Midazolam contains NLT 98.5% and NMT 101.5% of C18H13ClFN3, calculated on the dried basis.
• B. The retention time of the major peak of the Sample solution corresponds to that of the Standard solution, as obtained in the Assay.
Buffer: 7.7 g/L of ammonium acetate in water. Adjust with glacial acetic acid to a pH of 5.5 ± 0.1.
Mobile phase: Acetonitrile and Buffer (1:2)
Standard solution: 0.04 mg/mL of USP Midazolam RS in Mobile phase
Sample solution: 0.04 mg/mL of Midazolam in Mobile phase
Detector: UV 254 nm
Column: 4.6-mm × 25-cm; 5-µm packing L60
Flow rate: 1.5 mL/min
Injection size: 25 µL
Sample: Standard solution
Column efficiency: NLT 10,000 theoretical plates
Tailing factor: NMT 2.0
Relative standard deviation: NMT 2.0%
Samples: Standard solution and Sample solution
Calculate the percentage of C18H13ClFN3 in the portion of Midazolam taken:
Result = (rU/rS) × (CS/CU) × 100
Acceptance criteria: 98.5%101.5% on the dried basis
• Residue on Ignition 281: NMT 0.1%
Buffer, Mobile phase, Standard solution, and Chromatographic system: Proceed as directed in the Assay.
Sensitivity check solution: Dilute the Standard solution with Mobile phase to obtain a 0.2-µg/mL solution.
Sample solution: 0.2 mg/mL of Midazolam in Mobile phase
Samples: Standard solution and Sensitivity check solution
Column efficiency: NLT 10,000 theoretical plates, Standard solution
Tailing factor: NMT 2.0, Standard solution
Relative standard deviation: NMT 2.0%, Standard solution
Peak ratio: The ratio of the area of the midazolam peak of the Standard solution to the area of the midazolam peak of the Sensitivity check solution should be within 160240.
Sample: Sample solution
Calculate the percentage of each impurity in the portion of Midazolam taken:
Result = (rU/F)/[S(rU/F) + rT] × 100
Acceptance criteria: See Impurity Table 1.
Impurity Table 1
• Loss on Drying 731: Dry a sample at 105 for 2 h: it loses NMT 0.5% of its weight.
• Packaging and Storage: Preserve in tight, light-resistant containers.
• USP Reference Standards 11
USP Midazolam RS
Auxiliary Information Please check for your question in the FAQs before contacting USP.
USP35NF30 Page 3919Pharmacopeial Forum: Volume No. 34(4) Page 961