Lansoprazole Compounded Oral Suspension
DEFINITION
Lansoprazole Compounded Oral Suspension contains NLT 90.0% and NMT 110.0% of the labeled amount of lansoprazole (C16H14F3N3O2S). Prepare Lansoprazole Compounded Oral Suspension 3 mg/mL as follows (see Pharmaceutical Compounding—Nonsterile Preparations 
795
).
795).| Lansoprazole delayed-release capsule(s)a
equivalent to |
300 mg |
| Vehicle: A mixture of Ora-Blendb and Sodium Bicarbonate Injection (8.4%) (1:1), a sufficient quantity to make | 100 mL |
|
a
Lansoprazole 30-mg delayed-release capsules, Dr. Reddy's Laboratory Limited, Bridgewater, NJ.
b
Perrigo Pharmaceuticals, Allegan, MI.
|
|
Empty the required number of delayed-release capsules, and pour the contents into a mortar or other suitable container. If necessary, crush the contents into a fine powder by using a pestle or other mechanical means. Wet the powder with a small amount of Vehicle, and triturate to make a smooth paste. Add Vehicle to make the mortar contents pourable. Transfer the contents stepwise and quantitatively to a calibrated container using the remainder of Vehicle. Add sufficient Vehicle to bring to final volume. Shake to mix well.
Alternatively, a compounded 8.4% sodium bicarbonate solution may be used instead of Sodium Bicarbonate Injection (8.4%). Prepare an 8.4% sodium bicarbonate solution by dissolving 8.4 g of Sodium Bicarbonate in sufficient Purified Water to make 100 mL.
ASSAY
• Procedure
Solution A:
10 mM sodium phosphate adjusted with sodium hydroxide to a pH of 7.5. Pass through a nylon filter of 0.45-µm pore size, and degas.
Solution B:
Acetonitrile and water (50:50)
Solution C:
Water adjusted with 1 M sodium hydroxide to a pH of 6.5
Mobile phase:
Acetonitrile and Solution A (45:55)
Standard stock solution:
3 mg/mL of USP Lansoprazole RS in Solution B. 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 500-mL volumetric flask, and dilute with Solution C to volume. Centrifuge an aliquot 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 Oral Suspension to a 500-mL volumetric flask, and dilute with Solution C to volume. Centrifuge an aliquot 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 285 nm
Column:
4.6-mm × 25-cm; 5-µm packing L1
Temperatures
Column:
35
Autosampler:
5
Flow rate:
1.0 mL/min
Injection volume:
20 µL
System suitability
Sample:
Standard solution
[Note—The retention time for lansoprazole is about 5.2 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 lansoprazole (C16H14F3N3O2S) in the portion of Oral Suspension taken:
Result = (rU/rS) × (CS/CU) × 100
| rU | = | = peak response of lansoprazole from the Sample solution |
| rS | = | = peak response of lansoprazole from the Standard solution |
| CS | = | = concentration of lansoprazole in the Standard solution (mg/mL) |
| CU | = | = nominal concentration of lansoprazole in the Sample solution (mg/mL) |
Acceptance criteria:
90.0%–110.0%
SPECIFIC TESTS
• pH 791:
8.0–8.5
791:
8.0–8.5
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 Oral Suspension 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 Lansoprazole 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 4040
Pharmacopeial Forum: Volume No. 39(5)