Capreomycin for Injection
DEFINITION
Capreomycin for Injection contains an amount of Capreomycin Sulfate equivalent to NLT 90.0% and NMT 115.0% of the labeled amount of capreomycin.
IDENTIFICATION
• 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.
ASSAY
• Procedure:
Proceed as directed in Antibiotics—Microbial Assays 
81
.
81.
Acceptance criteria:
90.0%–115.0%
IMPURITIES
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
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
231:
NMT 30 ppm
SPECIFIC TESTS
• 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)
Analysis
[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%.
• 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.
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
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.
1, Constituted Solutions.
• Other Requirements:
It meets the requirements under Injections 1.
1.
ADDITIONAL REQUIREMENTS
• Packaging and Storage:
Preserve in Containers for Sterile Solids as described under Injections 1.
1.
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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 1-301-816-8161 |
(SM12010) Monographs - Small Molecules 1 |
| 85 |
Radhakrishna S Tirumalai, Ph.D.
Principal Scientific Liaison 1-301-816-8339 |
(GCM2010) General Chapters - Microbiology |
| Reference Standards | RS Technical Services 1-301-816-8129 rstech@usp.org |
USP35–NF30 Page 2473
Pharmacopeial Forum: Volume No. 35(6) Page 1449