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 Antibiotics—Microbial Assays 81.
Acceptance criteria:  90.0%–115.0%
Inorganic Impurities 
•  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
Chromatographic system 
Mode:  LC
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
System suitability 
Sample:  System suitability solution
[Note—The relative retention times of capreomycin 1A and capreomycin 1B are 0.85 and 1.0, respectively. ]
Suitability requirements 
Resolution:  NLT 1.5 between capreomycin 1A and capreomycin 1B
Tailing factor:  NMT 3.5 for the major peaks (capreomycin 1A and capreomycin 1B)
[Note—The 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
r1A== peak area response for capreomycin 1A
r1B== peak area response for capreomycin 1B
rT== total response for all peaks
Acceptance criteria:  The capreomycin 1 content is NLT 90.0%.
•  pH 791: 4.5–7.5
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.
•  Packaging and Storage: Preserve in Containers for Sterile Solids as described under Injections 1.
•  USP Reference Standards 11
USP Capreomycin Sulfate RS Click to View Structure
USP Endotoxin RS
Auxiliary Information— Please check for your question in the FAQs before contacting USP.
Topic/Question Contact Expert Committee
Monograph Ahalya Wise, M.S.
Senior Scientific Liaison
(SM12010) Monographs - Small Molecules 1
85 Radhakrishna S Tirumalai, Ph.D.
Principal Scientific Liaison
(GCM2010) General Chapters - Microbiology
Reference Standards RS Technical Services
USP35–NF30 Page 2473
Pharmacopeial Forum: Volume No. 35(6) Page 1449