Capreomycin for Injection
Capreomycin for Injection contains an amount of Capreomycin Sulfate equivalent to NLT 90.0% and NMT 115.0% of the labeled amount of capreomycin.
• B. The retention times of the major peaks of the Sample solution correspond to those of the System suitability solution, as obtained in the test for Capreomycin 1 Content.
• Procedure: Proceed as directed in AntibioticsMicrobial Assays 81.
Acceptance criteria: 90.0%115.0%
• Residue on Ignition 281: NMT 3.0%, the charred residue being moistened with 2 mL of nitric acid and 5 drops of sulfuric acid
• Heavy Metals, Method II 231: NMT 30 ppm
• Capreomycin 1 Content
Solution A: 0.4 mg/mL of ammonium bisulfate in water. Pass through a filter of 0.5-µm or less pore size.
Mobile phase: Methanol and Solution A (2:3)
System suitability solution: 0.25 mg/mL of USP Capreomycin Sulfate RS in water
Sample solution: 0.25 mg/mL of Capreomycin for Injection in water
Detector: UV 268 nm
Column: 4.6-mm × 25-cm; 5-µm packing L10
Column temperature: 30
Flow rate: 1.5 mL/min
Injection size: 20 µL
Sample: System suitability solution
[NoteThe relative retention times of capreomycin 1A and capreomycin 1B are 0.85 and 1.0, respectively. ]
Resolution: NLT 1.5 between capreomycin 1A and capreomycin 1B
Tailing factor: NMT 3.5 for the major peaks (capreomycin 1A and capreomycin 1B)
[NoteThe chromatographic run time is at least five times the retention time of the capreomycin 1A peak. ]
Sample: Sample solution
Calculate the percentage of capreomycin 1 in the portion of Capreomycin for Injection taken:
Result = (r1A + r1B)/rT × 100
Acceptance criteria: The capreomycin 1 content is NLT 90.0%.
• pH 791: 4.57.5
Sample solution: 30 mg/mL
• Loss on Drying 731: Dry 100 mg in a vacuum at a pressure not exceeding 5 mm of mercury at 100 for 4 h: it loses NMT 10.0% of its weight.
• Bacterial Endotoxins Test 85: NMT 0.35 USP Endotoxin Unit/mg of capreomycin
• Constituted Solution: At the time of use, it meets the requirements for Injections 1, Constituted Solutions.
• Other Requirements: It meets the requirements under Injections 1.
• USP Reference Standards 11
USP Endotoxin RS
Auxiliary Information Please check for your question in the FAQs before contacting USP.
USP35NF30 Page 2473Pharmacopeial Forum: Volume No. 35(6) Page 1449