Propantheline Bromide Tablets
If you find any inaccurate information, please let us know by providing your feedback here
This article is compiled based on the United States Pharmacopeia (USP) – 2025 Edition
Issued and maintained by the United States Pharmacopeial Convention (USP)
1 DEFINITION
Propantheline Bromide Tablets contain NLT 90.0% and NMT 110.0% of the labeled amount of propantheline bromide (C₂₃H₃₀BrNO₃).
2 IDENTIFICATION
A.
Standard solution: 6 mg/mL of USP Propantheline Bromide RS in chloroform
Sample solution: Triturate the equivalent to 90 mg of propantheline bromide, from finely powdered Tablets, with 10 mL of chloroform. Filter, and wash the filter with 10 mL of chloroform, collecting the filtrate and washing in a separator. Add 10 mL of water, shake, and discard the chloroform layer. Wash the aqueous layer with two 10-mL portions of ether, and discard the ether washings. Filter the aqueous solution, and evaporate on a steam bath with the aid of a current of dry air to dryness. Dissolve the residue in 5 mL of chloroform.
Analysis: In a well-ventilated hood, apply 2 mL each of the Standard solution and Sample solution dropwise to separate salt plates while continuously evaporating the solvent with the aid of an IR heat lamp and a current of dry air. Heat the residues at 105° for 15 min.
Acceptance criteria: The IR absorption spectrum of the residue on the single salt plate exhibits maxima only at the same wavelengths as those of a similar preparation of USP Propantheline Bromide RS, treated in the same manner.
B. The retention time of the major peak of the Sample solution corresponds to that of the Standard solution, as obtained in the Assay.
3 ASSAY
Procedure
Buffer: 17.3 g of sodium dodecyl sulfate in 1000 mL of water containing 10 mL of phosphoric acid in a 2000-mL volumetric flask. Add 250 mL of 0.5 M sodium hydroxide, and while stirring, adjust with 0.5 M sodium hydroxide or dilute phosphoric acid (1 in 10) to a pH of 3.5 ± 0.05. Dilute with water to volume.
Mobile phase: Acetonitrile and Buffer (55:45)
Standard solution: 0.3 mg/mL of USP Propantheline Bromide RS in Mobile phase
Sample solution: Weigh and finely powder NLT 20 Tablets. Transfer a portion of the powder equivalent to 15 mg of propantheline bromide to a 50-mL volumetric flask, and dissolve in Mobile phase. Dilute with Mobile phase to volume, and filter.
Chromatographic system
(See Chromatography 〈621〉, System Suitability.)
Mode: LC
Detector: UV 254 nm
Column: 4.6-mm × 25-cm; packing L7
Flow rate: 2.0 mL/min
Injection volume: 50 µL
System suitability
Sample: Standard solution
Suitability requirements
Relative standard deviation: NMT 2.0%
Analysis
Samples: Standard solution and Sample solution
Calculate the percentage of the labeled amount of propantheline bromide (C₂₃H₃₀BrNO₃) in the portion of Tablets 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 Propantheline Bromide RS in the Standard solution (mg/mL)
Cᵤ = nominal concentration of propantheline bromide in the Sample solution (mg/mL)
Acceptance criteria: 90.0%–110.0%
4 PERFORMANCE TESTS
Dissolution, Procedure for a Pooled Sample 〈711〉
Medium: pH 4.5 ± 0.05 acetate buffer prepared by mixing 1.64 g of anhydrous sodium acetate and 1.25 mL of glacial acetic acid with 500 mL of water, and diluting with water to obtain 1000 mL of solution having a pH of 4.50 ± 0.05; 500 mL
Apparatus 2: 50 rpm
Time: 45 min
Standard solution: USP Propantheline Bromide RS at a known concentration in Medium
Sample solution: Filtered portion of solution under test
Buffer, Mobile phase, Chromatographic system, and System suitability: Prepare as directed in the Assay.
Analysis: Determine the amount of propantheline bromide (C₂₃H₃₀BrNO₃) dissolved by proceeding as directed in the Assay.
Tolerances: NLT 75% (Q) of the labeled amount of propantheline bromide (C₂₃H₃₀BrNO₃) is dissolved.
Uniformity of Dosage Units 〈905〉: Meet the requirements
5 IMPURITIES
Organic Impurities
Buffer: 17.3 g of sodium dodecyl sulfate in 1000 mL of water containing 10 mL of phosphoric acid in a 2000-mL volumetric flask. Add 250 mL of 0.5 M sodium hydroxide, and while stirring, adjust with 0.5 M sodium hydroxide or dilute phosphoric acid (1 in 10) to a pH of 3.5 ± 0.05. Dilute with water to volume.
Mobile phase: Acetonitrile and Buffer (55:45)
Standard solution:
12.0 µg/mL of USP Propantheline Bromide Related Compound A RS,
3.0 µg/mL of USP Xanthanoic Acid RS, and
3.0 µg/mL of USP Xanthone RS in Mobile phase
Sample solution: Prepare as directed in the Assay.
Chromatographic system
(See Chromatography 〈621〉, System Suitability.)
Mode: LC
Detector: UV 254 nm
Column: 4.6-mm × 25-cm; packing L7
Flow rate: 2.0 mL/min
Injection volume: 50 µL
System suitability
Sample: Standard solution
Suitability requirements
Resolution: NLT 1.2 between the least resolved peaks
Relative standard deviation: NMT 6.0% for each component
Analysis
Samples: Standard solution and Sample solution
Calculate the percentage of xanthanoic acid, xanthone, and propantheline bromide related compound A in the portion of Tablets taken:
Result = (rᵤ / rₛ) × (Cₛ / Cᵤ) × 100
rᵤ = peak response for xanthanoic acid, xanthone, or propantheline bromide related compound A from the Sample solution
rₛ = peak response for xanthanoic acid, xanthone, or propantheline bromide related compound A from the Standard solution
Cₛ = concentration of xanthanoic acid, xanthone, or propantheline bromide related compound A in the Standard solution (µg/mL)
Cᵤ = nominal concentration of propantheline bromide in the Sample solution (µg/mL)
Acceptance criteria:
NMT 4.0% of propantheline bromide related compound A;
NMT 1.0% each of xanthone and xanthanoic acid.
Disregard any peak less than 0.1%.
6 ADDITIONAL REQUIREMENTS
Packaging and Storage: Preserve in well-closed containers.
USP Reference Standards 〈11〉
USP Propantheline Bromide RS
USP Propantheline Bromide Related Compound A RS
9-Hydroxypropantheline bromide.
C₂₃H₃₀BrNO₄ 464.39
USP Xanthanoic Acid RS C₁₃H₆O₄ 226.23
USP Xanthone RS C₁₃H₈O₂ 196.21
