Amoxicillin for Oral Suspension
Amoxicillin for Oral Suspension contains the equivalent of NLT 90.0% and NMT 120.0% of the labeled amount of amoxicillin (C16H19N3O5S). It contains one or more suitable buffers, colors, flavors, preservatives, stabilizers, sweeteners, and suspending agents.
• The retention time of the major peak of the Sample solution corresponds to that of the Standard solution, as obtained in the Assay.
Buffer: Dissolve 6.8 g/L of monobasic potassium phosphate in water. Adjust with a 45% (w/w) solution of potassium hydroxide to a pH of 5.0 ± 0.1.
Mobile phase: Acetonitrile and Buffer (1:24)
Standard solution: 1.2 mg/mL of USP Amoxicillin RS in Buffer. [NoteUse this solution within 6 h. ]
Sample solution: Dilute a measured volume of Amoxicillin for Oral Suspension, constituted as directed in the labeling, freshly mixed and free from air bubbles, quantitatively and stepwise in Buffer to obtain a solution containing nominally 1 mg/mL of anhydrous amoxicillin. Pass a portion of this solution through a suitable filter. [NoteUse this solution within 6 h. ]
Detector: UV 230 nm
Column: 4-mm × 25-cm;10-µm packing L1
Flow rate: 1.5 mL/min
Injection size: 10 µL
Sample: Standard solution
Tailing factor: NMT 2.5
Relative standard deviation: NMT 2.0%
Samples: Standard solution and Sample solution
Calculate the percentage of C16H19N3O5S in the Amoxicillin for Oral Suspension taken:
Result = (rU/rS) × (CS/CU) × P × F × 100
Acceptance criteria: 90.0%120.0%
• Uniformity of Dosage Units 905
For solids packaged in single-unit containers: Meets the requirements
• Deliverable Volume 698: Meets the requirements
• pH 791: 5.07.5, in the suspension constituted as directed in the labeling
• Microbial Enumeration Tests 61 and Tests for Specified Microorganisms 62: The total aerobic microbial count does not exceed 103 cfu/g, and the total combined molds and yeasts count does not exceed 102 cfu/g.
• Packaging and Storage: Preserve in tight containers, and store at controlled room temperature.
• USP Reference Standards 11
Auxiliary Information Please check for your question in the FAQs before contacting USP.
USP35NF30 Page 2202Pharmacopeial Forum: Volume No. 36(4) Page 894