Clopidogrel Compounded Oral Suspension
DEFINITION
Clopidogrel Compounded Oral Suspension contains NLT 90.0% and NMT 110.0% of the labeled amount of clopidogrel (C16H16ClNO2S).
Prepare Clopidogrel Compounded Oral Suspension 5 mg/mL as follows (see Pharmaceutical Compounding—Nonsterile Preparations 
795
).
795).Crush the Clopidogrel tablet(s) to a fine powder using a mortar and pestle or by other mechanical means. Wet the powder with a small amount of Vehicle, and triturate to make a smooth paste. Add the Vehicle to make the contents pourable. Transfer the 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.
ASSAY
• Procedure
Solution A:
10 mM sodium phosphate adjusted with phosphoric acid to a pH of 3.0. Pass through a nylon filter of 0.45-µm pore size, and degas.
Mobile phase:
Acetonitrile and Solution A (65:35)
Diluent:
Water adjusted with phosphoric acid to a pH of 3.0
Standard stock solution:
5 mg/mL of clopidogrel prepared from USP Clopidogrel Bisulfate RS and Diluent. Mix well, and sonicate for 3 min. Store at 2
–8.
–8.
Standard solution:
Transfer 2.0 mL of the Standard stock solution to a 1-L volumetric flask, and dilute with Diluent to volume. Mix well, centrifuge a portion of the solution for 5 min at 14,000 rpm, and use the supernatant. Protect from light, and store at 2–8.
–8.
Sample solution:
Shake each bottle of Oral Suspension thoroughly. Transfer 2.0 mL of the Oral Suspension to a 1-L volumetric flask, and dilute with Diluent to volume. Mix well, centrifuge a portion of the solution for 5 min at 14,000 rpm, and use the supernatant. Protect from light, and store at 2–8.
–8.
Chromatographic system
Mode:
LC
Detector:
UV 235 nm
Column:
2.1-mm × 25-cm; 5-µm packing L7
Temperatures
Column:
35
Autosampler:
5
Flow rate:
0.3 mL/min
Injection volume:
20 µL
System suitability
Sample:
Standard solution
[Note—The retention time for clopidogrel is about 7.4 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 clopidogrel (C16H16ClNO2S) in the portion of Oral Suspension taken:
Result = (rU/rS) × (CS/CU) × 100
| rU | = | = peak response of clopidogrel from the Sample solution |
| rS | = | = peak response of clopidogrel from the Standard solution |
| CS | = | = concentration of clopidogrel in the Standard solution (mg/mL) |
| CU | = | = nominal concentration of clopidogrel in the Sample solution (mg/mL) |
Acceptance criteria:
90.0%–110.0%
SPECIFIC TESTS
• pH 791:
2.1–3.1
791:
2.1–3.1
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 well shaken before use, and to state the Beyond-Use Date.
• Beyond-Use Date:
NMT 90 days after the date on which it was compounded, when stored at 2–8 or at controlled room temperature
–8 or at controlled room temperature
• USP Reference Standards 11
11
USP Clopidogrel Bisulfate RS 
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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 2901
Pharmacopeial Forum: Volume No. 39(5)