Diethylcarbamazine Citrate 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

10 21 3 Diethylcarbamazine Citrate Tablets contain NLT 95.0% and NMT 105.0% of the labeled amount of diethylcarbamazine citrate (C₁₀H₂₁NO₃ · C₆H₈O₇)

[NOTE-Diethylcarbamazine Citrate Tablets labeled solely for veterinary use are exempt from the requirements of the test for Dissolution.]

2 IDENTIFICATION

A. IDENTIFICATION ORGANIC NITROGENOUS BASES (181): Meet the requirements

3 ASSAY

3.1 PROCEDURE

Solution A: 10 g/L of monobasic potassium phosphate in water

Solution B: 31.24 mg/mL of monobasic potassium phosphate in water

Mobile phase: Methanol and Solution A (100:900)

Standard solution: 0.1 mg/mL of USP Diethylcarbamazine Citrate RS in Solution B

Sample solution: Nominally 0.1 mg/mL of diethylcarbamazine citrate prepared as follows. Transfer an amount of finely powdered Tablets (from NLT 20 Tablets) equivalent to 5 mg of diethylcarbamazine citrate to a 50-mL volumetric flask, and dissolve in and dilute with Solution B to volume.

3.1.1 Chromatographic system

Mode: LC

Detector: UV 220 nm

Column: 3.9-mm x 15-cm; 5-µm packing L1

Flow rate: 0.8 mL/min

Injection volume: 20 µL

3.1.2 System suitability

Sample: Standard solution

3.1.3 Suitability requirements

Relative standard deviation: NMT 2.0%

3.1.4 Analysis

Samples: Standard solution and Sample solution

Calculate the percentage of the labeled amount of diethylcarbamazine citrate (C₁₀H₂₁NO₃ · C₆H₈O₇) in the portion of Tablets taken: 

                Result = (r_U/r_S) x (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 Diethylcarbamazine Citrate RS in the Standard solution (mg/mL)

C_U = nominal concentration of diethylcarbamazine citrate in the Sample solution (mg/mL) Cu

Acceptance criteria: 95.0%-105.0%

4 PERFORMANCE TESTS

DISINTEGRATION (701). (for Tablets labeled solely for veterinary use): 30 min

DISSOLUTION (711).

Procedure for a pooled sample

Medium: Water, 900 mL

Apparatus 2: 50 rpm

Time: 45 min

Buffer: 62.48 g/L of monobasic potassium phosphate in water

Sample solutions: Prepare by quantitatively diluting filtered portions of the solution under test with Buffer (1:1)

Analysis: Determine the amount of diethylcarbamazine citrate (C₂H₂N₂O CHO,) dissolved as directed in the Assay.

Tolerances: NLT 75% (Q) of the labeled amount of diethylcarbamazine citrate (C10H2N₂O CH₃O₂) is dissolved. 3

UNIFORMITY OF DOSAGE UNITS (905): Meet the requirements

5 IMPURITIES

5.1 ORGANIC IMPURITIES

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

Citric acid solution: 2 mg/mL of citric acid in Solution B

Standard solution: 0.003 mg/mL of USP Diethylcarbamazine Citrate RS in Solution B

Sample solution: Transfer an amount of finely powdered Tablets (from NLT 20 Tablets) nominally equivalent to 300 mg of diethylcarbamazine citrate to a 100-mL volumetric flask. Dilute with Solution B to volume. Filter or centrifuge, and use the clear filtrate or supernatant.

Analysis

Samples: Citric acid solution, Standard solution, and Sample solution

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

                Result = (r_U/r_S) x (C_S/C_U) × 100

r_U = peak response of any individual impurity from the Sample solution. [NOTE-Disregard any peak having a retention time corresponding to that of the main peak of the Citric acid solution.]

r_S = peak response of diethylcarbamazine citrate from the Standard solution

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

C_U = nominal concentration of diethylcarbamazine citrate in the Sample solution (mg/mL)

Acceptance criteria: NMT 0.1%

6 ADDITIONAL REQUIREMENTS

PACKAGING AND STORAGE: Preserve in tight containers.

USP REFERENCE STANDARDS (11).

USP Diethylcarbamazine Citrate RS