Pantoprazole Oral Suspension
DEFINITION
Pantoprazole Oral Suspension contains NLT 90.0% and NMT 110.0% of the labeled content of pantoprazole sodium. Prepare Pantoprazole Oral Suspension, 2 mg/mL, as follows (see Pharmaceutical Compounding—Nonsterile Preparations 
795
).1
795).1
| Pantoprazole Sodium | 200 mg |
| Sodium Bicarbonate 8.4% Injection, a sufficient quantity to make | 100 mL |
Calculate the required quantity of each ingredient for the total amount to be prepared. Remove the trademark imprint from the tablets by gently rubbing on a paper towel that has been dampened with Alcohol, USP. Allow the tablets to air-dry for a few min. Triturate the tablets to a coarse powder by using a mortar and pestle, and transfer to a calibrated bottle. Add 50 mL of Sodium Bicarbonate 8.4% Injection and agitate until the coating is dissolved. Add sufficient Sodium Bicarbonate 8.4% Injection to bring the final volume to 100 mL and mix well until the powder is uniformly suspended.
[Note—If the imprint is not properly removed, the pharmaceutical elegance of the final product will be compromised by the presence of flecks of dark material. ]
ASSAY
• Procedure
Mobile phase:
Acetonitrile and 50 mM dibasic potassium phosphate (2:3). Adjust with phosphoric acid to a pH of 7.0. Make adjustments if necessary.
Standard stock solution:
1.0 mg/mL of USP Pantoprazole Sodium RS in water
Standard solution:
Transfer 1.5 mL of Standard stock solution to a 100-mL volumetric flask, and dilute with water to volume in order to obtain a solution containing about 15 µg/mL of pantoprazole sodium. Pass through a suitable filter of 0.22-µm pore size.
Sample solution:
Shake thoroughly by hand each bottle of Oral Suspension. Accurately pipet 3.75 mL of Oral Suspension to a 50-mL volumetric flask. Add 25 mL of water to the flask, and place on an orbital shaker for 20 min. Dilute with water to volume. Take a 5-mL portion of the diluted sample and further dilute with water to 50 mL to obtain a solution with a nominal concentration of 15 µg/mL of pantoprazole sodium. Pass through a suitable filter of 0.22-µm pore size.
Chromatographic system
Mode:
LC
Detector:
UV 280 nm
Column:
4.6-mm × 15-cm; 5-µm packing L1
Flow rate:
1.6 mL/min
Injection size:
10 µL
System suitability
Sample:
Standard solution
[Note—The retention time for the pantoprazole peak is about 2.6 min. ]
Suitability requirements
Relative standard deviation:
NMT 1.0% for the replicate injections
Analysis
Samples:
Standard solution and Sample solution
Calculate the percentage of the labeled amount of C16H14F2N3NaO4S·1.5 H2O in the volume of Oral Suspension taken:
Result = (rU/rS) × (CS/CU) × 100
| rU | = | = peak response from the Sample solution |
| rS | = | = peak response from the Standard solution |
| CS | = | = concentration of pantoprazole sodium in the Standard solution (µg/mL) |
| CU | = | = nominal concentration of pantoprazole sodium in the Sample solution (µg/mL) |
Acceptance criteria:
90.0%–110.0%
SPECIFIC TESTS
• pH 791:
Between 7.9 and 8.3
791:
Between 7.9 and 8.3
ADDITIONAL REQUIREMENTS
• Packaging and Storage:
Package in tight, light-resistant containers. Store at controlled cold 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 14 days after the date on which it was compounded when stored at controlled cold temperature
• USP Reference Standards 11
11
USP Pantoprazole Sodium RS
1
This formula is frequently used for home health patients with feeding tubes who have been discharged from hospitals. The goal of the drug is to neutralize the acidity of the stomach.
Auxiliary Information—
Please check for your question in the FAQs before contacting USP.
| Topic/Question | Contact | Expert Committee |
|---|---|---|
| Monograph | Jeanne H. Sun
Assistant Scientific Liaison 1-301-816-3361 |
(CMP2010) Compounding |
| Reference Standards | RS Technical Services 1-301-816-8129 rstech@usp.org |
USP35–NF30 Page 4209
Pharmacopeial Forum: Volume No. 35(4) Page 863