Unlock instant, AI-driven research and patent intelligence for your innovation.
A method for detecting impurities in bivalirudin
What is Al technical title?
Al technical title is built by PatSnap Al team. It summarizes the technical point description of the patent document.
A bivalirudin and impurity technology, applied in the field of medicine, can solve problems such as poor separation effect, and achieve the effect of being suitable for popularization, good detection effect, and simple detection process
Active Publication Date: 2021-11-23
HAINAN ZHONGHE PHARM CO LTD
View PDF0 Cites 0 Cited by
Summary
Abstract
Description
Claims
Application Information
AI Technical Summary
This helps you quickly interpret patents by identifying the three key elements:
Problems solved by technology
Method used
Benefits of technology
Problems solved by technology
These potential impurities are close to the polarity of the main peak of bivalirudin, and the separation effect is not good. Therefore, it is necessary to develop a detection method for impurities in bivalirudin to effectively separate these potential impurities, provide effective support for the subsequent purification and preparation, and ensure Process impurities can be effectively removed to ensure product quality
Method used
the structure of the environmentally friendly knitted fabric provided by the present invention; figure 2 Flow chart of the yarn wrapping machine for environmentally friendly knitted fabrics and storage devices; image 3 Is the parameter map of the yarn covering machine
View more
Image
Smart Image Click on the blue labels to locate them in the text.
Viewing Examples
Smart Image
Click on the blue label to locate the original text in one second.
Reading with bidirectional positioning of images and text.
Smart Image
Examples
Experimental program
Comparison scheme
Effect test
Embodiment 1
[0065] Select the bivalirudin sample whose batch number is 20180701, and perform the detection according to the following steps:
[0068] Mobile phase B: the volume ratio of acetonitrile and methanol is 20:80 mixed configuration;
[0069] Preparation of the test solution: Accurately weigh 20 mg of bivalirudin sample to a 10 ml volumetric flask, add 5 ml of mobile phase A to mix and dissolve, continue diluting mobile phase A to volume, and prepare 2 mg / ml of bivalirudin Sample solution, ready for use;
[0070] Preparation of system suitability solution: Weigh 20 μg each of impurity I, impurity II, impurity III, impurity IV, impurity V, impurity VI, impurity VII, impurity VIII, impurity IX, impurity X, and impurity XI into 10ml volumetric flasks In the same v...
Embodiment 2
[0085] The difference between this example and Example 1 is only that the flow rate parameters in the chromatographic conditions are different, and other detection conditions are consistent with Example 1.
[0086] In this embodiment, the flow rate is 0.8ml / min
[0087] Each impurity in the system suitability solution can achieve baseline separation from the main peak. After detection, it can be seen that only impurity VI (RRT=0.46), impurity X (RRT=0.97) and impurity XI (RRT=1.04) exist in the bivalirudin sample, and their contents are respectively 0.13%, 0.34% and 0.34%, and other Impurities were detected.
Embodiment 3
[0089] The difference between this example and Example 1 is only that the flow rate parameters in the chromatographic conditions are different, and other detection conditions are consistent with Example 1.
[0090] In this embodiment, the flow rate is 1.2ml / min
[0091] Each impurity in the system suitability solution can achieve baseline separation from the main peak. After testing, it can be seen that only impurity VI (RRT=0.47), impurity X (RRT=0.98) and impurity XI (RRT=1.02) exist in the bivalirudin sample, and their contents are 0.13%, 0.30% and 0.31%, respectively, and other Impurities were detected.
the structure of the environmentally friendly knitted fabric provided by the present invention; figure 2 Flow chart of the yarn wrapping machine for environmentally friendly knitted fabrics and storage devices; image 3 Is the parameter map of the yarn covering machine
Login to View More
PUM
Login to View More
Abstract
The invention discloses a method for detecting impurities in bivalirudin, the detection method comprising using high performance liquid chromatography to detect impurities in bivalirudin samples, especially impurities close to the main peak in polarity [D- Phe 12 ]‑Bivalirudin (Impurity I), [L‑Phe 1 ]‑Bivalirudin (Impurity II), [D‑Leu 20 ]‑Bivalirudin (Impurity III), [Plus‑Gly 5 Gly 6 ]‑Bivalirudin (Impurity IV), [Des‑Gly 5 Gly 6 ]-Bivalirudin (impurity V) can be effectively separated from the main peak. The detection limit of each impurity in this method is about 0.15 μg / ml, that is, impurities higher than 0.01% in bivalirudin can be detected; this method can not only effectively detect and separate the 6 impurities disclosed in USP, but also effectively separate other 5 potential process impurities with close polarity, strong practicability, simple and fast detection process.
Description
[0001] field of invention [0002] The invention relates to the technical field of medicine, in particular to a high-efficiency liquid phase method for detecting impurities in bivalirudin. Background technique [0003] The effective anticoagulant component of Bivalirudin is a hirudin derivative fragment, which plays an anticoagulant effect by directly and specifically inhibiting the activity of thrombin, whether the thrombin is in the blood circulation or combined with the thrombus, this product can be used with it Catalytic site and anion binding site) are specifically bound to directly inhibit the activity of thrombin. Its action is different from that of heparin, and it does not depend on antithrombin, heparin cofactors, etc. Thrombin is a serineprotease that plays a central role in coagulation reactions: it hydrolyzes fibrinogen to generate fibrin monomers; activates coagulation factors; promotes fibrin cross-linking to form a covalent structure that stabilizes thrombus,...
Claims
the structure of the environmentally friendly knitted fabric provided by the present invention; figure 2 Flow chart of the yarn wrapping machine for environmentally friendly knitted fabrics and storage devices; image 3 Is the parameter map of the yarn covering machine
Login to View More
Application Information
Patent Timeline
Application Date:The date an application was filed.
Publication Date:The date a patent or application was officially published.
First Publication Date:The earliest publication date of a patent with the same application number.
Issue Date:Publication date of the patent grant document.
PCT Entry Date:The Entry date of PCT National Phase.
Estimated Expiry Date:The statutory expiry date of a patent right according to the Patent Law, and it is the longest term of protection that the patent right can achieve without the termination of the patent right due to other reasons(Term extension factor has been taken into account ).
Invalid Date:Actual expiry date is based on effective date or publication date of legal transaction data of invalid patent.
Login to View More 
Login to View More