Methods of measuring carfilzomib
A dilution and HPLC analysis method addresses the inefficiency of existing methods for carfilzomib concentration determination, achieving precise results.
Patent Information
- Authority / Receiving Office
- HK · HK
- Patent Type
- Applications
- Current Assignee / Owner
- AMGEN INC
- Filing Date
- 2026-05-14
- Publication Date
- 2026-07-17
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Abstract
Description
TRANSLATION OF ABSTRACT AND TITLE Request to Record Designated Patent Application No. EP26156112.0 (Publication No. EP4733756) in Hong Kong Our Ref.: P4799HK00 54) Title: Method for Measurement of Carfilzomib 57) Abstract: This document provides an improved method for determining the concentration of carfilzomib in a sample. The method includes the following steps: diluting the sample with a diluent consisting of water and acetonitrile (volume fraction less than 50%) to form an analytical sample; and performing high-performance liquid chromatography (HPLC) analysis on the analytical sample to determine the concentration of carfilzomib in the sample. Abstract
Claims
1. A method for measuring a carfilzomib concentration of a sample comprising carfilzomib comprising the steps of diluting the sample with a diluent comprising water and 0.1% to 49.9% by volume acetonitrile to form an analytical sample; and subjecting the analytical sample to high performance liquid chromatography (HPLC) to determine the carfilzomib concentration in the sample.
2. The method of claim 1, wherein the sample is obtained from carfilzomib compounding.
3. The method of claim 1, wherein the sample is obtained from a bulk lyophilization solution of carfilzomib.
4. The method of claim 1, wherein the sample is a solubilization sample.
5. The method of claim 1, wherein the sample is a post-dilution sample.
6. The method of claim 1, wherein the sample comprises drug product.
7. The method of any one of claims 1 to 6, wherein the diluent comprises water and less than 49% by volume acetonitrile.
8. The method of any one of claims 1 to 7, wherein the carfilzomib concentration is 3 mg / mL to 8 mg / mL.
9. The method of claim 8, wherein the carfilzomib concentration is 5 mg / mL to 6 mg / mL.
10. The method of any one of claims 1 to 9, wherein the temperature of the analytical sample is 2°C to 8°C prior to HPLC analysis.
11. The method of any one of claims 1 to 9, wherein the temperature of the analytical sample is at room temperature prior to HPLC analysis.
12. The method of any one of claims 3 to 11, further comprising the step of preparing a lyophilizate from the sample.
13. The method of claim 12, wherein the lyophilizate contains 10 mg carfilzomib.
14. The method of claim 12, wherein the lyophilizate contains 30 mg carfilzomib.
15. The method of claim 12, wherein the lyophilizate contains 60 mg carfilzomib.