Capreomycin Sulfate
(kap'' ree oh mye' sin sul' fate).
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Capreomycin sulfate     [1405-37-4].
C25H44N14O8 668.71
Capreomycin 1A (free base);    
3,6-Diamino-N-({(2S,5S,11S,15S,Z)-15-amino-2-(hydroxymethyl)-11-[(R)-iminohexahydropyrimidin-4-yl]-3,6,9,12,16-pentaoxo-8-(ureidomethylene)-1,4,7,10,13-pentaazacyclohexadecan-5-yl}methyl)hexanamide     [37290-35-6].
C25H44N14O7 652.71
Capreomycin 1B (free base);    
3,6-Diamino-N-({(2S,5S,11S,15S,Z)-15-amino-11-[(R)-iminohexahydropyrimidin-4-yl]-2-methyl-3,6,9,12,16-pentaoxo-8-(ureidomethylene)-1,4,7,10,13-pentaazacyclohexadecan-5-yl}methyl)hexanamide     [33490-33-4].
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 Antibiotics—Microbial Assays 81.
Acceptance criteria:  700–1050 µg/mg
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 Sulfate 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 Sulfate taken:
Result = [(r1A + r1B)/rT] × 100
r1A== peak area response of capreomycin 1A
r1B== peak area response of capreomycin 1B
rT== total response for all peaks
Acceptance criteria:  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: 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 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 1448