Capreomycin for Injection

This article is compiled based on the United States Pharmacopeia (USP) – 2025 Edition

Issued and maintained by the United States Pharmacopeial Convention (USP)

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1 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.

2 IDENTIFICATION

A. IDENTIFICATION TESTS-GENERAL, Sulfate (191)

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.

3 ASSAY

PROCEDURE: Proceed as directed in Antibiotics-Microbial Assays (81).

Acceptance criteria: 90.0%-115.0%

4 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

5 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

(See Chromatography (621), System Suitability.)

Mode: LC

Detector: UV 268 nm

Column: 4.6-mm x 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 = (r_1A+r_1B)/г_T, х 100

r_1A = peak area response for capreomycin 1A

r_1B = peak area response for capreomycin 1B

г_T = 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 and Implanted Drug Products 〈1〉, Specific Tests, Completeness and clarity of solutions.

Other Requirements: It meets the requirements under Injections and Implanted Drug Products 〈1〉.

6 ADDITIONAL REQUIREMENTS

Packaging and Storage: Preserve as described in Packaging and Storage Requirements 〈659〉, Injection Packaging, Packaging for constitution.

USP Reference Standards 〈11〉

USP Capreomycin Sulfate RS