Trospium Chloride Tablets

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

Trospium Chloride Tablets contain NLT 90.0% and NMT 110.0% of the labeled amount of trospium chloride (C₂₅H₃₀CINO₃).

2 IDENTIFICATION

A. The retention time and UV spectrum of the major peak of the Sample solution correspond to those of the major peak of the Standard solution, as obtained in the Assay.

3 ASSAY

PROCEDURE

Mobile phase: Acetonitrile, triethylamine, phosphoric acid, and water (350:1:3:650)

Standard solution: 0.1 mg/mL of USP Trospium Chloride RS in Mobile phase

Sample solution: Weigh and finely powder NLT 20 Tablets. Transfer a portion of the powder, equivalent to 100 mg of trospium chloride, to a 100-mL volumetric flask. Add 75 ml of Mobile phase, and sonicate for about 30 min. Dilute with Mobile phase to volume. Further dilute with Mobile phase to obtain a solution having a nominal concentration of 0.1 mg/mL of trospium chloride. Pass through a suitable filter of 0.45-um pore size, and use the filtrate.

Chromatographic system

(See Chromatography (621), System Suitability.)

Mode: LC

Detector: UV 215 nm

Column: 4.6-mm x 25-cm; 5-µm packing 11

Flow rate: 1.0 mL/min

Column temperature: 40^o

Injection volume: 20 µL

System suitability

Sample: Standard solution

Suitability requirements

Tailing factor: NMT 2.0

Relative standard deviation: NMT 2.0%

Analysis

Samples: Standard solution and Sample solution

Calculate the percentage of the labeled amount of trospium chloride (C₂₅H₃₀CINO₃) in the portion of Tablets taken:

Result = (r_u /r_s ) × (C_s /C_u ) × 100

r_u = peak response of trospium chloride from the Sample solution

r_s = peak response of trospium chloride from the Standard solution

C_s = concentration of USP Trospium Chloride RS in the Standard solution (mg/mL)

C_u = nominal concentration of trospium chloride in the Sample solution (mg/mL)

Acceptance criteria: 90.0%–110.0%

4 PERFORMANCE TESTS

Change to read:

DISSOLUTION (711)

Test 1

Medium: 0.1 N hydrochloric acid: 1000 mL

Apparatus 2: 50 rpm

Time: 30 min

Mobile phase: Acetonitrile, triethylamine, phosphoric acid, and water (350:13:650)

Standard stock solution: 0.5 mg/mL of USP Trospium Chloride RS in Mobile phase

Standard solution: 0.02 mg/mL in Medium from the Standard stock solution.

Sample solution: Pass a portion of the solution under test through a suitable filter of 0.45-µm pore size.

Chromatographic system

(See Chromatography (621), System Suitability.)

Mode: LC

Detector: UV 215 nm

Column: 4.6-mm x 25-cm; 5-µm packing L1

Flow rate: 1.0 mL/min

Column temperature: 40^o

Injection volume: 50 µL

System suitability

Sample: Standard solution

Suitability requirements

Tailing factor: NMT 2.0

Relative standard deviation: NMT 2.0%

Analysis

Samples: Standard solution and Sample solution

Calculate the percentage of the labeled amount of trospium chloride (C₂₅H₃₀CINO₃) dissolved:

Result = (r_u /r_s ) × (C_s /L) × V × 100

r_u = peak response from the Sample solution

r_s = peak response from the Standard solution

C_s = concentration of the Standard solution (mg/mL)

L = label claim (mg/Tablet)

V = volume of Medium, 1000 mL

Tolerances: NLT 80% (Q) of the labeled amount of trospium chloride is dissolved.

Test 2: If the product complies with this test, the labeling indicates that it meets USP Dissolution Test 2.

Medium: 0.1 N hydrochloric acid; 1000 mL

Apparatus 2: 50 rpm

Time: 30 min

Mobile phase: Acetonitrile, triethylamine, phosphoric acid, and water (300:1:3:700)

Standard stock solution: 0.2 mg/mL of USP Trospium Chloride RS in Medium

Standard solution: 0.02 mg/mL in Medium from the Standard stock solution

Sample solution: Pass a portion of the solution under test through a suitable lter of 0.45-µm pore size.

Chromatographic system

(See Chromatography 〈621〉, System Suitability.)

Mode: LC

Detector: UV 215 nm

Columns

Guard: 4.0-mm × 4-cm; 5-µm packing L7

Analytical: 4.0-mm × 12.5-cm; 4-µm packing L7

Flow rate: 1.0 mL/min

Column temperature: 40°

Injection volume: 10 µL

System suitability

Sample: Standard solution

Suitability requirements

Tailing factor: NMT 2.0

Relative standard deviation: NMT 2.0%

Analysis

Samples: Standard solution and Sample solution

Calculate the percentage of the labeled amount of trospium chloride (C₂₅H₃₀CINO₃) dissolved:

Result = (r_u /r_s ) × (C_s /L)× V × 100

r_u = peak response from the Sample solution

r_s = peak response from the Standard solution

C_s = concentration of the Standard solution (mg/mL)

L = label claim (mg/Tablet)

V = volume of Medium, 1000 mL

Tolerances: NLT 75% (Q) of the labeled amount of trospium chloride is dissolved.

Test 3: If the product complies with this test, the labeling indicates that it meets USP Dissolution Test 3.

Medium: 0.1 N hydrochloric acid: 500 mL

Apparatus 2: 50 rpm

Time: 30 min

Mobile phase: Acetonitrile, triethylamine, phosphoric acid, and water (35: 0.1:0.3:65)

Standard stock solution: 0.5 mg/mL of USP Trospium Chloride RS in Medium, Sonicate to dissolve, if necessary.

Standard solution: 0.04 mg/ml. of USP Trospium Chloride RS from the Standard stock solution in Medium

Sample solution: Pass the portion of the solution under test through a suitable filter of 0.45-µm pore size, discarding an appropriate volume of filtrate so that a consistent result can be obtained.

Chromatographic system

(See Chromatography (621), System Suitability.)

Mode: LC

Detector: UV 215 nm.

Column: 4.6-mm x 25-cm; 5-µm packing L1

Column temperature: 40°

Flow rate: 1.0 mL/min

Injection volume: 50 µL

Run time: NLT 1.8 times the

System suitability

Sample: Standard solution

Suitability requirements

Tailing factor: NMT 2.0

Relative standard deviation: NMT 2.0%

Analysis

Samples: Standard solution and Sample solution

Calculate the percentage of the labeled amount of trospium chloride (C₂₅H₃₀CINO₃) dissolved:

Result = (r_u /r_s ) × C_s × (1/L) × V × 100

r_u = peak response of trospium from the Sample solution

r_s = peak response of trospium from the Standard solution

C_ss = concentration of USP Trospium Chloride RS in the Standard solution (mg/mL)

L = label claim (mg/Tablet)

V = volume of Medium, 500 mL

Tolerances: NLT 80% (Q) of the labeled amount of trospium chloride is dissolved. _{(RB 1-Jan-2025)}

Uniformity of Dosage Units 〈905〉: Meet the requirements

5 IMPURITIES

ORGANIC IMPURITIES

Mobile phase: Acetonitrile, triethylamine, phosphoric acid, and water (300:1:3:700)

System suitability solution: 0.01 mg/mL of USP Trospium Chloride RS. 0.003 mg/mL of USP Trospium Chloride Related Compound A RS, and 0.015 mg/mL of USP Trospium Chloride Related Compound B RS in Mobile phase

Standard solution: 0.003 mg/ml of USP Trospium Chloride RS in Mobile phase

Sample solution: Finely powder NLT 20 Tablets. Transfer a portion of the powder, equivalent to 150 mg of trospium chloride, to a 50-mL volumetric flask. Add 30 mL of Mobile phase, and sonicate for about 30 min. Dilute with Mobile phase to volume. Pass through a suitable filter of 0.45-µm pore size, and use the filtrate.

Chromatographic system

(See Chromatography (621), System Suitability.)

Mode: LC

Detector: UV 215 nm

Column: 4.6-mm x 25-cm; 5-µm packing L7

Flow rate: 1.0 mL/min

Column temperature: 40°

Injection volume: 20 µL

System suitability

Samples: System suitability solution and Standard solution

Suitability requirements

Resolution: NLT 3 between trospium chloride related compound B and trospium, System suitability solution

Relative standard deviation: NMT 5%, Standard solution

Analysis

Samples: Standard solution and Sample solution

Calculate the percentage of any impurity in the portion of Tablets taken:

Result = (r_u /r_s ) × (C_s /C_u ) × (1/F) × 100

r_u = peak response of each individual impurity from the Sample solution

r_s = peak response of trospium chloride from the Standard solution

C_s = concentration of USP Trospium Chloride RS in the Standard solution (mg/mL)

C_u = nominal concentration of trospium chloride in the Sample solution (mg/mL)

F = relative response factor (see Table 1)

Acceptance criteria: See Table 1.

Table 1

6 ADDITIONAL REQUIREMENTS

Packaging and Storage: Preserve in tight containers, protected from light. Store at controlled room temperature.

Labeling: When more than one Dissolution test is given, the labeling states the Dissolution test used only if Test 1 is not used.

USP Reference Standards 〈11〉

USP Trospium Chloride RS

USP Trospium Chloride Related Compound A RS

Benzilic acid.

C₁₄H₁₂O₃          228.24 CAS RN: 76-93-7.

USP Trospium Chloride Related Compound B RS

Nortropane benzilate; (1R,3r,5S)-8-azabicyclo [3.2.1]octan-3-yl hydroxydiphenylacetate.

C₂₁H₂₃NO₃       337.41