.0 g of Sodium Propionate in 20 mL of
portion of sample taken: water

al
Analysis: Add phenolphthalein TS to the Sample solution.
Result = (rU/rS) × (CS/CU) × (1/F) × 100 Acceptance criteria: If a pink color is produced, it is
discharged by 0.60 mL of 0.10 N sulfuric acid.
rU = peak area of each individual impurity from the
ADDITIONAL REQUIREMENTS
Sample solution
• PACKAGING AND STORAGE: Preserve in tight containers.
rS

CS
= peak area of sodium propionate from the
Standard solution
= concentration of USP Sodium Propionate RS in
the Standard solution (mg/mL)
ci • USP REFERENCE STANDARDS á11ñ
USP Sodium Propionate RS

CU = concentration of Sodium Propionate in the

Sample solution (mg/mL)
ffi
O

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