Sodium Salicylate CAS 54-21-7 USP35 Standard

Sodium Salicylate
C7H5NaO3 160.10
Benzoic acid, 2-hydroxy-, monosodium salt;
Monosodium salicylate [54-21-7]; UNII: WIQ1H85SYP.
DEFINITION
Sodium Salicylate contains NLT 98.0% and NMT 102.0% of sodium salicylate (C7H5NaO3), calculated on the anhydrous basis.
IDENTIFICATION
Change to read:
• A. SPECTROSCOPIC IDENTIFICATION TESTS <197>, Infrared Spectroscopy: 197K (CN 1-MAY-2020)
• B. IDENTIFICATION TESTS-GENERAL, Sodium <191>
Sample solution: 50 mg/mL of Sodium Salicylate in water
Analysis: Proceed as directed for Sodium in the chapter.
Acceptance criteria: Meets the requirements
• C. The retention time of the major peak of the Sample solution corresponds to that of the Standard solution, as obtained in the Assay.
ASSAY
• PROCEDURE
Mobile phase: Methanol, trifluoroacetic acid, and water (40:0.1:60)
Standard solution: 0.04 mg/mL of USP Sodium Salicylate RS in Mobile phase
Sample solution: 0.04 mg/mL of Sodium Salicylate in Mobile phase
Chromatographic system
(See Chromatography <621>, System Suitability.)
Mode: LC
Detector: UV 212 nm
Column: 2.1-mm × 5-cm; 1.7-µm packing L1
Column temperature: 30°
Flow rate: 0.2 mL/min
Injection volume: 2 µL
System suitability
Sample: Standard solution
Suitability requirements
Tailing factor: 0.8-1.8
Relative standard deviation: NMT 0.73%
Analysis
Samples: Standard solution and Sample solution
Calculate the percentage of sodium salicylate (C7H5NaO3) in the portion of Sodium Salicylate taken:
Result = (ru /rs ) × (Cs /Cu ) × 100
ru= peak response from the Sample solution
rs= peak response from the Standard solution
Cs= concentration of USP Sodium Salicylate RS in the Standard solution (mg/mL)
Cu= concentration of Sodium Salicylate in the Sample solution (mg/mL)
Acceptance criteria: 98.0%–102.0% on the anhydrous basis
IMPURITIES
• SULFITE or THIOSULFATE
Sample solution: 1.0 g of Sodium Salicylate in 20 mL of water
Analysis: Add 1 mL of hydrochloric acid to the Sample solution, and filter the liquid.
Acceptance criteria: NMT 0.15 mL of 0.10 N iodine is required to produce a yellow color in the filtrate.
• ORGANIC IMPURITIES
Mobile phase: Methanol, trifluoroacetic acid, and water (40:0.1:60)
Standard stock solution: 0.125 mg/mL of USP Sodium Salicylate RS, 0.25 mg/mL of USP Salicylic Acid Related Compound A RS,
0.125 mg/mL of USP Salicylic Acid Related Compound B RS, and 0.05 mg/mL of USP Phenol RS in Mobile phase
Standard solution: 1.25 µg/mL of USP Sodium Salicylate RS, 2.5 µg/mL of USP Salicylic Acid Related Compound A RS, 1.25 µg/mL of
USP Salicylic Acid Related Compound B RS, and 0.5 µg/mL of USP Phenol RS in Mobile phase from Standard stock solution
Sample solution: 2.5 mg/mL of Sodium Salicylate in Mobile phase
Chromatographic system
(See Chromatography <621>, System Suitability.)
Mode: LC
Detector: UV 212 nm
Column: 2.1-mm × 5-cm; 1.7-µm packing L1
Column temperature: 30°
Flow rate: 0.2 mL/min
Injection volume: 2 µL
System suitability
Sample: Standard solution
Suitability requirements
Resolution: NLT 3.0 between salicylic acid related compound A and phenol; NLT 3.0 between phenol and salicylic acid related compound B
Relative standard deviation: NMT 2% for each peak
Analysis
Samples: Standard solution and Sample solution
Calculate the percentage of salicylic acid related compound A, salicylic acid related compound B, or phenol in the portion of
Sodium Salicylate taken:
Result = (ru /rs ) × (Cs /Cu ) × 100
ru= peak response of salicylic acid related compound A, salicylic acid related compound B, or phenol from the Sample solution
rs= peak response of salicylic acid related compound A, salicylic acid related compound B, or phenol from the Standard solution
Cs= concentration of USP Salicylic Acid Related Compound A RS, USP Salicylic Acid Related Compound B RS, or USP Phenol RS in the Standard solution (mg/mL)
Cu= concentration of Sodium Salicylate in the Sample solution (mg/mL)
Calculate the percentage of any other individual impurity in the portion of Sodium Salicylate taken:
Result = (ru /rs ) × (Cs /Cu ) × 100
ru= peak response of any other individual impurity from the Sample solution
rs= peak response of salicylic acid related compound B from the Standard solution
Cs= concentration of USP Salicylic Acid Related Compound B RS in the Standard solution (mg/mL)
Cu= concentration of Sodium Salicylate in the Sample solution (mg/mL)
Acceptance criteria: See Table 1.
Table 1
Name Relative Retention Time Acceptance Criteria, NMT (%)
Salicylic acid related compound A 0.3 0.1
Phenol 0.4 0.02
Salicylic acid related compound B 0.6 0.05
Salicylic acid 1.0 –
Any other individual impurity – 0.05
Total impurities – 0.2
SPECIFIC TESTS
• WATER DETERMINATION, Method I<921>: NMT 0.5%
ADDITIONAL REQUIREMENTS
• PACKAGING AND STORAGE: Preserve in well-closed, light-resistant containers.
• USP REFERENCE STANDARDS <11>
USP Salicylic Acid Related Compound A RS
4-Hydroxybenzoic acid.
C7H6O3 138.12
USP Salicylic Acid Related Compound B RS
4-Hydroxyisophthalic acid.
C8H6O5 182.13
USP Sodium Salicylate RS

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