Salicylamide

This article is compiled based on the United States Pharmacopeia (USP) – 2025 Edition

Issued and maintained by the United States Pharmacopeial Convention (USP)

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1 DEFINITION

Salicylamide contains NLT 98.0% and NMT 102.0% of salicylamide (C₇H₇NO₂), calculated on the anhydrous basis.

2 IDENTIFICATION

Change to read:

A. Spectroscopic Identification Tests 〈197〉, Infrared Spectroscopy: 197K (CN 1-May-2020)

B. The retention time of the major peak of the Sample solution corresponds to that of the Standard solution, as obtained in Assay.

3 ASSAY

3.1 Procedure

Solution A: 0.1% Formic acid in water

Solution B: Acetonitrile

Mobile phase: See Table 1.

Table 1

Diluent: Acetonitrile and water (50:50)

System suitability solution: 1.0 mg/mL of USP Salicylamide RS and 0.001 mg/mL of USP Salicylic Acid Related Compound B RS in Diluent

Standard solution: 0.2 mg/mL of USP Salicylamide RS in Diluent

Sample solution: 0.2 mg/mL of Salicylamide in Diluent. Pass through a suitable filter of 0.2-µm pore size.

Chromatographic system

(See Chromatography 〈621〉, System Suitability.)

Mode: LC

Detector: UV 300 nm

Column: 2.1-mm × 10-cm; 1.8-µm packing L1

Column temperature: 35°

Flow rate: 0.3 mL/min

Injection volume: 1 µL

System suitability

Samples: System suitability solution and Standard solution

Suitability requirements

Resolution: NLT 1.5 between salicylic acid related compound B and salicylamide, System suitability solution

Relative standard deviation: NMT 0.73%, Standard solution

Analysis

Samples: Standard solution and Sample solution

Calculate the percentage of salicylamide (C₇H₇NO₂) in the portion of Salicylamide taken:

Result = (r_U/r_S) × (C_S/C_U) × 100

r_U = peak response from the Sample solution

r_S = peak response from the Standard solution

C_S = concentration of USP Salicylamide RS in the Standard solution (mg/mL)

C_U = concentration of Salicylamide in the Sample solution (mg/mL)

Acceptance criteria: 98.0%–102.0% on the anhydrous basis

4 IMPURITIES

4.1 Residue on Ignition 〈281〉: NMT 0.1%

4.2 Organic Impurities

Solution A, Solution B, Mobile phase, Diluent, System suitability solution, and Chromatographic system: Proceed as directed in the Assay.

Standard solution: 0.001 mg/mL each of USP Salicylamide RS and USP Salicylic Acid RS in Diluent

Sample solution: 1.0 mg/mL of Salicylamide in Diluent. Pass through a suitable filter of 0.2-µm pore size.

System suitability

Samples: System suitability solution and Standard solution

Suitability requirements

Resolution: NLT 1.5 between salicylic acid related compound B and salicylamide, System suitability solution

Relative standard deviation: NMT 2.8%, Standard solution

Analysis

Samples: Standard solution and Sample solution

Calculate the percentage of salicylic acid in the portion of Salicylamide taken:

Result = (r_U/r_S) × (C_S/C_U) × 100

r_U = peak response of the salicylic acid peak from the Sample solution

r_S = peak response of the salicylic acid peak from the Standard solution

C_S = concentration of USP Salicylic Acid RS in the Standard solution (mg/mL)

C_U = concentration of Salicylamide in the Sample solution (mg/mL)

Calculate the percentage of each unspecified impurity in the portion of Salicylamide taken:

Result = (r_U/r_S) × (C_S/C_U) × 100

r_U = peak response of each unspecified impurity from the Sample solution

r_S = peak response of salicylamide from the Standard solution

C_S = concentration of USP Salicylamide RS in the Standard solution (mg/mL)

C_U = concentration of Salicylamide in the Sample solution (mg/mL)

Acceptance criteria: See Table 2. Disregard any impurity peak less than 0.05%.

Table 2

ᵃ For identification only.

5 SPECIFIC TESTS

Water Determination, Method I 〈921〉: NMT 0.5%

6 ADDITIONAL REQUIREMENTS

Packaging and Storage: Preserve in well-closed containers.

USP Reference Standards 〈11〉

USP Salicylamide RS

USP Salicylic Acid RS

USP Salicylic Acid Related Compound B RS

4-Hydroxyisophthalic acid

C₈H₆O₅ 182.13