(kap'' ree oh mye' sin sul' fate).
Capreomycin sulfate [1405-37-4].
Capreomycin 1A (free base);
Capreomycin 1B (free base);
Capreomycin Sulfate is the disulfate salt of capreomycin, a polypeptide mixture produced by the growth of Streptomyces capreolus, suitable for parenteral use. It has a potency equivalent to NLT 700 µg/mg and NMT 1050 µg/mg 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: 7001050 µg/mg
• 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 Sulfate 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 Sulfate taken:
Result = [(r1A + r1B)/rT] × 100
Acceptance criteria: 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: Where it is intended for use in preparing injectable dosage forms: NMT 0.35 USP Endotoxin Unit/mg of capreomycin
• Other Requirements: Where the label states that Capreomycin Sulfate is sterile, it meets the requirements under Injections 1.
• Packaging and Storage: Preserve in tight containers.
• Labeling: Where it is intended for use in preparing injectable dosage forms, the label states that it is sterile or must be subjected to further processing during the preparation of injectable dosage forms.
• USP Reference Standards 11
USP Endotoxin RS
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USP35NF30 Page 2473Pharmacopeial Forum: Volume No. 35(6) Page 1448