Clomipramine Hydrochloride Compounded Oral Suspension, Veterinary
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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
Clomipramine Hydrochloride Compounded Oral Suspension, Veterinary contains NLT 90.0% and NMT 110.0% of the labeled amount of clomipramine hydrochloride (C19H23ClN2 · HCl). Prepare Clomipramine Hydrochloride Compounded Oral Suspension, Veterinary 1 mg/mL as follows (see Pharmaceutical Compounding-Nonsterile Preparations 〈795〉):
Clomipramine Hydrochloride tabletsa equivalent to | 100 mg of clomipramine hydrochloride |
Vehicle: a 1:1 mixture of Ora-Plusb and Ora-Sweet SFb, a sucient quantity to make | 100 mL |
a Clomicalm 20-mg tablets, Novartis Animal Health, Greensboro, NC.
b Perrigo, Allegan, MI.
Place the Clomipramine Hydrochloride tablets in a suitable container and comminute to a fine powder. Wet the powder with a small amount of Vehicle and triturate to make a smooth paste. Add the Vehicle to make the mortar contents pourable. Transfer contents stepwise and quantitatively to a calibrated container using the remainder of the Vehicle. Add sufficient Vehicle to bring to final volume. Shake to mix well.
2 ASSAY
2.1 Procedure
Solution A: Methanol and acetonitrile (50:50)
Solution B: 25 mM monobasic potassium phosphate adjusted with phosphoric acid to a pH of 3.2
Mobile phase: See Table 1.
Table 1 | ||
Time (min) | Solution A (%) | Solution B (%) |
| 0 | 40 | 60 |
| 4 | 50 | 50 |
| 10 | 50 | 50 |
| 10.5 | 40 | 60 |
| 20 | 40 | 60 |
Standard solution: 0.1 mg/mL of clomipramine hydrochloride prepared from USP Clomipramine Hydrochloride RS and methanol. Vortex for about 30 s until dissolved.
Sample solution: Transfer 1.0 mL of Oral Suspension, Veterinary to a 10-mL volumetric flask, and rinse the pipette with about 2 mL of methanol. Vortex for 30 s and dilute with methanol to volume.
Chromatographic system
- (See Chromatography <621>, System Suitability.)
- Mode: LC
- Detector: UV 254 nm
- Column: 2.0-mm × 10-cm; 2.5-µm packing L1
- Column temperature: 50°
- Flow rate: 0.275 mL/min
- Injection volume: 5 µL
System suitability
- Sample: Standard solution
- [Note-The retention time for clomipramine hydrochloride is about 8.4 min.]
- Suitability requirements
- Tailing factor: NMT 2.0
- Relative standard deviation: NMT 2.0% for replicate injections
Analysis
Samples: Standard solution and Sample solution
Calculate the percentage of the labeled amount of clomipramine hydrochloride (C19H23ClN2 · HCl) in the portion of Oral Suspension, Veterinary taken:
Result = (ru/rs) × (Cs/Cu) × 100
ru = peak response of clomipramine hydrochloride from the Sample solution
rs = peak response of clomipramine hydrochloride from the Standard solution
Cs = concentration of USP Clomipramine Hydrochloride RS in the Standard solution (mg/mL)
Cu = nominal concentration of clomipramine hydrochloride in the Sample solution (mg/mL)
Acceptance criteria: 90.0%-110.0%
3 SPECIFIC TESTS
pH 〈791〉: 3.8–4.8
4 ADDITIONAL REQUIREMENTS
Packaging and Storage: Package in tight, light-resistant containers. Store in a refrigerator or at controlled room temperature.
Beyond-Use Date: NMT 90 days after the day on which it was compounded when stored in a refrigerator or at controlled room temperature
Labeling: Label it to indicate that it is to be well shaken before use, and to state the Beyond-Use Date. Label it to state that it is for veterinary use.
USP Reference Standards 〈11〉
USP Clomipramine Hydrochloride RS
