(ep'' i roo' bi sin hye'' droe klor' ide).
5,12-Naphthacenedione, 10-[(3-amino-2,3,6-trideoxy--l-arabino-hexopyranosyl)oxy]-7,8,9,10-tetrahydro-6,8,11-trihydroxy-8-(hydroxyacetyl)-1-methoxy-, hydrochloride, (8S-cis)-;
(1S,3S)-3-Glycoloyl-1,2,3,4,6,11-hexahydro-3,5,12-trihydroxy-10-methoxy-6,11-dioxo-1-naphthacenyl-3-amino-2,3,6-trideoxy--l-arabino-hexopyranoside hydrochloride. [56390-09-1].
Epirubicin Hydrochloride contains NLT 97.0% and NMT 102.0% of C27H29NO11·HCl, calculated on the anhydrous and solvent-free basis.
• B. The retention time of the major peak of the Sample solution corresponds to that of the Standard solution, as obtained in the Assay.
• C. Identification TestsGeneral, Chloride 191: A 10 mg/mL solution in a mixture of nitric acid and water (1:1) meets the requirements.
[NoteAllow the System suitability solution, Standard solution, and the Sample solution to stand for 3 h before use. ]
Solution A: Dissolve 3.7 g of sodium lauryl sulfate in 950 mL of water. To the resulting solution, add 28 mL of 10% phosphoric acid, and dilute with water to 1000 mL.
Mobile phase: Acetonitrile, methanol, and Solution A (29:17:54)
System suitability solution: 0.1 mg/mL each of USP Epirubicin Hydrochloride RS and USP Doxorubicin Hydrochloride RS in Mobile phase
Standard solution: 1 mg/mL of USP Epirubicin Hydrochloride RS in Mobile phase
Sample solution: 1 mg/mL of Epirubicin Hydrochloride in Mobile phase
Detector: UV 254 nm
Column: 4.6-mm × 25-cm; 6-µm packing L13
Flow rate: 2.5 mL/min
Injection size: 10 µL
Run time: About 3.5 times the retention time of the epirubicin peak
Sample: System suitability solution
Resolution: NLT 2.0 between doxorubicin and epirubicin
Samples: Standard solution and Sample solution
Calculate the percentage of C27H29NO11·HCl in the portion of Epirubicin Hydrochloride taken:
Result = (rU/rS) × (CS/CU) × 100
Acceptance criteria: 97.0%102.0% on the anhydrous and solvent-free basis
• Procedure 1
[NoteAllow the System suitability solution, Sample solution, and Standard solution to stand for 3 h before use. ]
Mobile phase, System suitability solution, Sample solution, Chromatographic system, and System suitability: Proceed as directed in the Assay.
Standard solution: 0.01 mg/mL of USP Epirubicin Hydrochloride RS in Mobile phase
Peak identification solution: Dissolve 10 mg of USP Doxorubicin Hydrochloride RS in 10 mL of a mixture of water and phosphoric acid (1:1). Allow to stand for 30 min. Adjust with 2 N sodium hydroxide solution to a pH of 2.6. Add 15 mL of acetonitrile and 10 mL of methanol, and mix.
Samples: Sample solution, Standard solution, and Peak identification solution[NoteUse the Peak identification solution to identify peaks using the relative retention times in Impurity Table 1. ]
Calculate the percentage of each impurity in the portion of Epirubicin Hydrochloride taken:
Result = (rU/rS) × (CS/CU) × (1/F) × 100
Individual impurities: See Impurity Table 1.
Total impurities: NMT 3.0%
Impurity Table 1
• Procedure 2: Limit of Acetone
Analysis: See Residual Solvents 467.
Acceptance criteria: NMT 1.5%
• Water Determination, Method Ic 921: NMT 4.0%
• pH 791: 4.05.5 for a 5 mg/mL solution
• Bacterial Endotoxins Test 85: NMT 1.1 USP Endotoxin Units/mg, where the label states that Epirubicin Hydrochloride is sterile or must be subjected to further processing during the preparation of injectable dosage forms.
• Packaging and Storage: Store in airtight containers, protected from light, at a temperature between 2 and 8. If the substance is sterile, store in a sterile, airtight, tamper-proof container.
• Labeling: Where applicable, the label states that the substance is free from bacterial endotoxins.
• USP Reference Standards 11
USP Endotoxin RS
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USP35NF30 Page 3058Pharmacopeial Forum: Volume No. 35(2) Page 274