Enalapril Maleate Compounded Oral Suspension, Veterinary
DEFINITION
Enalapril Maleate Compounded Oral Suspension, Veterinary contains NLT 90.0% and NMT 110.0% of the labeled content of enalapril maleate (C20H28N2O5·C4H4O4).
Prepare Enalapril Maleate Compounded Oral Suspension, Veterinary 10 mg/mL as follows (see Pharmaceutical Compounding—Nonsterile Preparations 
795
).
795).| Enalapril maleate | 1 g |
| Ora-Blenda, a sufficient quantity to make | 100 mL |
|
a
Perrigo, Minneapolis, MN.
|
|
Pour the Enalapril maleate powder into a suitable container. Wet the powder with a small amount of Ora-Blend, and triturate to make a smooth paste. Add the Ora-Blend to make the mortar contents pourable. Transfer the contents of the mortar stepwise and quantitatively to a calibrated container using the Ora-Blend. Add sufficient Ora-Blend to bring the preparation to final volume. Shake to mix well.
ASSAY
• Procedure
Solution A:
Dissolve 2.8 g of monobasic sodium phosphate in 1000 mL of water. Adjust with 1 N sodium hydroxide to a pH of 6.8.
Solution B:
Acetonitrile and Solution A (5:95)
Solution C:
Acetonitrile and Solution A (66:34)
Solution D:
Dissolve 2.8 g of monobasic sodium phosphate in 1000 mL of water. Adjust with phosphoric acid to a pH of 2.5.
Diluent:
Acetonitrile and Solution D (5:95)
Mobile phase:
See Table 1.
Table 1
| Time (min) |
Solution B (%) |
Solution C (%) |
|---|---|---|
| 0 | 95 | 5 |
| 20 | 40 | 60 |
| 25 | 40 | 60 |
| 26 | 95 | 5 |
| 30 | 95 | 5 |
Standard solution:
1 mg/mL of USP Enalapril Maleate RS in Diluent
Sample solution:
Shake thoroughly each bottle of Oral Suspension. Transfer 1.0 mL of the Oral Suspension into a 10-mL volumetric flask, dilute with Diluent to volume, and mix well to dissolve. Pass through a PVDF filter of 0.45-µm pore size, discarding the first 3 mL to waste.
Chromatographic system
Mode:
LC
Detector:
UV 215 nm
Column:
4.6-mm × 25-cm; 5-µm packing L21
Column temperature:
60
Flow rate:
1.0 mL/min
Injection volume:
10 µL
System suitability
Sample:
Standard solution
[Note—The retention time for enalapril maleate is about 14.2 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 enalapril maleate (C20H28N2O5·C4H4O4) in the portion of Oral Suspension taken:
Result = (rU/rS) × (CS/CU) × 100
| rU | = | = peak response of enalapril maleate from the Sample solution |
| rS | = | = peak response of enalapril maleate from the Standard solution |
| CS | = | = concentration of enalapril maleate in the Standard solution (mg/mL) |
| CU | = | = nominal concentration of enalapril maleate in the Sample solution (mg/mL) |
Acceptance criteria:
90.0%–110.0%
SPECIFIC TESTS
• pH 791:
2.6–3.6
791:
2.6–3.6
ADDITIONAL REQUIREMENTS
• Packaging and Storage:
Package in tight, light-resistant containers. Store at 2–8 or at controlled room temperature.
–8 or at controlled room temperature.
• Labeling:
Label it to indicate that it is to be shaken vigorously immediately before use, and to state the Beyond-Use Date. Label it to state that it is for veterinary use only.
• Beyond-Use Date:
NMT 90 days after the date on which it was compounded when stored at 2–8; NMT 60 days when stored at controlled room temperature
–8; NMT 60 days when stored at controlled room temperature
• USP Reference Standards 11
11
USP Enalapril Maleate RS 
') + '&img=../../images/v38332/cas-76095-16-4.gif',600,500);)
Auxiliary Information—
Please check for your question in the FAQs before contacting USP.
| Topic/Question | Contact | Expert Committee |
|---|---|---|
| Monograph | Jeanne H. Sun, Pharm.D.
Associate Scientific Liaison (301) 230-3361 |
(CMP2010) Compounding |
| Reference Standards | RS Technical Services 1-301-816-8129 rstech@usp.org |
USP38–NF33 Page 3291
Pharmacopeial Forum: Volume No. 39(4)